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

Purpose

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.

Condition	Intervention	Phase
Progressive Keratoconus Corneal Ectasia	Procedure: Corneal collagen Procedure: Sham comparator	Phase II Phase III

ChemIDplus related topics:

Riboflavin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study

Official Title:	Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia or Progressive Keratoconus

Further study details as provided by Emory University:

Primary Outcome Measures:

Change in keratometry [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Best spectacle-corrected visual acuity [ Time Frame: 3 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	160
Study Start Date:	December 2007
Estimated Study Completion Date:	March 2009

Arms	Assigned Interventions
Treatment: Experimental Corneal collagen cross-linking	Procedure: Corneal collagen Corneal collagen cross-linking with riboflavin/UVA light
Control: Sham Comparator Sham Treatment	Procedure: Sham comparator Sham treatment

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567671

Contacts


Contact: R. Doyle Stulting, MD, PhD	404-778-6166

Locations


United States, Georgia
	Emory Vision/Emory Clinic	Recruiting
	Atlanta, Georgia, United States, 30342

Sponsors and Collaborators

Emory University

Investigators


Principal Investigator:	R. Doyle Stulting, MD, PhD	Emory Vision; Emory University

More Information

Click here to contact the investigator site for this study. This link exits the ClinicalTrials.gov site

Responsible Party:	Emory University ( R. Doyle Stulting, MD, PhD., Professor of Ophthalmology, Principle Investigator )
Study ID Numbers:	UVX-001
First Received:	December 3, 2007
Last Updated:	December 4, 2007
ClinicalTrials.gov Identifier:	NCT00567671
Health Authority:	United States: Food and Drug Administration

Keywords provided by Emory University:

keratoconus

ectasia

cross-linking

riboflavin

UVA light

cornea

Study placed in the following topic categories:

Pathological Conditions, Anatomical

Corneal Diseases

Riboflavin

Dilatation, Pathologic

Eye Diseases

Keratoconus

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Emory University
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00567671