Study of Endothelial Keratoplasty Outcomes

• Sponsor: Cornea Research Foundation of America (Other)
• Overall Status: Completed
• CT.gov ID: NCT00800111
• Collaborator: (none)
• Enrollment: 2,593
• Location: 1
• Arm: 1
• Duration (Months): 120
• Patients Per Site Per Month: 21.6

Study Details

Study Description

Brief Summary

Endothelial keratoplasty is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. This technique offers many advantages compared with traditional full-thickness cornea transplants. Patients experience minimal change in glasses prescription and usually recover useful vision within weeks. Visual fluctuations are minimal during the healing process. The patient's cornea remains structurally intact and is more resistant to injury.

Endothelial keratoplasty is undergoing rapid and widespread adoption. Between 2005 and 2007, the number of corneas placed by US eye banks for endothelial keratoplasty increased ten-fold (2007 Eye Bank Association of America Annual Report). However, the procedure is less than 10 years old, and little is known about long term outcomes. Endothelial keratoplasty candidates at our center are invited to participate in an open enrollment, prospective study of the long-term outcomes of this procedure.

Condition or Disease	Intervention/Treatment	Phase
Fuchs' Endothelial Corneal Dystrophy; Bullous Keratopathy; Iridocorneal Endothelial Syndrome; Posterior Polymorphous Dystrophy	Procedure: endothelial keratoplasty	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2593 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-enrollment, Prospective Study of Endothelial Keratoplasty Outcomes
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Feb 1, 2018
• Actual Study Completion Date: Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Treatment Endothelial keratoplasty procedure is performed.	Procedure: endothelial keratoplasty; Endothelial keratoplasty is surgical replacement of the corneal endothelial cell layer (the cell layer lining the inner surface of the cornea).; Other Names: Descemet stripping endothelial keratoplasty Descemet stripping automated endothelial keratoplasty Descemet membrane endothelial keratoplasty DSEK DSAEK DMEK

Outcome Measures

Primary Outcome Measures

1. Visual acuity [1, 3, 6, and 12 months and annually]

Secondary Outcome Measures

1. Endothelial cell density [6 months, 12 months and annually]

2. Intraocular pressure [1, 3, 6, 12 months and annually]

3. Manifest refraction [1, 3, 6, 12 months and annually]

4. corneal pachymetry [1, 3, 6, 12 months and annually]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Male or female aged 18 or older

• Scheduled to undergo endothelial keratoplasty

• Able to provide written informed consent.

Exclusion Criteria:

• Age less than 18 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Price Vision Group	Indianapolis	Indiana	United States	46260

Sponsors and Collaborators

• Cornea Research Foundation of America

Investigators

• Principal Investigator: Francis W Price, Jr., MD, Cornea Research Foundation of America

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Cornea Research Foundation of America website

Publications

• Allan BD, Terry MA, Price FW Jr, Price MO, Griffin NB, Claesson M. Corneal transplant rejection rate and severity after endothelial keratoplasty. Cornea. 2007 Oct;26(9):1039-42.
• Price FW Jr, Price MO. Descemet's stripping with endothelial keratoplasty in 200 eyes: Early challenges and techniques to enhance donor adherence. J Cataract Refract Surg. 2006 Mar;32(3):411-8.
• Price FW Jr, Price MO. Descemet's stripping with endothelial keratoplasty in 50 eyes: a refractive neutral corneal transplant. J Refract Surg. 2005 Jul-Aug;21(4):339-45.
• Price FW Jr, Price MO. Endothelial keratoplasty to restore clarity to a failed penetrating graft. Cornea. 2006 Sep;25(8):895-9.
• Price MO, Price FW Jr, Trespalacios R. Endothelial keratoplasty technique for aniridic aphakic eyes. J Cataract Refract Surg. 2007 Mar;33(3):376-9.
• Price MO, Price FW Jr. Descemet's stripping with endothelial keratoplasty: comparative outcomes with microkeratome-dissected and manually dissected donor tissue. Ophthalmology. 2006 Nov;113(11):1936-42. Epub 2006 Aug 28.
• Price MO, Price FW Jr. Endothelial cell loss after descemet stripping with endothelial keratoplasty influencing factors and 2-year trend. Ophthalmology. 2008 May;115(5):857-65. Epub 2007 Sep 14.
• Price MO, Price FW. Descemet's stripping endothelial keratoplasty. Curr Opin Ophthalmol. 2007 Jul;18(4):290-4. Review.
• Vajaranant TS, Price MO, Price FW, Wilensky JT, Edward DP. Intraocular pressure measurements following Descemet stripping endothelial keratoplasty. Am J Ophthalmol. 2008 May;145(5):780-6. doi: 10.1016/j.ajo.2008.01.010. Epub 2008 Mar 10.

• Responsible Party: Cornea Research Foundation of America
• ClinicalTrials.gov Identifier: NCT00800111
• Other Study ID Numbers: CRFA2008-01
• First Posted: Dec 1, 2008
• Last Update Posted: Jan 23, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by Cornea Research Foundation of America: failed penetrating keratoplasty
• Additional relevant MeSH terms: Corneal Dystrophies, Hereditary; Fuchs' Endothelial Dystrophy; Iridocorneal Endothelial Syndrome

Study Results

No Results Posted as of Jan 23, 2019