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

Primary Purpose

Keratoconus

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Collagen cross-linking with hypotonic riboflavin
Sponsored by
Moorfields Eye Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Keratoconus focused on measuring keratoconus, collagen cross-linking, riboflavin, UV light

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Moorfields Eye Department at St George's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Arm

Arm Description

Exploratory

Outcomes

Primary Outcome Measures

Change in keratometry/corneal topography

Secondary Outcome Measures

Corneal endothelial cell count
Visual acuity

Full Information

First Posted
April 27, 2009
Last Updated
April 4, 2022
Sponsor
Moorfields Eye Hospital NHS Foundation Trust
Collaborators
Peschke Meditrade, GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00890266
Brief Title
Corneal Collagen Cross-linking With Hypotonic Riboflavin in Corneas Thinner Than 400 Microns
Acronym
HypotonicRibo
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 Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 22, 2009 (Actual)
Primary Completion Date
April 22, 2010 (Actual)
Study Completion Date
April 22, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moorfields Eye Hospital NHS Foundation Trust
Collaborators
Peschke Meditrade, GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
keratoconus, collagen cross-linking, riboflavin, UV light

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Arm
Arm Type
Experimental
Arm Description
Exploratory
Intervention Type
Procedure
Intervention Name(s)
Collagen cross-linking with hypotonic riboflavin
Other Intervention Name(s)
Medio-Cross® hypotonic solution
Intervention Description
Topical anaesthesia, corneal epithelial debridement, application of hypotonic riboflavin 0.1% solution (20 minutes), application of UV light (30 minutes).
Primary Outcome Measure Information:
Title
Change in keratometry/corneal topography
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Corneal endothelial cell count
Time Frame
3 months
Title
Visual acuity
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chad K Rostron, FRCOphth
Organizational Affiliation
Moorfields Eye Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moorfields Eye Department at St George's Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19304080
Citation
Hafezi F, Mrochen M, Iseli HP, Seiler T. Collagen crosslinking with ultraviolet-A and hypoosmolar riboflavin solution in thin corneas. J Cataract Refract Surg. 2009 Apr;35(4):621-4. doi: 10.1016/j.jcrs.2008.10.060.
Results Reference
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Corneal Collagen Cross-linking With Hypotonic Riboflavin in Corneas Thinner Than 400 Microns

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