Corneal Collagen Cross-linking With Hypotonic Riboflavin in Corneas Thinner Than 400 Microns (HypotonicRibo)
Recruitment status was Active, not recruiting
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Collagen Cross-linking With Riboflavin in a Hypotonic Solution, With UV Light, on Corneas Less Than 400 Microns Thick: an Exploratory Study.|
- Change in keratometry/corneal topography [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Corneal endothelial cell count [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Visual acuity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||July 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Procedure: Collagen cross-linking with hypotonic riboflavin
When cross-linking corneas of > 400 microns, riboflavin in a solution with high molecular weight dextran T500 is used to prevent corneal swelling during the administration of the drops and the UV treatment. However if riboflavin is applied to a cornea in a hypotonic solution (saline), then transient corneal oedema is created with thickening of the corneal stroma. In this way it is thought that the temporarily thickened cornea can be treated with UV whilst still providing a sufficient thickness to absorb the UV to an extent that endothelial cell damage is avoided.
Please refer to this study by its ClinicalTrials.gov identifier: 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|