Riboflavin-UVA Induced Collagen Crosslinking Treatment for Corneal Ectasia - Full Text View

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:

Drug Information available for: Riboflavin

Genetic and Rare Diseases Information Center resources: Keratoconus

U.S. FDA Resources

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:

riboflavin-

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-

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 (Adult, Senior)
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:

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.

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.


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 Photosensitizing Agents Dermatologic Agents

ClinicalTrials.gov processed this record on September 30, 2016