Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia

Emory University160 enrolled

Overview

Prospective, randomized, single site study to determine the safety and effectiveness of performing corneal collagen cross-linking (CCCL)using riboflavin and UVA light in eyes with corneal ectasia or progressive keratoconus.

Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. Corneal collagen cross-linking is performed as a single treatment. Subjects are followed for at least 12 months to evaluate the long term effects of corneal collagen cross-linking. Subjects may be referred from other physicians but must return to Emory Vision for completion of all study visits.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Progressive Keratoconus Corneal Ectasia

Interventions

Corneal collagenPROCEDURE

Corneal collagen cross-linking with riboflavin/UVA light

Sham comparatorPROCEDURE

Sham treatment

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of keratoconus with documented progression over the previous 12 months. * Diagnosis of corneal ectasia * Must be able to complete all study visits Exclusion Criteria: * Prior corneal surgery in the keratoconus group * Corneal scarring

Locations (1)

Woolfson Eye Institute

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Change in keratometry

Time frame: 3 Months

Secondary Outcomes

Best spectacle-corrected visual acuity

Time frame: 3 Months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.