Safety and Effectiveness Study of the VEGA UV-A System for Cross-linking in Eyes With Keratoconus and Ectasia

Topcon

Status and phase: Terminated; Phase 3

Conditions: Keratoconus and Ectasia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01398852

CXL-003

Details and patient eligibility

About

The purpose of this research study is to evaluate the long tern safety and effectiveness of cross-linking in eyes with keratoconus and ectasia.

Enrollment: 500 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 12 years of age or older
• Diagnosis of Keratoconus or Ectasia
• Central or Inferior steepening on the Pentacam map
• Topography consistent with Keratoconus or Ectasia
• BSCVA 20/20 or worse
• Removal of contact lenses for 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
• Corneal pachymentry equal to or greater and 400
• Previous ocular condition in the eyes to be treated that may predispose the eye for future complications
• A history of chemical injury or delayed healing
• Pregnancy
• A known sensitivity to the study medications
• Nystagmus or any other condition that would prevent a steady gaze during treatment or other diagnostic tests
• Presence or history of any other condition or finding that makes the patient unsuitable as a candidate

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

CXL Treatment

Experimental group

Description:

All eyes to be treated with riboflavin and UV light

Treatment:

Device: VEGA UV-A Illumination System

Drug: Riboflavin