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

Phase 3

Terminated

• Conditions: Keratoconus
• Interventions: Drug: Riboflavin; Device: The VEGA UV-A Illumination System

• Registration Number: NCT01190306
• Lead Sponsor: Topcon Medical Systems, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-25
• Study First Submitted QC: 2010-08-25
• Study First Posted: 2010-08-27
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2012-12-13
• Results First Submitted QC: 2013-01-28
• Results First Posted: 2013-03-04
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-05
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 127

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Control	Riboflavin	Eyes in the control group will be treated with riboflavin only.
CXL Treatment	The VEGA UV-A Illumination System	Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
CXL Treatment	Riboflavin	Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.

Primary Outcome Measures

Name	Time	Method
Change in Corneal Curvature.	6 Months

Trial Locations

Locations (9)

Woolfson Eye Institute; 🇺🇸 Atlanta, Georgia, United States

Barnet Dulaney Perkins Eye Center; 🇺🇸 Phoenix, Arizona, United States

Minnesota Eye Consultants; 🇺🇸 Bloomington, Minnesota, United States

Mt. Sinai Hospital; 🇺🇸 New York, New York, United States

OSU Department of Ophthalmoloty; 🇺🇸 Columbus, Ohio, United States

Pamel Vision & Laser Group; 🇺🇸 New York, New York, United States

Revision Advanced Laser Eye Center; 🇺🇸 Columbus, Ohio, United States

Dell Laser Consultants; 🇺🇸 Austin, Texas, United States

Slade & Baker Vision Center; 🇺🇸 Houston, Texas, United States