OCT-guided LALAK for KCN

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01901614
• Collaborator: National Institutes of Health (NIH) (NIH), National Eye Institute (NEI) (NIH)
• Enrollment: 5
• Location: 1
• Arms: 2
• Duration (Months): 49
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if a new procedure, called laser-assisted lamellar anterior keratoplasty (LALAK), can achieve the same level of vision with a lower risk of potential complications after surgery compared to another corneal transplant procedure. The current procedure is called Intralase-enabled keratoplasty (IEK) and replaces the entire cornea.

The LALAK procedure involves transplanting only the top layers of the cornea instead of the entire cornea. Only one eye will have this experimental procedure performed. If both eyes need to have surgery your doctor will help you decide on the best non-study option for your other eye.

Condition or Disease	Intervention/Treatment	Phase
Corneal Opacity; Keratoconus	Procedure: LALAK; Procedure: IEK; Drug: Retrobulbar Block or General Anesthesia; Device: optical coherence tomography (OCT); Drug: Topical Anesthesia; Device: femtosecond laser	N/A

Detailed Description

Corneal transplantation (keratoplasty) is the most common organ transplant, with 42,606 procedures in the U.S. in 2009. Many surgeons are moving away from full thickness corneal transplantation, also called penetrating keratoplasty (PK), because of risks involving rejection, irregular astigmatism and wound dehiscence. They are moving towards partial thickness (lamellar) transplantations of either the anterior or posterior (endothelial) layers, which can reduce these risks.

The femtosecond laser has been used to create excellent tongue-in-groove junctions between the graft and host in full thickness PK.1 This technique, called IEK (Intralase-enabled keratoplasty), has now become a standard surgical procedure. The tongue-in-groove junction achieved at the circumferential edge of the graft and host leads to a continuous smooth anterior surface and strong wound healing.

The new technique is called dovetail LALAK. In this technique, the femtosecond laser is used to create a 31% anterior lamellar graft with dove tailed side cuts. It is also used to create a shallow anterior lamellar dissection and beveled side cuts on the recipient cornea to match with the dovetail graft.

In the new technique, the depth of the graft and donor dissections will be guided by OCT measurements. The proposed trial will test if the new technique can reproducibly achieve good visual outcomes without the risk of rejection. The outcome of the LALAK procedure will be compared to that of IEK.

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: RANDOMIZED CLINICAL TRIAL OF OCT-GUIDED LASER-ASSISTED LAMELLAR ANTERIOR KERATOPLASTY IN ADULTS FOR KERATOCONUS
• Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Aug 31, 2017
• Actual Study Completion Date: Aug 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LALAK laser-assisted lamellar anterior keratoplasty. Optical Coherence Tomography, femtosecond laser, topical anesthesia, and Retrobulbar Block or General Anesthesia will be used.	Procedure: LALAK; A "dovetail" shaped cut will be made on the graft using a femtosecond laser at the eye bank. The cut depth will be proportional to the central stromal thickness of the graft. This graft will be separated from stromal bed by eye bank personnel for examination of the cut surface. High-quality graft will be replaced in preservation medium and shipped to the surgeon prior to surgery. The host cornea will receive femtosecond laser cut consisting of a shallow lamellar cut with angled side cut to match the dovetail graft in a tongue-in-groove fashion. The femtosecond laser treatments will be performed under topical anesthesia in the laser suite. The femtosecond laser is an FDA-approved device for use in this indication (corneal transplantation including lamellar keratoplasty). A protective eye shield is placed over the eye. The graft will be sutured into the host bed.; Device: optical coherence tomography (OCT); OCT will be used to guide the depth of the graft and donor dissections.; Drug: Topical Anesthesia; Device: femtosecond laser; The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty. Eye banks use earlier versions of the Intralase system which are also FDA approved for this indication.
Active Comparator: IEK Intralase-enabled keratoplasty. Femtosecond laser and Retrobulbar Block or General Anesthesia will be used.	Procedure: IEK; A full thickness graft will be prepared at the eye bank with zigzag side cuts prepared with a femtosecond laser. The graft is separated from the rim, replaced in the preservation medium, and shipped to the surgeon prior to the surgery. In the laser suite, the host cornea will be cut with the femtosecond laser with zigzag side cuts leaving a 70-100 micron bridge. A protective eye shield is placed over the eye. The graft will be sutured into the host bed.; Drug: Retrobulbar Block or General Anesthesia; Device: femtosecond laser; The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty. Eye banks use earlier versions of the Intralase system which are also FDA approved for this indication.

Outcome Measures

Primary Outcome Measures

1. Does LALAK Achieve the Same Level of Post-operative BSCVA as IEK. [24 months]

   The primary goal of the trial is to determine if LALAK can achieve the same level of postoperative Best Spectacle Corrected Visual Acuity (BSCVA) guided by OCT as IEK. The BSCVA will be measured using a clinic Snellen chart and recorded in the typical Snellen fraction (20/xx) in feet. This will be converted to logMAR form for statistical analysis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Eyes with keratoconus that cannot be adequately or safely corrected with spectacles, contact lens or excimer laser surface ablation. The cornea must have healthy endothelium (endothelial cell density > 1,500/mm2).

Exclusion Criteria:

1. Preoperative corneal thickness less than 400 microns.

2. Corneal edema

3. Central guttata

4. Inability to give informed consent.

5. Inability to maintain stable fixation for OCT imaging.

6. Inability to commit to required visits to complete the study.

7. Eyes with concurrent cataract, retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery.

8. Patients with severe collagen vascular diseases or ocular surface disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Casey Eye Institute, Oregon Health & Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

• Oregon Health and Science University
• National Institutes of Health (NIH)
• National Eye Institute (NEI)

Investigators

• Principal Investigator: Winston Chamberlain, MD, PhD, Oregon Health and Science University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 19, 2015

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: David Huang, Winston Chamberlain, MD, PhD, Assistant Professor of Ophthalmology, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT01901614
• Other Study ID Numbers: OHSU IRB00009280- PTK; R01EY018184
• First Posted: Jul 17, 2013
• Last Update Posted: Jan 23, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by David Huang, Winston Chamberlain, MD, PhD, Assistant Professor of Ophthalmology, Oregon Health and Science University: Keratoconus; Corneal Opacity; Keratoplasty
• Additional relevant MeSH terms: Keratoconus; Corneal Opacity; Anesthetics

Study Results

Participant Flow

Arm/Group Title	Laser-assisted Lamellar Anterior Keratoplasty	Intralase-enabled Keratoplasty
Arm/Group Description	Laser-assisted lamellar anterior keratoplasty LALAK: a. A "dovetail" shaped cut will be made on the graft using a femtosecond laser at the eye bank. The cut depth will be proportional to the central stromal thickness of the graft. This graft will be separated from stromal bed by eye bank personnel for examination of the cut surface. b. The host cornea will receive femtosecond laser cut consisting of a shallow lamellar cut with angled side cut to match the dovetail graft in a tongue-in-groove fashion. The FDA-approved femtosecond laser treatments will be performed under topical anesthesia in the laser suite. optical coherence tomography (OCT): OCT will be used to guide the depth of the graft and donor dissections. Topical Anesthesia femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA).	Intralase-enabled keratoplasty. IEK: a. A full thickness graft will be prepared at the eye bank with zigzag side cuts prepared with a femtosecond laser. The graft is separated from the rim, replaced in the preservation medium, and shipped to the surgeon prior to the surgery. b. In the laser suite, the host cornea will be cut with the femtosecond laser with zigzag side cuts leaving a 70-100 micron bridge. A protective eye shield is placed over the eye. The graft will be sutured into the host bed. Retrobulbar Block or General Anesthesia femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty. Eye banks use earlier versions of the Intralase system which are also FDA approved for this indication.
Period Title: Overall Study
STARTED	3	2
COMPLETED	1	1
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Laser-assisted Lamellar Anterior Keratoplasty	Intralase-enabled Keratoplasty	Total
Arm/Group Description	LALAK: a. A "dovetail" shaped cut will be made on the graft using a femtosecond laser at the eye bank. The cut depth will be proportional to the central stromal thickness of the graft. This graft will be separated from stromal bed by eye bank personnel for examination of the cut surface. b. The host cornea will receive femtosecond laser cut consisting of a shallow lamellar cut with angled side cut to match the dovetail graft in a tongue-in-groove fashion. The FDA-approved femtosecond laser treatments will be performed under topical anesthesia in the laser suite. optical coherence tomography (OCT): OCT will be used to guide the depth of the graft and donor dissections. Topical Anesthesia femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty.	IEK: a. A full thickness graft will be prepared at the eye bank with zigzag side cuts prepared with a femtosecond laser. The graft is separated from the rim, replaced in the preservation medium, and shipped to the surgeon prior to the surgery. b. In the laser suite, the host cornea will be cut with the femtosecond laser with zigzag side cuts leaving a 70-100 micron bridge. A protective eye shield is placed over the eye. The graft will be sutured into the host bed. Retrobulbar Block or General Anesthesia femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty. Eye banks use earlier versions of the Intralase system which are also FDA approved for this indication.	Total of all reporting groups
Overall Participants	3	2	5
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 100%	2 100%	5 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	2 66.7%	1 50%	3 60%
Male	1 33.3%	1 50%	2 40%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 33.3%	0 0%	1 20%
Not Hispanic or Latino	2 66.7%	2 100%	4 80%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	3 100%	2 100%	5 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	3 100%	2 100%	5 100%

