DETECT: Descemet Endothelial Thickness Comparison Trial

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02373137
• Collaborator: University of California, San Francisco (Other), Stanford University (Other)
• Enrollment: 38
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 100.2
• Patients Per Site: 12.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to compare visual acuity outcomes of two types of endothelial keratoplasty: 1) Ultrathin Descemet's Stripping Endothelial Keratoplasty (DSAEK) or 2) Descemet's Membrane Endothelial Keratoplasty (DMEK). Half of the participants will be randomized to have DSAEK and the other half will have DMEK.

Condition or Disease	Intervention/Treatment	Phase
Keratoplasty; Grafting, Corneal; Transplantation, Corneal; Transplantation, Cornea; Keratoplasty, Lamellar	Procedure: DSAEK; Procedure: DMEK; Device: Endoserter; Drug: Prednisolone; Drug: Ofloxacin; Drug: Tropicamide; Drug: Phenylephrine; Device: Jones Tube	Phase 4

Detailed Description

Corneal transplantation has evolved rapidly in recent years. Lamellar keratoplasty to replace diseased endothelium has led to faster recovery times, fewer complications, and better visual acuity outcomes. Currently, Descemet's Stripping Endothelial Keratoplasty (DSAEK) is the most common procedure because of its relative ease and good outcomes. Newer techniques such as Descemet's Membrane Endothelial Keratoplasty (DMEK), where Descemet's membrane alone is transplanted, has the potential to further improve visual acuity outcomes, produce fewer higher-order corneal aberrations and decrease rejection rates. However, donor preparation, increased intra-operative times, and problems with donor attachment in DMEK are all important limitations.

There are three potential mechanisms by which DMEK may provide better visual acuity outcomes than DSAEK; graft thickness, interface haze and corneal higher-order aberrations. Graft thickness has been correlated with best spectacle corrected visual acuity (BSCVA) outcomes among thinner grafts. One retrospective case series found that 71% of thin endothelial grafts (defined as <131μm) had BSCVA of 20/25 or better while only 50% of thick grafts (defined as ≥131) achieved this. In addition, higher-order aberrations, in particular of the posterior cornea, are increased after DSAEK. Theoretically, given the decreased tissue transplanted after DMEK this would be lessened, however, one retrospective series looking at higher order aberrations in DMEK compared with DSAEK found no difference in posterior aberrations of the central 4.0 mm zone between the two groups. Finally, interface haze may be increased in DSAEK and has been correlated with BSCVA.

Ultrathin DSAEK involves donor preparation with a deep microkeratome pass to produce donor grafts less than 100 um thick. This procedure may have similar results to DMEK but without the technical difficulties. Several large prospective series show similar visual outcome results and rates of immunologic rejection between ultrathin DSAEK and DMEK, however comparisons are difficult. This comparative effectiveness clinical trial could directly address these important issues. The investigators also anticipate that secondary analyses of the trial data will allow us to address several more.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Descemet Endothelial Thickness Comparison Trial
• Actual Study Start Date: Jan 22, 2015
• Actual Primary Completion Date: Apr 4, 2018
• Anticipated Study Completion Date: May 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: DSAEK Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose.	Procedure: DSAEK; Device: Endoserter; The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument.; Drug: Prednisolone; Prednisolone is a corticosteroid used to alleviate swelling post-surgery.; Other Names: Millipred Orapred Omnipred Econopred Flo-Pred ; Drug: Ofloxacin; Ofloxacin is an antibiotic used to treat bacterial infections of the eye.; Other Names: Ocuflox Floxin ; Drug: Tropicamide; Tropicamide is a prescription drug used to dilate pupils during an eye exam.; Other Names: Mydriacyl ; Drug: Phenylephrine; Phenylephrine is a prescription drug used to dilate pupils during an eye exam.
Other: DMEK Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft.	Procedure: DMEK; Drug: Prednisolone; Prednisolone is a corticosteroid used to alleviate swelling post-surgery.; Other Names: Millipred Orapred Omnipred Econopred Flo-Pred ; Drug: Ofloxacin; Ofloxacin is an antibiotic used to treat bacterial infections of the eye.; Other Names: Ocuflox Floxin ; Drug: Tropicamide; Tropicamide is a prescription drug used to dilate pupils during an eye exam.; Other Names: Mydriacyl ; Drug: Phenylephrine; Phenylephrine is a prescription drug used to dilate pupils during an eye exam.; Device: Jones Tube; The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.

