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

Phase 3

Terminated

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

• Registration Number: NCT01398852
• Lead Sponsor: Topcon Medical Systems, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-19
• Study First Posted: 2011-07-21
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2012-12-13
• Results First Submitted QC: 2013-01-25
• Results First Posted: 2013-03-04
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 500

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CXL Treatment	Riboflavin	All eyes to be treated with riboflavin and UV light
CXL Treatment	VEGA UV-A Illumination System	All eyes to be treated with riboflavin and UV light

Primary Outcome Measures

Name	Time	Method
Changes in Corneal Curvature	24 MO

Trial Locations

Locations (13)

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

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

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

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

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

The Eye Institute of Utah; 🇺🇸 Salt Lake City, Utah, United States

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

Laser and Corneal Surgery Assoc. PC; 🇺🇸 New York, New York, United States

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

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

Massachusetts Eye And Ear Infirmary; 🇺🇸 Boston, Massachusetts, United States

Cleveland Clinic-Cole Eye Institute; 🇺🇸 Cleveland, Ohio, United States

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