Riboflavin-UVA Induced Collagen Crosslinking Treatment for Corneal Ectasia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Singapore National Eye Centre.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT01123057
First received: May 10, 2010
Last updated: May 13, 2010
Last verified: May 2010
  Purpose

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


Condition Intervention
Corneal Ectasia
Procedure: riboflavin-induced collagen cross-linking treatment
Device: Riboflavin-UVA induced collagen cross-linking treatment for corneal ectasia

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Riboflavin-UVA Induced Collagen Crosslinking Treatment for Corneal Ectasia

Resource links provided by NLM:


Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:
  • corneal topography [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The keratometry values will be monitored.


Secondary Outcome Measures:
  • visual acuity [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: riboflavin-induced collagen cross-linking treatment

    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.

    Device: Riboflavin-UVA induced collagen cross-linking treatment for corneal ectasia
    Use of riboflavin eyedrops during the procedure Use of UVA device (Peschke Meditrade)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01123057

Locations
Singapore
Singapore Eye Research Institute Recruiting
Singapore, Singapore, 168751
Contact: Yeng Li Goh    6563224533      
Principal Investigator: Li Lim, FRCS         
Sponsors and Collaborators
Singapore National Eye Centre
Investigators
Principal Investigator: Li Lim Singapore National Eye Centre
  More Information

Publications:
Responsible Party: Lim Li, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT01123057     History of Changes
Other Study ID Numbers: R573/61/2007
Study First Received: May 10, 2010
Last Updated: May 13, 2010
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Singapore National Eye Centre:
keratoconus
collagen cross-linking
LASIK ectasia
keratoconus,lasik ectasia

Additional relevant MeSH terms:
Riboflavin
Dilatation, Pathologic
Corneal Diseases
Pathological Conditions, Anatomical
Eye Diseases
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 19, 2014