NCT00647699

Brief Summary

Prospective, randomized multicenter study to determine the safety and effectiveness of performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with progressive keratoconus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2007

Typical duration for phase_3

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

July 7, 2016

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

3.3 years

First QC Date

March 28, 2008

Results QC Date

May 2, 2016

Last Update Submit

April 22, 2021

Conditions

Progressive Keratoconus

Keywords

keratoconuscross-linkingriboflavinUVA lightcornea

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline in Maximum Keratometry (Kmax)

    The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.

    baseline,12 months

Study Arms (2)

Corneal Collagen Cross-linking (CXL) Treatment Group

ACTIVE COMPARATOR

riboflavin ophthalmic solution and UVA irradiation

Drug: riboflavin ophthalmic solutionDevice: UVA Irradiation

Control Group

SHAM COMPARATOR

riboflavin ophthalmic solution without UVA irradiation.

Drug: riboflavin ophthalmic solution

Interventions

riboflavin ophthalmic solutionDRUG

riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)

Control GroupCorneal Collagen Cross-linking (CXL) Treatment Group
UVA IrradiationDEVICE

UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes

Also known as: UV-X Illumination System
Corneal Collagen Cross-linking (CXL) Treatment Group

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of keratoconus
  • Documented progression over previous 24 months
  • Decreased BSCVA
  • Must complete all study visits

You may not qualify if:

  • Prior corneal surgery or Intacs
  • History of delayed wound healing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Shiley Eye Center

La Jolla, California, 92093, United States

Location

Gordon -Weiss Vision Institute

San Diego, California, 91222, United States

Location

Center for Excellence in Eye Care

Miami, Florida, 33176, United States

Location

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

Durrie Vision

Kansas City, Kansas, 66211, United States

Location

Wilmer Eye Institute at Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Minnesota Eye Consultants

Minneapolis, Minnesota, 55404, United States

Location

Cornea & Laser Eye Institute; Hersh Vision Group

Teaneck, New Jersey, 07666, United States

Location

Edward Harkness Eye Institute at Columbia University Medical Center

New York, New York, 10032, United States

Location

Ophthalmic Consultants of Long Island

Rockville Centre, New York, 11570, United States

Location

Related Publications (1)

  • Greenstein SA, Fry KL, Hersh PS. Effect of topographic cone location on outcomes of corneal collagen cross-linking for keratoconus and corneal ectasia. J Refract Surg. 2012 Jun;28(6):397-405. doi: 10.3928/1081597X-20120518-02.

    PMID: 22692521DERIVED

MeSH Terms

Conditions

KeratoconusCorneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
Vineeta Belanger, VP of Clinical Affairs
Organization
Avedro, Inc.
vbelanger@avedro.com
781-768-3459

Study Officials

  • Peter Hersh, MD

    Cornea and Laser Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2008

First Posted

April 1, 2008

Study Start

December 1, 2007

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

April 26, 2021

Results First Posted

July 7, 2016

Record last verified: 2021-04

Locations

US(10)