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

NCT ID: NCT00890266

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-22
• Study Completion Date: 2010-04-22

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.

Conditions

Keratoconus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Study Arm

Exploratory

Group Type: EXPERIMENTAL

Collagen cross-linking with hypotonic riboflavin

Intervention Type: PROCEDURE

Topical anaesthesia, corneal epithelial debridement, application of hypotonic riboflavin 0.1% solution (20 minutes), application of UV light (30 minutes).

Interventions

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).

Intervention Type: PROCEDURE

Other Intervention Names

Medio-Cross® hypotonic solution

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peschke Meditrade, GmbH

INDUSTRY

Sponsor Role: collaborator

Moorfields Eye Hospital NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chad K Rostron, FRCOphth

Role: PRINCIPAL_INVESTIGATOR

Moorfields Eye Hospital NHS Foundation Trust

Locations

Moorfields Eye Department at St George's Hospital

London, Greater London, United Kingdom

Countries

United Kingdom

References

Hafezi F, Mrochen M, Iseli HP, Seiler T. Collagen crosslinking with ultraviolet-A and hypoosmolar riboflavin solution in thin corneas. J Cataract Refract Surg. 2009 Apr;35(4):621-4. doi: 10.1016/j.jcrs.2008.10.060.

Reference Type: BACKGROUND

PMID: 19304080 (View on PubMed)

Other Identifiers

08/H0721/15

Identifier Type: -

Identifier Source: secondary_id

CHAR1006

Identifier Type: -

Identifier Source: org_study_id