Corneal Collagen Cross-Linking for the Treatment of Progr... | NCT00567671

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

NCT00567671

Sponsor

Emory University

Status

Completed

Last Update Posted

Sep 2, 2010Estimated

Enrollment

160Estimated

Phase

Phase 2Phase 3

Conditions

Progressive Keratoconus
Corneal Ectasia

Interventions

Corneal collagen
Sham comparator

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Dec 3, 2007

First Submission Date that Met QC Criteria

Dec 4, 2007

First Posted Date

Dec 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2010

Last Update Posted Date

Sep 2, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	Corneal collagen cross-linking	Procedure: Corneal collagen
Control	Sham Comparator	Sham Treatment	Procedure: Sham comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Corneal collagen	Procedure	Corneal collagen cross-linking with riboflavin/UVA light	Treatment

Measure	Description	Time Frame
Change in keratometry		3 Months

Measure	Description	Time Frame
Best spectacle-corrected visual acuity		3 Months

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
R. Doyle Stulting, MD, PhD	Emory Vision; Emory University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Woolfson Eye Institute		Atlanta	Georgia	30328	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25365551	Derived	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.

Type	Date	Date Unknown
Release	Oct 1, 2013
Reset	Nov 30, 2013

ID	Term
D007640	Keratoconus
D004108	Dilatation, Pathologic
D003316	Corneal Diseases

ID	Term
D005128	Eye Diseases
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D010778	Photochemotherapy
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy