OCT-guided LALAK for KCN
Primary Purpose
Corneal Opacity, Keratoconus
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LALAK
IEK
Retrobulbar Block or General Anesthesia
optical coherence tomography (OCT)
Topical Anesthesia
femtosecond laser
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Opacity focused on measuring Keratoconus, Corneal Opacity, Keratoplasty
Eligibility Criteria
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:
- Preoperative corneal thickness less than 400 microns.
- Corneal edema
- Central guttata
- Inability to give informed consent.
- Inability to maintain stable fixation for OCT imaging.
- Inability to commit to required visits to complete the study.
- Eyes with concurrent cataract, retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery.
- Patients with severe collagen vascular diseases or ocular surface disorders
Sites / Locations
- Casey Eye Institute, Oregon Health & Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LALAK
IEK
Arm Description
laser-assisted lamellar anterior keratoplasty. Optical Coherence Tomography, femtosecond laser, topical anesthesia, and Retrobulbar Block or General Anesthesia will be used.
Intralase-enabled keratoplasty. Femtosecond laser and Retrobulbar Block or General Anesthesia will be used.
Outcomes
Primary Outcome Measures
Does LALAK Achieve the Same Level of Post-operative BSCVA as IEK.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01901614
First Posted
July 2, 2013
Last Updated
January 16, 2019
Sponsor
Oregon Health and Science University
Collaborators
National Institutes of Health (NIH), National Eye Institute (NEI)
1. Study Identification
Unique Protocol Identification Number
NCT01901614
Brief Title
OCT-guided LALAK for KCN
Official Title
RANDOMIZED CLINICAL TRIAL OF OCT-GUIDED LASER-ASSISTED LAMELLAR ANTERIOR KERATOPLASTY IN ADULTS FOR KERATOCONUS
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Modifying procedure
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
August 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
National Institutes of Health (NIH), National Eye Institute (NEI)
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Opacity, Keratoconus
Keywords
Keratoconus, Corneal Opacity, Keratoplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LALAK
Arm Type
Experimental
Arm Description
laser-assisted lamellar anterior keratoplasty. Optical Coherence Tomography, femtosecond laser, topical anesthesia, and Retrobulbar Block or General Anesthesia will be used.
Arm Title
IEK
Arm Type
Active Comparator
Arm Description
Intralase-enabled keratoplasty. Femtosecond laser and Retrobulbar Block or General Anesthesia will be used.
Intervention Type
Procedure
Intervention Name(s)
LALAK
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
IEK
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Retrobulbar Block or General Anesthesia
Intervention Type
Device
Intervention Name(s)
optical coherence tomography (OCT)
Intervention Description
OCT will be used to guide the depth of the graft and donor dissections.
Intervention Type
Drug
Intervention Name(s)
Topical Anesthesia
Intervention Type
Device
Intervention Name(s)
femtosecond laser
Intervention Description
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.
Primary Outcome Measure Information:
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Preoperative corneal thickness less than 400 microns.
Corneal edema
Central guttata
Inability to give informed consent.
Inability to maintain stable fixation for OCT imaging.
Inability to commit to required visits to complete the study.
Eyes with concurrent cataract, retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery.
Patients with severe collagen vascular diseases or ocular surface disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winston Chamberlain, MD, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Casey Eye Institute, Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.coollab.net
Description
Related Info
Learn more about this trial
OCT-guided LALAK for KCN
We'll reach out to this number within 24 hrs