Outcome Measures

Primary Outcome Measures

1. Best Spectacle-Corrected Visual Acuity [6 months]

   The BSCVA was recorded at 4 meters by a masked refractionist certified for the study using a protocol adapted from the Age-Related Eye Disease Study using Early Treatment Diabetic Retinopathy Study charts: chart R(2110), chart 1(2111), and chart 2(2112) (Precision Vision, Woodstock, IL).

Secondary Outcome Measures

1. Best Spectacle-Corrected Visual Acuity [3 and 12 months]

   The BSCVA was recorded at 4 meters by a masked refractionist certified for the study using a protocol adapted from the Age-Related Eye Disease Study using Early Treatment Diabetic Retinopathy Study charts: chart R(2110), chart 1(2111), and chart 2(2112) (Precision Vision, Woodstock, IL).

2. Best Spectacle-Corrected Visual Acuity [24 Months]

   The BSCVA was recorded at 4 meters by a masked refractionist certified for the study using a protocol adapted from the Age-Related Eye Disease Study using Early Treatment Diabetic Retinopathy Study charts: chart R(2110), chart 1(2111), and chart 2(2112) (Precision Vision, Woodstock, IL).

3. Endothelial Cell Count [3, 6, 12 months]

4. Endothelial Cell Count [24 months]

5. Corneal Higher-Order Aberrations [3, 6, 12 months]

   Corneal anterior and posterior surface higher-order aberrations (HOA) were measured with Scheimpflug imaging (Pentacam) before surgery and at 3, 6, and 12 months post-operatively. Zernike orders 3-8 were calculated at 4.0- and 6.0-mm-diameter optical zones. The results reported here represent total HOA (Sum of Zernike orders 3-8). Note a single observation was not available for one eye in the DMEK group at 6 months, this was analyzed with last observation carried forward.

6. Corneal Higher-Order Aberrations [24 months]

   As measured by Pentacam

7. Interface Haze [3, 6, 12 months]

   As measured by Pentacam densitometry

8. Interface Haze [24 months]

   As measured by Pentacam densitometry

9. National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ) [Baseline, 12 months]

   The National Eye Institute has developed the validated Visual Functioning Questionnaire (NEI-VFQ) to assess the effect of ocular conditions and vision on patient quality of life. The answers to the questionnaire are transformed into sub-scales, including: general health, general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision. Participants are assigned a numerical value for each sub-scale based on their answers between 0-100, where higher numbers indicate better visual function. These sub-scales are then combined according to National Eye Institute guidelines into an overall composite score for each participant. This overall composite score is also on a scale of 0-100, where higher numbers indicate better visual function. Composite score based on National Eye Institute guidelines.

10. Graft Failure/Graft Rejection [Baseline 12 months]

11. Graft Failure/Graft Rejection [Baseline to 24 months]

Other Outcome Measures

1. Refraction [3, 6, 12, 24 months]

   Manifest refraction using phoropter

2. Graft Thickness [3, 6, 12, 24 months]

   As measured by Optical coherence tomography (OCT) and Pachymetry

3. Operative Times [Baseline]

4. Adverse Events/Complication Rates [3, 6, 12, 24 months]

   composite measure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Damaged or diseased endothelium from Fuchs or Pseudophakic Bullous Keratopathy

• Good candidates for corneal transplantation for either DMEK or DSAEK

• Willingness and ability to undergo a cornea transplantation

• Willingness to participate in follow-up visits

Exclusion Criteria:

• Participants who are decisionally and/or cognitively impaired

• Participants who are not suitable for the DMEK or DSAEK surgeries

• Prior Endothelial Keratoplasty (EK) or any other ophthalmic surgery except uncomplicated cataract surgery

• Indication for surgery that is not suitable for EK (e.g. keratoconus, stromal dystrophies and scars)

• Presence of a condition that increases the probability for failure (e.g., heavily vascularized cornea, uncontrolled uveitis)

• Other primary endothelial dysfunction conditions including posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy

• Aphakia, or anterior chamber intraocular lens (IOL) in study eye prior to or anticipated during EK

• Planned intraocular lens exchange of an anterior chamber IOL with a posterior chamber IOL in study at time of study EK

