The Effects of Corneal Collagen Cross-linking | NCT01708538

Studies
The Effects of Corneal Collagen Cross-linking

NCT01708538

Sponsor

Rush Eye Associates

Status

Unknown status

Last Update Posted

Oct 26, 2022Actual

Enrollment

30Estimated

Phase

Phase 3

Conditions

Corneal Ectasia Disorders Including Keratoconus

Interventions

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

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Oct 2024Estimated

Completion Date

Oct 2024Estimated

First Submitted Date

Oct 15, 2012

First Submission Date that Met QC Criteria

Oct 16, 2012

First Posted Date

Oct 17, 2012Estimated

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

Oct 24, 2022

Last Update Posted Date

Oct 26, 2022Actual

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

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

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Epithelium on	Active Comparator	Epi not removed during CXL treatment	Drug: CXL
Epithelium off	Active Comparator	Epi removed before CXL treatment	Drug: CXL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CXL	Drug	corneal crosslinking	Epithelium off Epithelium on

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual acuity	Best corrected Snellen acuity	1 year
Keratometry measurements	Average curvature of the cornea	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Unwilling or unable to participate in trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sloan W Rush, MD	Contact	806-353-0125

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rush Eye Associates	Recruiting	Amarillo	Texas	79106	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27388250	Derived	Rush SW, Rush RB. Epithelium-off versus transepithelial corneal collagen crosslinking for progressive corneal ectasia: a randomised and controlled trial. Br J Ophthalmol. 2017 Apr;101(4):503-508. doi: 10.1136/bjophthalmol-2016-308914. Epub 2016 Jul 7.

Type	Date	Date Unknown
Release	Jan 20, 2023
Reset	Feb 14, 2023
Release	Apr 4, 2023
Reset	Apr 25, 2023
Release	Apr 25, 2024
Reset	May 22, 2024

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 20, 2023			Feb 14, 2023
Apr 4, 2023

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases