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| Sponsor: | Cornea Genetic Eye Institute |
|---|---|
| Information provided by: | Cornea Genetic Eye Institute |
| ClinicalTrials.gov Identifier: | NCT01081561 |
Purpose
This study will determine the efficacy of collagen cross linking for progressive keratoconus and ectasia after lasik. It will try and determine which is a more effective treatment: collagen cross linking alone or collagen cross linking combined with Intacs, a treatment which has already been proven to be effective in decreasing corneal curvature in patients with keratoconus.
| Condition | Intervention | Phase |
|---|---|---|
|
Keratoconus Ectasia |
Drug: Riboflavin |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Study of Corneal Collagen Cross-Linking With the UV-X System for the Treatment of Keratectasia in Eyes With Intacs Compared to Eyes Without Intacs |
| Estimated Enrollment: | 400 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Cross-linking
Corneal collagen cross-linking with riboflavin and UVA light
|
Drug: Riboflavin
Removal of the epithelium, riboflavin drops every 2 minutes for 30 minutes follow by UV light radiation and addition riboflavin drops every 2 minutes for 30 minutes. Some subjects will be randomized to recieve INTACS prior to treatment with riboflavin.
Other Name: Peschke Meditrade
|
|
Active Comparator: Cross-linking plus INTACS
Corneal collagen cross-linking with riboflavin and UVA light plus INTACS
|
Drug: Riboflavin
Removal of the epithelium, riboflavin drops every 2 minutes for 30 minutes follow by UV light radiation and addition riboflavin drops every 2 minutes for 30 minutes. Some subjects will be randomized to recieve INTACS prior to treatment with riboflavin.
Other Name: Peschke Meditrade
|
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Eye Surgery Center of Beverly Hills | Recruiting |
| Beverly Hills, California, United States, 90211 | |
| Contact: Betty Cardenas 310-423-9640 cardenas.b@cshs.org | |
| Contact: Martha Bucaram 310 4239640 bucaramm@cshs.org | |
| Principal Investigator: | Yaron S Rabinowitz, M.D. | Cornea Genetic Eye Institute |
| Principal Investigator: | Ezra Maguen, M.D. | american eye institute |
| Principal Investigator: | Yuri Oleynikov, M.D. PhD | Cornea Genetic Eye Institute |
| Principal Investigator: | James Salz, M.D. | Laser Eye Associates |
More Information
| Responsible Party: | Yaron S. Rabinowitz M.D., Cornea Genetic Eye Institute |
| ClinicalTrials.gov Identifier: | NCT01081561 History of Changes |
| Other Study ID Numbers: | #20090780 |
| Study First Received: | March 4, 2010 |
| Last Updated: | May 12, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Dilatation, Pathologic Keratoconus Pathological Conditions, Anatomical Corneal Diseases Eye Diseases Riboflavin Photosensitizing Agents Radiation-Sensitizing Agents |
Physiological Effects of Drugs Pharmacologic Actions Dermatologic Agents Therapeutic Uses Vitamin B Complex Vitamins Micronutrients Growth Substances |