• Pre-operative central sub-epithelial or stromal scarring that the investigator believes is visually significant and could impact post-operative stromal clarity assessment

• Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours

• Hypotony (Intraocular pressure <10mmHg)

• Uncontrolled (defined as intraocular pressure >25mmHg) glaucoma Visually significant optic nerve or macular pathology

• Visually significant optic nerve or macular pathology

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Byers Eye Institute, Stanford University	Palo Alto	California	United States	94303
2	F. I. Proctor Foundation, University of California, San Francisco	San Francisco	California	United States	94143
3	Casey Eye Institute, Oregon Health & Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

• Oregon Health and Science University
• University of California, San Francisco
• Stanford University

Investigators

• Principal Investigator: Winston Chamberlain, MD, PhD, Oregon Health and Science University
• Principal Investigator: Jennifer Rose-Nussbaumer, MD, University of California, San Francisco
• Principal Investigator: Charles Lin, MD, Stanford University

Study Documents (Full-Text)

• Study Protocol - Oct 2, 2017
• Statistical Analysis Plan - Nov 7, 2017

More Information

Publications

• Busin M, Madi S, Santorum P, Scorcia V, Beltz J. Ultrathin descemet's stripping automated endothelial keratoplasty with the microkeratome double-pass technique: two-year outcomes. Ophthalmology. 2013 Jun;120(6):1186-94. doi: 10.1016/j.ophtha.2012.11.030. Epub 2013 Mar 1.
• Chen ES, Terry MA, Shamie N, Hoar KL, Friend DJ. Descemet-stripping automated endothelial keratoplasty: six-month results in a prospective study of 100 eyes. Cornea. 2008 Jun;27(5):514-20. doi: 10.1097/ICO.0b013e3181611c50.
• Dirisamer M, van Dijk K, Dapena I, Ham L, Oganes O, Frank LE, Melles GR. Prevention and management of graft detachment in descemet membrane endothelial keratoplasty. Arch Ophthalmol. 2012 Mar;130(3):280-91. doi: 10.1001/archophthalmol.2011.343. Epub 2011 Nov 14.
• Guerra FP, Anshu A, Price MO, Giebel AW, Price FW. Descemet's membrane endothelial keratoplasty: prospective study of 1-year visual outcomes, graft survival, and endothelial cell loss. Ophthalmology. 2011 Dec;118(12):2368-73. doi: 10.1016/j.ophtha.2011.06.002. Epub 2011 Aug 27.
• Ham L, Dapena I, van Luijk C, van der Wees J, Melles GR. Descemet membrane endothelial keratoplasty (DMEK) for Fuchs endothelial dystrophy: review of the first 50 consecutive cases. Eye (Lond). 2009 Oct;23(10):1990-8. doi: 10.1038/eye.2008.393. Epub 2009 Jan 30.
• Kruse FE, Laaser K, Cursiefen C, Heindl LM, Schlötzer-Schrehardt U, Riss S, Bachmann BO. A stepwise approach to donor preparation and insertion increases safety and outcome of Descemet membrane endothelial keratoplasty. Cornea. 2011 May;30(5):580-7.
• Price FW Jr, Price MO. Evolution of endothelial keratoplasty. Cornea. 2013 Nov;32 Suppl 1:S28-32. doi: 10.1097/ICO.0b013e3182a0a307. Review.
• Rudolph M, Laaser K, Bachmann BO, Cursiefen C, Epstein D, Kruse FE. Corneal higher-order aberrations after Descemet's membrane endothelial keratoplasty. Ophthalmology. 2012 Mar;119(3):528-35. doi: 10.1016/j.ophtha.2011.08.034. Epub 2011 Dec 22.

• Responsible Party: Winston Chamberlain, MD, PhD, Ophthalmologist, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT02373137
• Other Study ID Numbers: IRB00010818
• First Posted: Feb 26, 2015
• Last Update Posted: Nov 25, 2020
• Last Verified: Nov 1, 2020

• Additional relevant MeSH terms: Ofloxacin; Prednisolone; Phenylephrine; Oxymetazoline; Tropicamide

