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

Universidade Federal do Rio de Janeiro

Status: Unknown

Conditions: Keratoconus

Treatments: Procedure: Corneal Collagen Crosslinking

Study type: Interventional

Funder types: Other

Identifiers

NCT00642044

005/07-CEP

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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100 participants in 2 patient groups

A

Experimental group

Description:

The eye with the worst visual acuity receives the treatment. (the other eye serve as control).

Treatment:

Procedure: Corneal Collagen Crosslinking

B

No Intervention group

Description:

The eye with the best visual acuity do not receive the treatment.