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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00890266
Recruitment Status : Unknown
Verified April 2009 by Moorfields Eye Hospital NHS Foundation Trust.
Recruitment status was:  Active, not recruiting
First Posted : April 29, 2009
Last Update Posted : May 7, 2010
Peschke Meditrade, GmbH
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Keratoconus Procedure: Collagen cross-linking with hypotonic riboflavin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
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.
Study Start Date : April 2009
Actual Primary Completion Date : April 2010
Estimated Study Completion Date : July 2010

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

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

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00890266

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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
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Principal Investigator: Chad K Rostron, FRCOphth Moorfields Eye Hospital NHS Foundation Trust
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Responsible Party: Mr Chad K Rostron, Moorfields Eye Department at St. George's Hospital. Identifier: NCT00890266    
Other Study ID Numbers: CHAR1006
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: May 7, 2010
Last Verified: April 2009
Keywords provided by Moorfields Eye Hospital NHS Foundation Trust:
collagen cross-linking
UV light
Additional relevant MeSH terms:
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Corneal Diseases
Eye Diseases
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents