Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas (2)

Sponsor

Cxlusa (Industry)

Overall Status

Terminated

CT.gov ID

NCT01097447

Collaborator

(none)

2,619

Enrollment

Locations

88.9

Actual Duration (Months)

523.8

Patients Per Site

5.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Keratoconus Ectasia Degeneration

Study Design

Study Type:

Observational

Actual Enrollment :

2619 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Actual Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Apr 30, 2017

Actual Study Completion Date :

Apr 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Ciprofloxicine or Vigamox or other up to qid till epithelialized.
Topical Nonsteroidal (Acular, Acuvail, Voltaren Xibrom up to qid for up to 5-10 days postop
Topical steroid (FML, Pred Forte, Flarex qid for up to 8 weeks

Outcome Measures

Primary Outcome Measures

Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within [1 year]

Secondary Outcome Measures

increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
Ability to provide written informed consent
Likely to complete all study visits
Minimum corneal thickness of at least 300 measured by ultrasound or Pentacam

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clear View Eye & Laser Medical Center	San Diego	California	United States	92121
2	Corneal Consultants of Colorado, P.C	Littleton	Colorado	United States
3	Chicago Cornea Consultants, LTD	Hoffman Estates	Illinois	United States
4	Minnesota Eye Consultants, P.A.	Bloomington	Minnesota	United States	55431
5	Cornea Associates of Texas	Dallas	Texas	United States	75231

Sponsors and Collaborators

Cxlusa

Investigators

Principal Investigator: Parag Majmudar, MD, Chicago Cornea Consultants, LTD
Principal Investigator: Lance Forstot, MD, Corneal Consultants of Colorado, P.C
Principal Investigator: Bradley Bowman, M.D, Cornea Associates of Texas
Principal Investigator: Sandy Feldman, M.D, Clear View Eye & Laser Medical Center
Principal Investigator: Sherman Reeves, MD, Minnesota Eye Consultants, P.A.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cxlusa

ClinicalTrials.gov Identifier:

NCT01097447

Other Study ID Numbers:

CXL (2)

First Posted:

Apr 1, 2010

Last Update Posted:

Oct 11, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Cxlusa

Diagnosis of keratoconus, post-LASIK ectasia, FFKC, or pellucid marginal degeneration

Additional relevant MeSH terms:

Keratoconus

Dilatation, Pathologic

Study Results

No Results Posted as of Oct 11, 2018