Riboflavin-UVA Induced Collagen Crosslinking Treatment for Corneal Ectasia

May 13, 2010 updated by: Singapore National Eye Centre
This is a hospital-based interventional prospective study. Patients with clinical keratoconus or LASIK keratectasia presenting to the Singapore National Eye Centre who meet the eligibility criteria are recruited for this study. The aim of the study is to assess the safety and efficacy of riboflavin-UVA induced cross-linking treatment for corneal ectasia

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of this evaluation is to assess the safety and efficacy of riboflavin-UVA induced cross-linking treatment for corneal ectasia due to keratoconus and LASIK keratectasia. The principle of the procedure is to induce collagen crosslinking of the corneal stroma by the using riboflavin/UVA-treatment.

The technique involves topical application of riboflavin/dextran solution onto eye after removal of corneal epithelium. After initial riboflavin application for 30 minutes, UVA light is shone onto the cornea for another 30 minutes with continued topical riboflavin application.

A thorough examination is performed to evaluate the following pre-operatively:

  • Manifest refraction results - Uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA)
  • Cycloplegic refraction results - Uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA)
  • Slit-lamp biomicroscopy and photography
  • Intraocular pressure measurement
  • Fundoscopy
  • Corneal topography using Orbscan II and Pentacam
  • Corneal aberrometry measurement using Technolas Zywave Aberrometer
  • Endothelial cell count measurement using Konan noncontact endothelial cell analyser
  • Confocal microscopy
  • Corneal hysteresis measurement using Ocular Response Analyser
  • Subjective feedback about quality of vision (VF 14 assessment) Post-operative Assessment (1 day, 1 week, 1 month, 3 months, 6 months and 1 year postoperatively)
  • Uncorrected visual acuity and best corrected visual acuity with manifest refraction
  • Cycloplegic refraction results - uncorrected visual acuity and best corrected visual acuity
  • Subjective visual outcome rating
  • Slit lamp examination and photography
  • Fundoscopy
  • Corneal topography
  • Aberrometry measurement
  • Endothelial cell count
  • Confocal microscopy
  • Corneal hysteresis measurement
  • Report adverse events

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 168751
        • Recruiting
        • Singapore Eye Research Institute
        • Contact:
          • Yeng Li Goh
          • Phone Number: 6563224533
        • Principal Investigator:
          • Li Lim, FRCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have clinical evidence of keratoconus or LASIK keratectasia (moderate to severe)
  • Visual acuity with contact lenses must be better than or equal to 6/12 (20/40).
  • Patients must be intolerant of contact lenses, i.e., they must be unable to wear contact lenses for a whole day.
  • Patients should have a minimum of corneal thickness of 400um (with cornea at swollen state denuded of epithelium during surgery).
  • In terms of general health, patients must not have any illnesses posing an immediate threat to life.
  • Patients must over 18 years of age.
  • Patients' contact lens wear must be stopped 3 days prior to preop assessment
  • Patients can wear their lenses up to the day before the surgery
  • Any vitamin C intake must be stopped 1 week prior to surgery
  • Both eyes may be recruited if eligible.
  • Patients with other non-inflammatory corneal thinning disorders such as pellucid marginal degeneration, keratoglobus and posterior keratoconus may be recruited

Exclusion Criteria:

  • corneal thickness <400 µm in swollen state
  • epithelial healing disorders (e.g. map-dot-fingerprint dystrophy, rheumatic disorders)
  • refractive keratotomies
  • corneal melting conditions
  • herpes keratitis (UV can activate this herpes virus)
  • associated systemic disorder such as Down's syndrome
  • Pregnancy
  • Breast-feeding.
  • Patients with history of herpetic keratitis.
  • Patients with autoimmune diseases
  • Patients with IOP >21mmHg
  • Patients with cataracts
  • Patients taking part in other biomedical research in the 30 days prior to the start of this study.
  • Patients with alcohol abuse, psychological weakness, or an uncooperative disposition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
corneal topography
Time Frame: 1 year
The keratometry values will be monitored.
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
visual acuity
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore National Eye Centre

Investigators

  • Principal Investigator: Li Lim, Singapore National Eye Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

May 10, 2010

First Submitted That Met QC Criteria

May 13, 2010

First Posted (Estimate)

May 14, 2010

Study Record Updates

Last Update Posted (Estimate)

May 14, 2010

Last Update Submitted That Met QC Criteria

May 13, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R573/61/2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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