Corneal Collagen Cross-Linking for Ectasia (CXL)

Glaukos

Status and phase: Completed; Phase 3

Conditions: Ectasia

Treatments: Device: UVA Irradiation; Drug: riboflavin ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00674661

UVX-003

Details and patient eligibility

About

Prospective, randomized multicenter study to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes with ectasia after refractive surgery.

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 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.

Enrollment: 130 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of ectasia after refractive surgery
• Documented ectasia on Pentacam or topography map
• BSCVA worse than 20/20
• Must complete all study visits

Exclusion criteria

• History of delayed wound healing
• History of corneal melt or corneal dystrophy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

130 participants in 2 patient groups

Corneal Collagen Cross-linking (CXL) Treatment Group

Active Comparator group

Description:

riboflavin ophthalmic solution and UVA irradiation

Treatment:

Drug: riboflavin ophthalmic solution

Device: UVA Irradiation

Control Group

Sham Comparator group

Description:

riboflavin opthalmic solution without UVA irradiation

Treatment:

Drug: riboflavin ophthalmic solution