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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2009 by Moorfields Eye Hospital NHS Foundation Trust.
Recruitment status was:  Active, not recruiting
Peschke Meditrade, GmbH
Information provided by:
Moorfields Eye Hospital NHS Foundation Trust Identifier:
First received: April 27, 2009
Last updated: May 6, 2010
Last verified: April 2009

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: Intervention Model: Single Group Assignment
Masking: None (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.

Resource links provided by NLM:

Further study details as provided by Moorfields Eye Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • Change in keratometry/corneal topography [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Corneal endothelial cell count [ Time Frame: 3 months ]
  • Visual acuity [ Time Frame: 3 months ]

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)
Intervention Details:
    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).
    Other Name: Medio-Cross® hypotonic solution
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.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT00890266

United Kingdom
Moorfields Eye Department at St George's Hospital
London, Greater London, United Kingdom, SW17 0QT
Sponsors and Collaborators
Moorfields Eye Hospital NHS Foundation Trust
Peschke Meditrade, GmbH
Principal Investigator: Chad K Rostron, FRCOphth Moorfields Eye Hospital NHS Foundation Trust
  More Information

Additional Information:
Responsible Party: Mr Chad K Rostron, Moorfields Eye Department at St. George's Hospital. Identifier: NCT00890266     History of Changes
Other Study ID Numbers: CHAR1006
Study First Received: April 27, 2009
Last Updated: May 6, 2010

Keywords provided by Moorfields Eye Hospital NHS Foundation Trust:
collagen cross-linking
UV light

Additional relevant MeSH terms:
Corneal Diseases
Eye Diseases
Pharmaceutical Solutions
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents processed this record on September 21, 2017