Status:
TERMINATED
OCT-guided LALAK for KCN
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Eye Institute (NEI)
Conditions:
Corneal Opacity
Keratoconus
Eligibility:
All Genders
18-100 years
Phase:
NA
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 complica...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2017
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01901614
Start Date
August 1 2013
End Date
August 31 2017
Last Update
January 23 2019
Active Locations (1)
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1
Casey Eye Institute, Oregon Health & Science University
Portland, Oregon, United States, 97239