Corneal Collagen Cross-linking With Hypotonic Riboflavin in Corneas Thinner Than 400 Microns (HypotonicRibo)
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|ClinicalTrials.gov Identifier: NCT00890266|
Recruitment Status : Unknown
Verified April 2009 by Moorfields Eye Hospital NHS Foundation Trust.
Recruitment status was: Active, not recruiting
First Posted : April 29, 2009
Last Update Posted : May 7, 2010
Corneal ectasia is a relative weakness in the structure of the cornea, which produces a progressive change in its shape which results in visual distortion. It is known that collagen cross-linking in the cornea occurs naturally with age, and in diabetes, both of which seem to prevent progressive ectasia. Corneal collagen cross-linking with riboflavin on corneas thicker than 400 microns has been shown to stabilize the cornea in keratoconus, and prevent progression of the disease.
The purpose of this study is to determine whether corneal collagen cross-linking with riboflavin in a hypotonic solution, with UV light, on corneas less than 400 microns thick, leads to stabilisation of corneal ectasia.
|Condition or disease||Intervention/treatment||Phase|
|Keratoconus||Procedure: Collagen cross-linking with hypotonic riboflavin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Collagen Cross-linking With Riboflavin in a Hypotonic Solution, With UV Light, on Corneas Less Than 400 Microns Thick: an Exploratory Study.|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||April 2010|
|Estimated Study Completion Date :||July 2010|
- Procedure: Collagen cross-linking with hypotonic riboflavin
Topical anaesthesia, corneal epithelial debridement, application of hypotonic riboflavin 0.1% solution (20 minutes), application of UV light (30 minutes).Other Name: Medio-Cross® hypotonic solution
- Change in keratometry/corneal topography [ Time Frame: 3 months ]
- Corneal endothelial cell count [ Time Frame: 3 months ]
- Visual acuity [ Time Frame: 3 months ]
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): NCT00890266
|Moorfields Eye Department at St George's Hospital|
|London, Greater London, United Kingdom, SW17 0QT|
|Principal Investigator:||Chad K Rostron, FRCOphth||Moorfields Eye Hospital NHS Foundation Trust|