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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 because the information has not been verified recently.
Verified April 2009 by Moorfields Eye Hospital NHS Foundation Trust.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Peschke Meditrade, GmbH
Information provided by:
Moorfields Eye Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00890266
First received: April 27, 2009
Last updated: May 6, 2010
Last verified: April 2009
  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.

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890266

Locations
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
Investigators
Principal Investigator: Chad K Rostron, FRCOphth Moorfields Eye Hospital NHS Foundation Trust
  More Information

Additional Information:
Publications:
Hafezi F, Mrochen M, Iseli HP, Seiler T. Collagen cross-linking with ultraviolet-A and hypoosmolar riboflavin solution in thin corneas. J Cataract Refract Surg 2009; 35: 621-624.

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
Pharmaceutical Solutions
Riboflavin
Dermatologic Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Photosensitizing Agents
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on November 20, 2014