Riboflavin-UVA Induced Collagen Crosslinking Treatment for Corneal Ectasia

NCT01123057 | Unknown

• 1 other identifier: R573/61/2007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Corneal Ectasia

Keywords

keratoconus; collagen cross-linking; LASIK ectasia; keratoconus,lasik ectasia

Outcome Measures

Primary Outcomes (1)

• corneal topography

  The keratometry values will be monitored.

  1 year

Secondary Outcomes (1)

• visual acuity

  1 year

Interventions

riboflavin-induced collagen cross-linking treatment PROCEDURE

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.

Riboflavin-UVA induced collagen cross-linking treatment for corneal ectasia DEVICE

Use of riboflavin eyedrops during the procedure Use of UVA device (Peschke Meditrade)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Singapore National Eye Centre: lead

Study Sites (1)

Singapore Eye Research Institute

Singapore, Singapore, 168751, Singapore

RECRUITING

Related Publications (2)

• Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7. doi: 10.1016/s0002-9394(02)02220-1.

  PMID: 12719068 BACKGROUND

• Caporossi A, Mazzotta C, Baiocchi S, Caporossi T. Long-term results of riboflavin ultraviolet a corneal collagen cross-linking for keratoconus in Italy: the Siena eye cross study. Am J Ophthalmol. 2010 Apr;149(4):585-93. doi: 10.1016/j.ajo.2009.10.021. Epub 2010 Feb 6.

  PMID: 20138607 BACKGROUND

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Li Lim

  Singapore National Eye Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 14, 2010
• Study Start: August 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 14, 2010

Record last verified: 2010-05

Locations

SG (1)