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Completed

NCT Number: NCT00890266

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

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.

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moorfields Eye Department at St George's Hospital

London, Greater London, SW17 0QT, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collagen cross-linking with hypotonic riboflavin

Procedure

Topical anaesthesia, corneal epithelial debridement, application of hypotonic riboflavin 0.1% solution (20 minutes), application of UV light (30 minutes).

Other names: Medio-Cross® hypotonic solution

Primary outcomes

  1. Change in keratometry/corneal topography

    Time frame: 3 months

Secondary outcomes

  1. Corneal endothelial cell count

    Time frame: 3 months

  2. Visual acuity

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust

Other

Collaborators

  • Peschke Meditrade, GmbH

Registry information

Official study title

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

Acronym: HypotonicRibo

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 29, 2009
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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