Corneal Collagen Cross-linking With Hypotonic Riboflavin in Corneas Thinner Than 400 Microns
HypotonicRibo
Collagen Cross-linking With Riboflavin in a Hypotonic Solution, With UV Light, on Corneas Less Than 400 Microns Thick: an Exploratory Study.
2 other identifiers
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 22, 2009
CompletedFirst Submitted
Initial submission to the registry
April 27, 2009
CompletedFirst Posted
Study publicly available on registry
April 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2010
CompletedApril 12, 2022
April 1, 2022
1 year
April 27, 2009
April 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in keratometry/corneal topography
3 months
Secondary Outcomes (2)
Corneal endothelial cell count
3 months
Visual acuity
3 months
Study Arms (1)
Study Arm
EXPERIMENTALExploratory
Interventions
Topical anaesthesia, corneal epithelial debridement, application of hypotonic riboflavin 0.1% solution (20 minutes), application of UV light (30 minutes).
Eligibility Criteria
You may qualify if:
- Keratoconus
- Corneas thinner than 400 microns, but thicker than 250 microns
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Moorfields Eye Department at St George's Hospital
London, Greater London, SW17 0QT, United Kingdom
Related Publications (1)
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.
PMID: 19304080BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chad K Rostron, FRCOphth
Moorfields Eye Hospital NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2009
First Posted
April 29, 2009
Study Start
April 22, 2009
Primary Completion
April 22, 2010
Study Completion
April 22, 2010
Last Updated
April 12, 2022
Record last verified: 2022-04