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

U

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

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.

Trial contacts and locations

1

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Central trial contact

Ricardo Lamy, MD

Data sourced from clinicaltrials.gov

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