Safety Study of the VEGA UV-A System to Treat Keratoconus

Topcon

Status and phase: Terminated; Phase 3

Conditions: Keratoconus

Treatments: Drug: Riboflavin; Device: The VEGA UV-A Illumination System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01190306

CXL-001

Details and patient eligibility

About

The purpose of this research study is to test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL), when used to treat keratoconus.

Enrollment: 127 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 12 years of age or older
• Having a diagnosis of keratoconus
• Presence of central or inferior steepening
• Topography consistent with keratoconus
• Presence of one or more slit lamp or retinoscopy findings associated with keratoconus
• Contact lens wearers only:Removal of contact lenses for the required period of time
• Signed written informed consent
• Willingness and ability to comply with schedule for follow-up visits

Exclusion criteria

• For keratoconus, a history of previous corneal surgery or the insertion of Intacs in the eye to be treated
• Corneal pachymetry ≤ 400 microns
• Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision
• A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
• Pregnancy (including plan to become pregnant) or lactation during the course of the study
• A known sensitivity to study medications
• Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests
• A condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
• Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for cross-linking or study participation or may confound the outcome of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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127 participants in 2 patient groups

CXL Treatment

Experimental group

Description:

Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.

Treatment:

Device: The VEGA UV-A Illumination System

Drug: Riboflavin

Sham Control

Active Comparator group

Description:

Eyes in the control group will be treated with riboflavin only.

Treatment:

Drug: Riboflavin