Collagen Crosslinking With Ultraviolet-A in Asymmetric Co... | NCT01024322

Studies
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

NCT01024322

Sponsor

Cxlusa

Status

Terminated

Last Update Posted

Oct 11, 2018Actual

Enrollment

1,189Actual

Phase

Not provided

Conditions

Keratoconus
Ectasia
Degeneration

Interventions

Ciprofloxicine or Vigamox or other.
Nonsteroidal (Acular, Voltaren Xibrom, etc)
Steroid (FML, Pred Forte, Flarex, etc.)

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Terminated to initiate FDA IND-cleared study protocol

Expanded Access Info

Start Date

Oct 1, 2009Actual

Primary Completion Date

Feb 3, 2017Actual

Completion Date

Feb 3, 2017Actual

First Submitted Date

Oct 28, 2009

First Submission Date that Met QC Criteria

Dec 1, 2009

First Posted Date

Dec 2, 2009Estimated

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 10, 2018

Last Update Posted Date

Oct 11, 2018Actual

Description Module

Brief Summary

To evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,189Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ciprofloxicine or Vigamox or other.			Drug: Ciprofloxicine or Vigamox or other.
Nonsteroidal (Acular, Voltaren Xibrom, etc)			Drug: Nonsteroidal (Acular, Voltaren Xibrom, etc)
Steroid (FML, Pred Forte, Flarex, etc.)			Drug: Steroid (FML, Pred Forte, Flarex, etc.)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ciprofloxicine or Vigamox or other.	Drug	Ciprofloxicine or Vigamox or other to be used qid till epithelialized.	Ciprofloxicine or Vigamox or other.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within		1 year

Secondary Outcomes

Measure	Description	Time Frame
increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

8 years of age or older
Diagnosis of keratoconus, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration.
Diagnosis of FFKC
History of Radial Keratotomy with fluctuating vision.
Terrien's Marginal Degeneration
Ability to provide written informed consent
Likely to complete all study visits
Minimum corneal thickness of at least 300 250 microns measured by ultrasound or Pentacam for all indications other than Terriens. For Terriens, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment.

Exclusion Criteria:

Severe corneal scarring that markedly affects vision
Contraindications to any study medications or their components
Pregnancy or breast feeding
Active Herpes Corneal Disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Primary care clinic.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
William Trattler, MD	The Center for Excellence in Eye Care	Principal Investigator
Roy Rubinfeld, MD	Re: Vision	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Center for Excellence in Eye Care		Miami	Florida	33176	United States
TLC Laser Eye Center

Condition Browse Module

MeSH Terms

ID	Term
D007640	Keratoconus
D004108	Dilatation, Pathologic

Ancestor Terms

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077266	Moxifloxacin
D020911	Ketorolac Tromethamine
D013256	Steroids
D005469	Fluorometholone
C009935	prednisolone acetate

Ancestor Terms

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines

Browse Leaves

Not provided

Browse Branches

Not provided