Corneal Collagen Cross-linking for Progressive Keratoconus (CXL)

Glaukos

Status and phase: Completed; Phase 3

Conditions: Progressive Keratoconus

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00647699

UVX-002

Details and patient eligibility

About

Prospective, randomized multicenter study to determine the safety and effectiveness of performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with progressive keratoconus.

Full description

This was a sham controlled study for the first three months. Patients had one eye designated as the study eye and were randomized to receive one of two study treatments (CXL or sham) in their study eye. The patients were evaluated at 1, 3, 6, and 12 months. At month 3 or later patients had the option of receiving CXL treatment in both the sham and non-study eye.

Enrollment: 147 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of keratoconus
• Documented progression over previous 24 months
• Decreased BSCVA
• Must complete all study visits

Exclusion criteria

• Prior corneal surgery or Intacs
• History of delayed wound healing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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147 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 ophthalmic solution without UVA irradiation.

Treatment:

Drug: riboflavin ophthalmic solution