Status:
UNKNOWN
Treatment of Keratoconus Using Collagen Cross-Linking
Lead Sponsor:
University at Buffalo
Conditions:
Keratoconus
Eligibility:
All Genders
16-35 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine the effectiveness of collagen cross-linking in the cornea in halting the progression and possibly partially reversing the effects of keratoconus. Keratoconus ...
Detailed Description
The goal is for two groups of approximately 66 patients to be included in the study. One eye from the first group will undergo treatment, while the second group of age matched individuals will serve a...
Eligibility Criteria
Inclusion
- no prior history of ocular surgery
- treatment eye must have a maximum corneal power of between 47 D and 60 diopters
- corneal thickness must be greater than 400 µ
- absence of corneal scarring
- patients must meet the diagnostic criteria for keratoconus, which include one or more of the following features:
- high myopia
- corneal ectasia as viewed by slit-lamp exam or measured by pachometry
- Vogt's striae
- topographic findings of superior flattening and inferior steepening of the cornea
- presence of Fleischer ring
Exclusion
- history of prior ocular surgery (history of contact lens use is not an exclusion criterion)
- average corneal power \> 60 D
- presence of corneal scarring
- corneal thickness 400 µ or less
- history of herpes simplex virus keratitis
- history of uveitis
- pre-existing glaucoma
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00841386
Start Date
September 1 2008
End Date
December 1 2011
Last Update
February 11 2009
Active Locations (2)
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1
Fichte,Endl, & Elmer EyeCare
Amherst, New York, United States, 14228
2
The Ira G. Ross Eye Institute
Buffalo, New York, United States, 14209