Study Results

Participant Flow

Arm/Group Title	UT-DSAEK	DMEK
Arm/Group Description	Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose. UT-DSAEK Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument. Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.	Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft. DMEK Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam. Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.
Period Title: Overall Study
STARTED	19	19
3-Month Follow-Up	19	19
6-Month Follow-Up	19	18
12-Month Follow-Up	19	19
COMPLETED	18	18
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	UT-DSAEK	DMEK	Total
Arm/Group Description	Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose. UT-DSAEK Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument. Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.	Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft. DMEK Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam. Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.	Total of all reporting groups
Overall Participants	19	19	38
Overall eyes	25	25	50
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	68	68	68
Sex: Female, Male (eyes) [Count of Units]
Female	16	13	29
Male	9	12	21
Race (NIH/OMB) (eyes) [Count of Units]
American Indian or Alaska Native	0	0	0
Asian	1	1	2
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	24	24	48
More than one race	0	0	0
Unknown or Not Reported	0	0	0
Region of Enrollment (eyes) [Number]
United States	25	25	50
Diagnosis (eyes) [Count of Units]
Fuch's Dystrophy	24	24	48
Pseudophakic Bullous Keratopathy	1	1	2
Best Spectacle-Corrected Visual Acuity (logMAR) (logMAR) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [logMAR]	0.27 (0.21)	0.34 (0.29)	0.30 (0.25)
Surgery (eyes) [Count of Units]
Pseudophakic Endothelial Keratoplasty	8	7	15
Triple Endothelial Keratoplasty	17	18	35
Donor Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	64	62	63
Donor Sex (eyes) [Count of Units]
Female	8	5	13
Male	17	20	37
Donor Death to Preservation Time (hours) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [hours]	9 (4)	9 (3)	9 (4)
Donor Death to Surgery Time (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	6 (1)	6 (1)	6 (1)
Donor Endothelial Cell Count (pre-processing) (cells/mm^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cells/mm^2]	2792 (210)	2797 (222)	2795 (214)
Donor Endothelial Cell Count (post-processing) (cells/mm^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cells/mm^2]	2796 (238)	2771 (150)	2783 (197)
Donor Central Graft Thickness (UT-DSAEK only) (mm) [Mean (Full Range) ]
Mean (Full Range) [mm]	73	NA	73
Central Corneal Thickness (microns) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [microns]	610 (44)	608 (52)	609 (48)
Spherical Equivalent (diopters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [diopters]	-0.4 (1.9)	-0.8 (2.2)	-0.6 (2.0)

Outcome Measures

1. Primary Outcome

Title	Best Spectacle-Corrected Visual Acuity
Description	The BSCVA was recorded at 4 meters by a masked refractionist certified for the study using a protocol adapted from the Age-Related Eye Disease Study using Early Treatment Diabetic Retinopathy Study charts: chart R(2110), chart 1(2111), and chart 2(2112) (Precision Vision, Woodstock, IL).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

One patient lost to followup

Arm/Group Title	UT-DSAEK	DMEK
Arm/Group Description	Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose. UT-DSAEK Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument. Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.	Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft. DMEK Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam. Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.
Measure Participants	19	18
Measure eyes	25	24
Mean (Standard Deviation) [logMAR]	0.22 (0.16)	0.05 (0.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	UT-DSAEK, DMEK
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Linear
	Comments	Multiple linear regression model with a covariate for baseline visual acuity.
Method of Estimation	Estimation Parameter	Coefficient
	Estimated Value	-1.8
	Confidence Interval	(2-Sided) 95%; -2.8 to -1.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Coefficient reported in lines, comparing DMEK to UT-DSAEK. Compared to UT-DSAEK, DMEK had 1.8 lines better vision at 6 months.

