Collagen Cross-Linking for Keratoconus/Ectasia With and Without Intacs
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Yaron S. Rabinowitz M.D., Cornea Genetic Eye Institute.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Yaron S. Rabinowitz M.D.
ClinicalTrials.gov Identifier:
NCT01081561
First Posted: March 5, 2010
Last Update Posted: December 18, 2012
Information provided by (Responsible Party):
Yaron S. Rabinowitz M.D., Cornea Genetic Eye Institute
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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 Intervention Model: Parallel Assignment Masking: None (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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
keratoconus
Drug Information available for:
Riboflavin
U.S. FDA Resources
Further study details as provided by Yaron S. Rabinowitz M.D., Cornea Genetic Eye Institute:
Primary Outcome Measures:
- Effectiveness of UV-X cross linking to halt progression of keratoconus [ Time Frame: 5 years ]
Secondary Outcome Measures:
- Determine whether UV-X treatment is more effective when combined with Intacs or just UV-X alone [ Time Frame: 5 years ]
| 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 21 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- progressive keratoconus or ectasia
Exclusion Criteria:
- cornea thinner than 400um
- K readings greater than 60D
- Central corneal scarring
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081561
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 | |
Sponsors and Collaborators
Yaron S. Rabinowitz M.D.
Investigators
| 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 |
| Principal Investigator: | Ronald Gaster, MD | Cornea Eye Institute, Beverly Hills |
More Information
| Responsible Party: | Yaron S. Rabinowitz M.D., Yaron S Rabinowitz M.D., Cornea Genetic Eye Institute |
| ClinicalTrials.gov Identifier: | NCT01081561 History of Changes |
| Other Study ID Numbers: |
#20090780 |
| First Submitted: | March 4, 2010 |
| First Posted: | March 5, 2010 |
| Last Update Posted: | December 18, 2012 |
| Last Verified: | December 2012 |
Additional relevant MeSH terms:
|
Keratoconus Dilatation, Pathologic Corneal Diseases Eye Diseases Pathological Conditions, Anatomical Riboflavin Vitamin B Complex |
Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Photosensitizing Agents Dermatologic Agents |