Collagen Cross-Linking for Keratoconus/Ectasia With and Without Intacs
This study is currently recruiting participants.
Verified December 2012 by Cornea Genetic Eye Institute
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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| First Received Date ICMJE | March 4, 2010 | ||||||||||||||||||||
| Last Updated Date | December 17, 2012 | ||||||||||||||||||||
| Start Date ICMJE | June 2009 | ||||||||||||||||||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Effectiveness of UV-X cross linking to halt progression of keratoconus [ Time Frame: 5 years ] [ Designated as safety issue: No ] | ||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT01081561 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | Collagen Cross-Linking for Keratoconus/Ectasia With and Without Intacs | ||||||||||||||||||||
| Official Title ICMJE | 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 | ||||||||||||||||||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||||||
| Estimated Enrollment ICMJE | 400 | ||||||||||||||||||||
| Estimated Completion Date | June 2015 | ||||||||||||||||||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||
| Ages | 21 Years to 65 Years | ||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||
| Contacts ICMJE | Not Provided | ||||||||||||||||||||
| Location Countries ICMJE | United States | ||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT Number ICMJE | NCT01081561 | ||||||||||||||||||||
| Other Study ID Numbers ICMJE | #20090780 | ||||||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||||||
| Responsible Party | Yaron S. Rabinowitz M.D., Cornea Genetic Eye Institute | ||||||||||||||||||||
| Study Sponsor ICMJE | Yaron S. Rabinowitz M.D. | ||||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Cornea Genetic Eye Institute | ||||||||||||||||||||
| Verification Date | December 2012 | ||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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