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

Emory University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Progressive Keratoconus; Corneal Ectasia

Treatments: Procedure: Corneal collagen; Procedure: Sham comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT00567671

UVX-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Treatment

Experimental group

Description:

Corneal collagen cross-linking

Treatment:

Procedure: Corneal collagen

Control

Sham Comparator group

Description:

Sham Treatment

Treatment:

Procedure: Sham comparator