Corneal Collagen Cross-linking With Hypotonic Riboflavin in Corneas Thinner Than 400 Microns

Not Applicable

Completed

• Conditions: Keratoconus
• Interventions: Procedure: Collagen cross-linking with hypotonic riboflavin

• Registration Number: NCT00890266
• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-04-22
• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Primary Completion: 2010-04-22
• Study Completion: 2010-04-22
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Keratoconus
• Corneas thinner than 400 microns, but thicker than 250 microns

Exclusion Criteria

• Evidence of other corneal disease in the eye to be treated (e.g., Herpes simplex keratitis)
• Women who are pregnant or nursing at the time of the initial treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Arm	Collagen cross-linking with hypotonic riboflavin	Exploratory

Primary Outcome Measures

Name	Time	Method
Change in keratometry/corneal topography	3 months

Secondary Outcome Measures

Name	Time	Method
Corneal endothelial cell count	3 months
Visual acuity	3 months

Trial Locations

Locations (1)

Moorfields Eye Department at St George's Hospital; 🇬🇧 London, Greater London, United Kingdom