Corneal Collagen Cross-linking With Hypotonic Riboflavin in Corneas Thinner Than 400 Microns (HypotonicRibo)
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Purpose
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 | Intervention |
|---|---|
|
Keratoconus |
Procedure: Collagen cross-linking with hypotonic riboflavin |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 5 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | July 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom | |
| 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | Mr Chad K Rostron, Moorfields Eye Department at St. George's Hospital. |
| ClinicalTrials.gov Identifier: | NCT00890266 History of Changes |
| Other Study ID Numbers: | CHAR1006, 08/H0721/15 |
| Study First Received: | April 27, 2009 |
| Last Updated: | May 6, 2010 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Moorfields Eye Hospital NHS Foundation Trust:
|
keratoconus collagen cross-linking riboflavin UV light |
Additional relevant MeSH terms:
|
Keratoconus Corneal Diseases Eye Diseases Riboflavin Photosensitizing Agents Radiation-Sensitizing Agents Physiological Effects of Drugs |
Pharmacologic Actions Dermatologic Agents Therapeutic Uses Vitamin B Complex Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 19, 2013