2. Secondary Outcome

Title	Best Spectacle-Corrected Visual Acuity
Description	The BSCVA was recorded at 4 meters by a masked refractionist certified for the study using a protocol adapted from the Age-Related Eye Disease Study using Early Treatment Diabetic Retinopathy Study charts: chart R(2110), chart 1(2111), and chart 2(2112) (Precision Vision, Woodstock, IL).
Time Frame	3 and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	UT-DSAEK	DMEK
Arm/Group Description	Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose. UT-DSAEK Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument. Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.	Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft. DMEK Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam. Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.
Measure Participants	19	19
Measure eyes	25	25
3 Months	0.24 (0.21)	0.11 (0.13)
12 Months	0.16 (0.18)	0.04 (0.12)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	UT-DSAEK, DMEK
	Comments	Comparison of 3-Month Visual Acuity Between Groups
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Regression, Linear
	Comments	Multiple linear regression model with a covariate for baseline visual acuity
Method of Estimation	Estimation Parameter	Coefficient
	Estimated Value	-1.5
	Confidence Interval	(2-Sided) 95%; -2.5 to -0.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Coefficient reported in lines, comparing DMEK to UT-DSAEK. Compared to UT-DSAEK, DMEK had 1.5 lines better vision at 3 months.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	UT-DSAEK, DMEK
	Comments	Comparison of 12 Month Visual Acuity Between Groups
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Linear
	Comments	Multiple linear regression model with a covariate for baseline visual acuity
Method of Estimation	Estimation Parameter	Coefficient
	Estimated Value	-1.4
	Confidence Interval	(2-Sided) 95%; -2.2 to -0.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Coefficient reported in lines, comparing DMEK to UT-DSAEK. Compared to UT-DSAEK, DMEK had 1.4 lines better vision at 12 months.

3. Secondary Outcome

Title	Best Spectacle-Corrected Visual Acuity
Description	The BSCVA was recorded at 4 meters by a masked refractionist certified for the study using a protocol adapted from the Age-Related Eye Disease Study using Early Treatment Diabetic Retinopathy Study charts: chart R(2110), chart 1(2111), and chart 2(2112) (Precision Vision, Woodstock, IL).
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	UT-DSAEK	DMEK
Arm/Group Description	Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose. UT-DSAEK Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument. Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.	Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft. DMEK Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam. Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.
Measure Participants	19	19
Measure eyes	25	25
Mean (Standard Deviation) [LogMar]	0.15 (0.15)	0.09 (0.16)

4. Secondary Outcome

Title	Endothelial Cell Count
Time Frame	3, 6, 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	UT-DSAEK	DMEK
Arm/Group Description	Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose. UT-DSAEK Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument. Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.	Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft. DMEK Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam. Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.
Measure Participants	19	19
Measure eyes	25	25
3 Months	2114 (357)	2037 (495)
6 Months	2113 (301)	1963 (425)
12 Months	2070 (292)	1855 (448)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	UT-DSAEK, DMEK
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.53
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Coefficient
	Estimated Value	-77
	Confidence Interval	(2-Sided) 95%; -326 to 172
	Parameter Dispersion	Type: Value:
	Estimation Comments	Comparing DMEK to UT-DSAEK at 3 months.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	UT-DSAEK, DMEK
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.17
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Coefficient
	Estimated Value	-150
	Confidence Interval	(2-Sided) 95%; -356 to 66
	Parameter Dispersion	Type: Value:
	Estimation Comments	Comparing DMEK to UT-DSAEK at 6 months.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	UT-DSAEK, DMEK
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.051
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Coefficient
	Estimated Value	-215
	Confidence Interval	(2-Sided) 95%; -430 to -0.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Comparing DMEK to UT-DSAEK at 12 months.

5. Secondary Outcome

Title	Endothelial Cell Count
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	UT-DSAEK	DMEK
Arm/Group Description	Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose. UT-DSAEK Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument. Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.	Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft. DMEK Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam. Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.
Measure Participants	19	19
Measure eyes	25	25
Mean (Standard Deviation) [cells/mm^2]	1626 (362)	1400 (498)

6. Secondary Outcome

Title	Corneal Higher-Order Aberrations
Description	Corneal anterior and posterior surface higher-order aberrations (HOA) were measured with Scheimpflug imaging (Pentacam) before surgery and at 3, 6, and 12 months post-operatively. Zernike orders 3-8 were calculated at 4.0- and 6.0-mm-diameter optical zones. The results reported here represent total HOA (Sum of Zernike orders 3-8). Note a single observation was not available for one eye in the DMEK group at 6 months, this was analyzed with last observation carried forward.
Time Frame	3, 6, 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	UT-DSAEK	DMEK
Arm/Group Description	Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose. UT-DSAEK Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument. Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.	Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft. DMEK Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam. Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.
Measure Participants	19	19
Measure eyes	25	25
3 Months Anterior Cornea 4.0-mm	0.274 (0.223)	0.288 (0.104)
3 Months Posterior Cornea 4.0-mm	0.217 (0.110)	0.116 (0.056)
3 Months Anterior Cornea 6.0-mm	0.897 (0.800)	0.829 (0.367)
3 Months Posterior Cornea 6.0-mm	0.621 (0.308)	0.346 (0.153)
6 Months Anterior Cornea 4.0-mm	0.230 (0.110)	0.243 (0.100)
6 Months Posterior Cornea 4.0-mm	0.179 (0.067)	0.095 (0.031)
6 Months Anterior Cornea 6.0-mm	0.739 (0.371)	0.724 (0.337)
6 Months Posterior Cornea 6.0-mm	0.505 (0.217)	0.288 (0.089)
12 Months Anterior Cornea 4.0-mm	0.228 (0.108)	0.241 (0.100)
12 Months Posterior Cornea 4.0-mm	0.159 (0.068)	0.098 (0.028)
12 Months Anterior Cornea 6.0-mm	0.725 (0.344)	0.723 (0.328)
12 Months Posterior Cornea 6.0-mm	0.459 (0.206)	0.284 (0.073)

