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Riboflavin-UVA Induced Collagen Crosslinking Treatment for Corneal Ectasia

2014-08-27 03:13:41 | BioPortfolio

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

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 Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Corneal Ectasia

Intervention

riboflavin-induced collagen cross-linking treatment, Riboflavin-UVA induced collagen cross-linking treatment for corneal ectasia

Location

Singapore Eye Research Institute
Singapore
Singapore
168751

Status

Recruiting

Source

Singapore National Eye Centre

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:41-0400

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Medical and Biotech [MESH] Definitions

An enzyme that catalyzes the formation of riboflavin from two molecules of 6,7-dimethyl-8-ribityllumazine, utilizing a four-carbon fragment from one molecule which is transferred to the second molecule. EC 2.5.1.9.

A dietary deficiency of riboflavin causing a syndrome chiefly marked by cheilitis, angular stomatitis, glossitis associated with a purplish red or magenta-colored tongue that may show fissures, corneal vascularization, dyssebacia, and anemia. (Dorland, 27th ed)

Abnormally high temperature intentionally induced in living things regionally or whole body. It is most often induced by radiation (heat waves, infra-red), ultrasound, or drugs.

Artificially induced UTERINE CONTRACTION. Generally, LABOR, OBSTETRIC is induced with the intent to cause delivery of the fetus and termination of pregnancy.

A coenzyme for a number of oxidative enzymes including NADH DEHYDROGENASE. It is the principal form in which RIBOFLAVIN is found in cells and tissues.

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