Corneal Collagen Cross-linking for Progressive Keratoconus

NCT ID: NCT00647699

Last Updated: 2021-04-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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This was a sham controlled study for the first three months. Patients had one eye designated as the study eye and were randomized to receive one of two study treatments (CXL or sham) in their study eye. The patients were evaluated at 1, 3, 6, and 12 months. At month 3 or later patients had the option of receiving CXL treatment in both the sham and non-study eye.

Conditions

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Progressive Keratoconus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Corneal Collagen Cross-linking (CXL) Treatment Group

riboflavin ophthalmic solution and UVA irradiation

Group Type ACTIVE_COMPARATOR

riboflavin ophthalmic solution

Intervention Type DRUG

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

UVA Irradiation

Intervention Type DEVICE

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

Control Group

riboflavin ophthalmic solution without UVA irradiation.

Group Type SHAM_COMPARATOR

riboflavin ophthalmic solution

Intervention Type DRUG

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

Interventions

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riboflavin ophthalmic solution

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

Intervention Type DRUG

UVA Irradiation

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

Intervention Type DEVICE

Other Intervention Names

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UV-X Illumination System

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Prior corneal surgery or Intacs
* History of delayed wound healing
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glaukos Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Hersh, MD

Role: PRINCIPAL_INVESTIGATOR

Cornea and Laser Institute

Locations

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Shiley Eye Center

La Jolla, California, United States

Site Status

Gordon -Weiss Vision Institute

San Diego, California, United States

Site Status

Center for Excellence in Eye Care

Miami, Florida, United States

Site Status

Price Vision Group

Indianapolis, Indiana, United States

Site Status

Durrie Vision

Kansas City, Kansas, United States

Site Status

Wilmer Eye Institute at Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Minnesota Eye Consultants

Minneapolis, Minnesota, United States

Site Status

Cornea & Laser Eye Institute; Hersh Vision Group

Teaneck, New Jersey, United States

Site Status

Edward Harkness Eye Institute at Columbia University Medical Center

New York, New York, United States

Site Status

Ophthalmic Consultants of Long Island

Rockville Centre, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22692521 (View on PubMed)

Other Identifiers

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UVX-002

Identifier Type: -

Identifier Source: org_study_id

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