Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia

NCT ID: NCT00567671

Last Updated: 2010-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-06-30

Brief Summary

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Prospective, randomized, single site study to determine the safety and effectiveness of performing corneal collagen cross-linking (CCCL)using riboflavin and UVA light in eyes with corneal ectasia or progressive keratoconus.

Detailed Description

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Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. Corneal collagen cross-linking is performed as a single treatment. Subjects are followed for at least 12 months to evaluate the long term effects of corneal collagen cross-linking.

Subjects may be referred from other physicians but must return to Emory Vision for completion of all study visits.

Conditions

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Progressive Keratoconus Corneal Ectasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Corneal collagen cross-linking

Group Type EXPERIMENTAL

Corneal collagen

Intervention Type PROCEDURE

Corneal collagen cross-linking with riboflavin/UVA light

Control

Sham Treatment

Group Type SHAM_COMPARATOR

Sham comparator

Intervention Type PROCEDURE

Sham treatment

Interventions

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Corneal collagen

Corneal collagen cross-linking with riboflavin/UVA light

Intervention Type PROCEDURE

Sham comparator

Sham treatment

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of keratoconus with documented progression over the previous 12 months.
* Diagnosis of corneal ectasia
* Must be able to complete all study visits

Exclusion Criteria

* Prior corneal surgery in the keratoconus group
* Corneal scarring
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Woolfson Eye Intitute

Principal Investigators

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R. Doyle Stulting, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory Vision; Emory University

Locations

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Woolfson Eye Institute

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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Hallahan KM, Rocha K, Roy AS, Randleman JB, Stulting RD, Dupps WJ Jr. Effects of corneal cross-linking on ocular response analyzer waveform-derived variables in keratoconus and postrefractive surgery ectasia. Eye Contact Lens. 2014 Nov;40(6):339-44. doi: 10.1097/ICL.0000000000000090.

Reference Type DERIVED
PMID: 25365551 (View on PubMed)

Related Links

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http://www.emoryvision.com

Click here to contact the investigator site for this study.

Other Identifiers

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UVX-001

Identifier Type: -

Identifier Source: org_study_id

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