7. Secondary Outcome

Title	Corneal Higher-Order Aberrations
Description	As measured by Pentacam
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DSAEK	DMEK
Arm/Group Description	Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose. DSAEK Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument. Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.	Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft. DMEK Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam. Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.
Measure Participants	19	19
Measure eyes	25	25
24 Months Anterior Cornea 4.0-mm	0.215 (0.136)	0.211 (0.008)
24 Months Posterior Cornea 4.0-mm	0.155 (0.075)	0.086 (0.029)
24 Months Anterior Cornea 6.0-mm	0.707 (0.389)	0.679 (0.314)
24 Months Posterior Cornea 6.0-mm	0.450 (0.216)	0.260 (0.008)

8. Secondary Outcome

Title	Interface Haze
Description	As measured by Pentacam densitometry
Time Frame	3, 6, 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	UT-DSAEK	DMEK
Arm/Group Description	Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose. UT-DSAEK Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument. Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.	Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft. DMEK Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam. Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.
Measure Participants	19	19
Measure eyes	25	25
Mild Interface Haze at 3 months	2	1
Moderate Interface Haze at 3 months	0	0
Severe Interface Haze at 3 months	0	0
Mild Interface Haze at 6 months	2	1
oderate Interface Haze at 6 months	1	0
Severe Interface Haze at 6 months	0	0
Mild Interface Haze at 12 months	0	0
oderate Interface Haze at 12 months	0	0
Severe Interface Haze at 12 months	0	0

9. Secondary Outcome

Title	Interface Haze
Description	As measured by Pentacam densitometry
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	UT-DSAEK	DMEK
Arm/Group Description	Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose. UT-DSAEK Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument. Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.	Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft. DMEK Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam. Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.
Measure Participants	19	19
Measure eyes	25	25
Mild Interface Haze at 24 months	0	0
Moderate Interface Haze at 24 months	1	0
Severe Interface Haze at 24 months	0	0

10. Secondary Outcome

Title	National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ)
Description	The National Eye Institute has developed the validated Visual Functioning Questionnaire (NEI-VFQ) to assess the effect of ocular conditions and vision on patient quality of life. The answers to the questionnaire are transformed into sub-scales, including: general health, general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision. Participants are assigned a numerical value for each sub-scale based on their answers between 0-100, where higher numbers indicate better visual function. These sub-scales are then combined according to National Eye Institute guidelines into an overall composite score for each participant. This overall composite score is also on a scale of 0-100, where higher numbers indicate better visual function. Composite score based on National Eye Institute guidelines.
Time Frame	Baseline, 12 months

Outcome Measure Data

Analysis Population Description

For this analysis, all "second eyes" (enrolled eyes belonging to a patient that had enrolled their other eye and already had surgery on that eye as part of this study) were removed. For this reason the total number of eyes equals the total number of participants.

Arm/Group Title	UT-DSAEK	DMEK
Arm/Group Description	Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose. UT-DSAEK Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument. Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.	Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft. DMEK Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam. Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.
Measure Participants	19	19
Measure eyes	19	19
Baseline	72.5 (13.4)	72.3 (15.2)
12 Months	85.9 (9.1)	87.3 (9.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	UT-DSAEK, DMEK
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.70
	Comments
	Method	t-test, 2 sided
	Comments

11. Secondary Outcome

Title	Graft Failure/Graft Rejection
Time Frame	Baseline 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	UT-DSAEK	DMEK
Arm/Group Description	Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose. UT-DSAEK Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument. Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.	Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft. DMEK Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam. Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.
Measure Participants	19	19
Measure eyes	25	25
Graft Rejection	0	0
Graft Failure	1	1

