Status:
COMPLETED
Corneal Crosslinking in Patients With Keratoconus and Post-Refractive Ectasia
Lead Sponsor:
Price Vision Group
Conditions:
Keratoconus
Post-Refractive Ectasia
Eligibility:
All Genders
10+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effectiveness of using riboflavin and UV light to treat progressive keratoconus or post-refractive corneal ectasia.
Detailed Description
The primary objective of this study is to evaluate two riboflavin-dosing regimens for corneal collagen cross-linking to slow the progressive changes in corneal curvature in eyes with progressive kerat...
Eligibility Criteria
Inclusion
- 10 years of age or older
- Having documented ectasia on topography or tomography after previous refractive surgery OR progressive keratoconus defined as one or more of the following changes over a period of 36 months or less before randomization:
- An increase of ≥ 1.00 D in the steepest keratometry value (or sim K)
- An increase of ≥ 1.00 D in regular astigmatism evaluated by subjective manifest refraction
- A myopic shift (decrease in the spherical equivalent) of ≥ 0.50 D on subjective manifest refraction
- Documented decrease in visual acuity associated with irregular astigmatism and topographic features of ectasia.
- Subjects with keratoconus diagnosis only:
- a. Axial topography consistent with keratoconus b. Presence of central or inferior steepening on the Pentacam map. c. Presence of one or more slit lamp findings associated with keratoconus, such as: i. Fleischer ring ii. Vogt striae iii. Corneal thinning iv. Corneal scarring
- Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction:
- Contact Lens Type Minimum Discontinuation Time Soft 3 Days Soft Extended Wear 1 Week Soft Toric 2 Weeks Rigid gas permeable 2 Weeks
- Signed written informed consent
Exclusion
- 1\. Any keratoconus patient over 21 years of age without evidence of progression of his corneal deformity.
- 2\. Patients with excessively thin corneas. 3. Previous ocular condition in the eyes to be treated that may predispose the eye for future complications, for example:
- a. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) b. Clinically significant corneal scarring in the proposed treatment zone 4. A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
- 5\. A known sensitivity to treatment medications. 6. Patients with a current condition that, in the treating physician's opinion, would interfere with or prolong epithelial healing.
- 7\. Pregnancy (including plan to become pregnant) or lactation during the course of the study
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2017
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT01143389
Start Date
May 1 2010
End Date
August 30 2017
Last Update
June 6 2018
Active Locations (1)
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1
Price Vision Group
Indianapolis, Indiana, United States, 46260