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

Keratoconus Clinical Trial

— HypotonicRibo  

Official title:

Collagen Cross-linking With Riboflavin in a Hypotonic Solution, With UV Light, on Corneas Less Than 400 Microns Thick: an Exploratory Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890266
• Other study ID #: CHAR1006
• Secondary ID: 08/H0721/15
• Status: Completed
• Phase: N/A
• Start date: April 22, 2009
• Est. completion date: April 22, 2010

Study information

• Verified date: April 2022
• Source: Moorfields Eye Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 22, 2010
• Est. primary completion date: April 22, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

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).

Locations

Country	Name	City	State
United Kingdom	Moorfields Eye Department at St George's Hospital	London	Greater London

Sponsors (2)

Lead Sponsor	Collaborator
Moorfields Eye Hospital NHS Foundation Trust	Peschke Meditrade, GmbH

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in keratometry/corneal topography		3 months
Secondary	Corneal endothelial cell count		3 months
Secondary	Visual acuity		3 months