Outcome Measures

1. Primary Outcome

Title	Does LALAK Achieve the Same Level of Post-operative BSCVA as IEK.
Description	The primary goal of the trial is to determine if LALAK can achieve the same level of postoperative Best Spectacle Corrected Visual Acuity (BSCVA) guided by OCT as IEK. The BSCVA will be measured using a clinic Snellen chart and recorded in the typical Snellen fraction (20/xx) in feet. This will be converted to logMAR form for statistical analysis.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

For the LALAK group, there were 3 subjects enrolled, but one was a screen fail so no data was obtained for that subject.

Arm/Group Title	Laser-assisted Lamellar Anterior Keratoplasty	Intralase-enabled Keratoplasty
Arm/Group Description	LALAK: a. A "dovetail" shaped cut will be made on the graft using a femtosecond laser at the eye bank. The cut depth will be proportional to the central stromal thickness of the graft. This graft will be separated from stromal bed by eye bank personnel for examination of the cut surface. b. The host cornea will receive femtosecond laser cut consisting of a shallow lamellar cut with angled side cut to match the dovetail graft in a tongue-in-groove fashion. The FDA-approved femtosecond laser treatments will be performed under topical anesthesia in the laser suite. optical coherence tomography (OCT): OCT will be used to guide the depth of the graft and donor dissections. Topical Anesthesia femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty.	IEK: a. A full thickness graft will be prepared at the eye bank with zigzag side cuts prepared with a femtosecond laser. The graft is separated from the rim, replaced in the preservation medium, and shipped to the surgeon prior to the surgery. b. In the laser suite, the host cornea will be cut with the femtosecond laser with zigzag side cuts leaving a 70-100 micron bridge. A protective eye shield is placed over the eye. The graft will be sutured into the host bed. Retrobulbar Block or General Anesthesia femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty. Eye banks use earlier versions of the Intralase system which are also FDA approved for this indication.
Measure Participants	2	2
Mean (95% Confidence Interval) [logMAR unit]	0.7	0.05

Adverse Events

Time Frame	Data was collected up to 24-months from the date of surgery.
Adverse Event Reporting Description	See data tables for adverse event information.
Arm/Group Title	Laser-assisted Lamellar Anterior Keratoplasty		Intralase-enabled Keratoplasty
Arm/Group Description	LALAK: a. A "dovetail" shaped cut will be made on the graft using a femtosecond laser at the eye bank. The cut depth will be proportional to the central stromal thickness of the graft. This graft will be separated from stromal bed by eye bank personnel for examination of the cut surface. b. The host cornea will receive femtosecond laser cut consisting of a shallow lamellar cut with angled side cut to match the dovetail graft in a tongue-in-groove fashion. The FDA-approved femtosecond laser treatments will be performed under topical anesthesia in the laser suite. optical coherence tomography (OCT): OCT will be used to guide the depth of the graft and donor dissections. Topical Anesthesia femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty.		IEK: a. A full thickness graft will be prepared at the eye bank with zigzag side cuts prepared with a femtosecond laser. The graft is separated from the rim, replaced in the preservation medium, and shipped to the surgeon prior to the surgery. b. In the laser suite, the host cornea will be cut with the femtosecond laser with zigzag side cuts leaving a 70-100 micron bridge. A protective eye shield is placed over the eye. The graft will be sutured into the host bed. Retrobulbar Block or General Anesthesia femtosecond laser: The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty. Eye banks use earlier versions of the Intralase system which are also FDA approved for this indication.
All Cause Mortality
	Laser-assisted Lamellar Anterior Keratoplasty		Intralase-enabled Keratoplasty
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/2 (0%)
Serious Adverse Events
	Laser-assisted Lamellar Anterior Keratoplasty		Intralase-enabled Keratoplasty
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Laser-assisted Lamellar Anterior Keratoplasty		Intralase-enabled Keratoplasty
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/2 (100%)		0/2 (0%)
Eye disorders
Revert to keratoconus pattern	1/2 (50%)	1	0/2 (0%)	0
Corneal epithelial defect with interface haze	1/2 (50%)	1	0/2 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.