Collagen Cross-Linking for Keratoconus/Ectasia With and Without Intacs
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2012 by Cornea Genetic Eye Institute.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Yaron S. Rabinowitz M.D.
Information provided by (Responsible Party):
Yaron S. Rabinowitz M.D., Cornea Genetic Eye Institute
ClinicalTrials.gov Identifier:
NCT01081561
First received: March 4, 2010
Last updated: December 17, 2012
Last verified: December 2012
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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 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 |
Resource links provided by NLM:
Further study details as provided by Cornea Genetic Eye Institute:
Primary Outcome Measures:
- Effectiveness of UV-X cross linking to halt progression of keratoconus [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determine whether UV-X treatment is more effective when combined with Intacs or just UV-X alone [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| 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 (Adult) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081561
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | March 4, 2010 |
| Last Updated: | December 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Riboflavin Keratoconus Dilatation, Pathologic Corneal Diseases Eye Diseases Pathological Conditions, Anatomical Vitamin B Complex |
Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Photosensitizing Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on September 28, 2016