Trials Sponsors Conditions Drugs Pricing

Conditions

Keratoconus and Ectasia

Outcome Measures

Primary Outcomes (1)

Changes in Corneal Curvature
24 MO

Study Arms (1)

CXL Treatment

EXPERIMENTAL

All eyes to be treated with riboflavin and UV light

Drug: RiboflavinDevice: VEGA UV-A Illumination System

Interventions

RiboflavinDrug

Riboflavin is a solution that will be delivered to the treatment area

CXL Treatment

VEGA UV-A Illumination SystemDevice

This is a portable electronic device designed to deliver a dose of UV-A light to the treatment area

CXL Treatment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

years of age or older
Diagnosis of Keratoconus or Ectasia

Sponsors & Collaborators

Topcon Medical Systems, Inc.
Industrylead

Study Sites (13)

Barnet Dulaney Perkins Eye Center

Phoenix, Arizona, United States

Woolfson Eye Institute

Atlanta, Georgia, United States

Massachusetts Eye And Ear Infirmary

Boston, Massachusetts, United States

Minnesota Eye Consultants

Bloomington, Minnesota, United States

Laser and Corneal Surgery Assoc. PC

New York, New York, 10022, United States

Mt Sinai Hospital

New York, New York, United States

Pamel Vision & Laser Group

New York, New York, United States

MeSH Terms

Conditions

KeratoconusDilatation, Pathologic

Interventions

Riboflavin

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FlavinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title: Bob Gibson
Organization: Topcon Medical Systems

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

500 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NA
Masking: NONE
Purpose: OTHER
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 11, 2011

First Posted

July 21, 2011

Study Start

December 2010

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

CXL Treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

CXL Treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations