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

Topcon

Status and phase: Terminated; Phase 3

Conditions: Ectasia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01398839

CXL-002

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 ectasia.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 Years of age or older
• Diagnosis of Ectasia
• Presence of central or inferior steepening
• Topography consistent with ectasia
• BSCVA 20/20 or worse
• If contact lens wearer; removal of contact lenses for required period of time
• Signed informed consent
• Willingness and ability to comply with schedule for follow-up visits

Exclusion criteria

• Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision
• History of chemical injury or delayed epithelial healing
• A known sensitivity to study medications
• Nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests
• A condition that would interfere with or prolong epithelial healing
• Presence or history of any other condition or finding that makes the patient unsuitable for treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

Sham Control

Sham Comparator group

Treatment:

Drug: Riboflavin

CXL Treatment

Experimental group

Treatment:

Drug: Riboflavin

Device: VEGA UV-A Illumination System