Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study

N/AUnknownNCT00642044

Universidade Federal do Rio de Janeiro100 enrolled

Overview

Cross-linking of the cornea increases the mechanical and biochemical stability of the stromal tissue. The purpose of this study is to assess the effectiveness of riboflavin-ultraviolet light induced cross-linking of corneal collagen in improving visual acuity and reducing progression of keratoconus in the Brazilian population.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Keratoconus

Interventions

Corneal Collagen CrosslinkingPROCEDURE

UV light and Riboflavin eyedrops every 5 minutes for 30 minutes.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age from 18 to 35 years. * Diagnosis of Keratoconus. * Progression of Ametropia. * Written informed consent. Exclusion Criteria: * Corneal Thickness \< 395 micra at thinnest point. * Other active ocular disease than keratectasia. * Cornea Guttata. * Previous ocular surgery. * Pregnancy. * Known sensitivity to riboflavin.

Locations (1)

Clementino Fraga Filho University Hospital

Rio de Janeiro, Rio de Janeiro, Brazil

RECRUITING

Outcomes

Primary Outcomes

Keratometry

Time frame: 3 months

BSCVA (Best spectacle corrected visual acuity)

Time frame: 3 months

Secondary Outcomes

Endothelial cell count

Time frame: 3 months

Central Contacts

Ricardo Lamy, MD

CONTACT

55-21-2714-7646 lamy@ufrj.br

Data from ClinicalTrials.gov

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