The Effects of Corneal Collagen Cross-linking

This study is currently recruiting participants.

Verified October 2012 by Rush Eye Associates

Sponsor:

Information provided by (Responsible Party):

Rush Eye Associates

ClinicalTrials.gov Identifier:

NCT01708538

First received: October 15, 2012

Last updated: October 16, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 15, 2012

Last Updated Date

October 16, 2012

Start Date ^ICMJE

October 2012

Estimated Primary Completion Date

October 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Visual acuity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Best corrected Snellen acuity
Keratometry measurements [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Average curvature of the cornea

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01708538 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The Effects of Corneal Collagen Cross-linking

Official Title ^ICMJE

Phase III Study of Corneal Collagen Cross-linking Using Two Different Techniques.

Brief Summary

The corneal collagen cross-linking treatment has been used with increasing success to treat corneal dystrophies such as "keratoconus." Recent advances have allowed different techniques for performing this cross-linking treatment. This study investigates the effects of corneal cross-linking using different surgical techniques.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Corneal Ectasia Disorders Including Keratoconus

Intervention ^ICMJE

Drug: CXL

corneal crosslinking

Study Arm (s)

Active Comparator: Epithelium on
Epi not removed during CXL treatment

Intervention: Drug: CXL
Active Comparator: Epithelium off
Epi removed before CXL treatment

Intervention: Drug: CXL

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

October 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age 10-70, willing to participate, diagnosis of corneal ectasia disorder

Exclusion Criteria:

Unwilling or unable to participate in trial

Gender

Both

Ages

10 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Sloan W Rush, MD

806-353-0125

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01708538

Other Study ID Numbers ^ICMJE

Rush CXL

Has Data Monitoring Committee

Yes

Responsible Party

Rush Eye Associates

Study Sponsor ^ICMJE

Rush Eye Associates

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Rush Eye Associates

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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