12. Secondary Outcome

Title	Graft Failure/Graft Rejection
Time Frame	Baseline to 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DSAEK	DMEK
Arm/Group Description	Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose. DSAEK Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument. Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.	Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft. DMEK Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam. Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.
Measure Participants	19	19
Measure eyes	25	25
Graft Rejection	0	0
Graft Failure	1	1
Eyes with No Graft Failure or Rejection	24	24

13. Other Pre-specified Outcome

Title	Refraction
Description	Manifest refraction using phoropter
Time Frame	3, 6, 12, 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

14. Other Pre-specified Outcome

Title	Graft Thickness
Description	As measured by Optical coherence tomography (OCT) and Pachymetry
Time Frame	3, 6, 12, 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	UT-DSAEK	DMEK
Arm/Group Description	Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose. UT-DSAEK Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument. Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.	Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft. DMEK Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam. Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.
Measure Participants	19	19
Measure eyes	25	25
3 months	589.36	516.5
6 months	592.24	519.67
12 months	585.96	521.36
24 months	593.67	526.88

15. Other Pre-specified Outcome

Title	Operative Times
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

16. Other Pre-specified Outcome

Title	Adverse Events/Complication Rates
Description	composite measure
Time Frame	3, 6, 12, 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	UT-DSAEK	DMEK
Arm/Group Description	Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose. UT-DSAEK Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument. Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.	Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft. DMEK Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam. Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.
Measure Participants	19	19
Measure eyes	25	25
Adverse Events at 3 months	4	6
Adverse Events at 6 months	4	5
Adverse Events at 12 months	1	4
Adverse Events at 24 months	0	0

Adverse Events

Time Frame	24 months
Adverse Event Reporting Description	Adverse events are reported by eye (N = 50), not by participant (N = 38).
Arm/Group Title	UT-DSAEK		DMEK
Arm/Group Description	Type of corneal transplant; Tissue grafts will be cut to the right thickness using a microkeratome prepared at the eye bank per standard eye bank protocol (about 60-90 microns thick). A 4 mm corneal incision will be used, with Endoserter as the means of inserting the graft, an FDA approved device for this purpose. UT-DSAEK Endoserter: The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument. Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam.		Type of corneal transplant; Endothelial grafts will be pre-peeled at the eyebank (70%). In the operating room the remaining 30% will be peeled, and the endothelium will be stained with trypan blue. A 3.5 mm corneal incision will be used and the graft will be inserted with a modified jones tube injector. The tap technique will be used to position the graft. DMEK Prednisolone: Prednisolone is a corticosteroid used to alleviate swelling post-surgery. Ofloxacin: Ofloxacin is an antibiotic used to treat bacterial infections of the eye. Tropicamide: Tropicamide is a prescription drug used to dilate pupils during an eye exam. Phenylephrine: Phenylephrine is a prescription drug used to dilate pupils during an eye exam. Jones Tube: The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.
All Cause Mortality
	UT-DSAEK		DMEK
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Serious Adverse Events
	UT-DSAEK		DMEK
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	UT-DSAEK		DMEK
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/25 (36%)		7/25 (28%)
Eye disorders
Glaucoma (nonsurgical)	2/25 (8%)		2/25 (8%)
Glaucoma (surgical)	1/25 (4%)		1/25 (4%)
Graft displacement	1/25 (4%)		0/25 (0%)
Graft failure	1/25 (4%)		1/25 (4%)
Graft rejection	0/25 (0%)		0/25 (0%)
Infectious keratitis	0/25 (0%)		0/25 (0%)
Posterior synechiae	0/25 (0%)		1/25 (4%)
Re-bubble	1/25 (4%)		6/25 (24%)
Retinal tear	0/25 (0%)		1/25 (4%)
Visually significant central epithelial opacity	1/25 (4%)		0/25 (0%)
Intralocular lens repositioning	0/25 (0%)		1/25 (4%)
Epiretinal membrane and lamellar hole	0/25 (0%)		1/25 (4%)
Cystoid macular edema	0/25 (0%)		1/25 (4%)
Visual disturbance	1/25 (4%)		1/25 (4%)
Postoperative day 1 pupillary block	1/25 (4%)		0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.