Cross-linking of Corneal Collagen (CXL) With Ultraviolet-A in Asymmetric Corneas

Sponsor

Cxlusa (Industry)

Overall Status

Terminated

CT.gov ID

NCT01189864

Collaborator

(none)

3,493

Enrollment

Locations

84.1

Actual Duration (Months)

218.3

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is 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. The data generated by this study will not be submitted to the FDA to support commercialization of these riboflavin drops.

Condition or Disease	Intervention/Treatment	Phase
Keratoconus Ectasia Degeneration	Drug: Ciprofloxicin or Vigamox or other. Drug: Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc) Drug: Steroid (FML, Pred Forte, Flarex, etc.)

Study Design

Study Type:

Observational

Actual Enrollment :

3493 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Actual Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Feb 3, 2017

Actual Study Completion Date :

Feb 3, 2017

Arms and Interventions

Arm	Intervention/Treatment
Ciprofloxicin or Vigamox or other.	Drug: Ciprofloxicin or Vigamox or other. Ciprofloxicin or Vigamox or other to be used qid till epithelialized.
Nonsteroidal (Acular, Voltaren Xibrom, etc)	Drug: Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc) Nonsteroidal (Acular, Voltaren Xibrom, etc) qid up to 5-10 days post-op
Steroid (FML, Pred Forte, Flarex, etc.)	Drug: Steroid (FML, Pred Forte, Flarex, etc.) Steroid (FML, Pred Forte, Flarex, etc.) to be used qid to qd for 1-8 weeks.

Arm

Intervention/Treatment

Ciprofloxicin or Vigamox or other.

Drug: Ciprofloxicin or Vigamox or other.

Ciprofloxicin or Vigamox or other to be used qid till epithelialized.

Nonsteroidal (Acular, Voltaren Xibrom, etc)

Drug: Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc)

Nonsteroidal (Acular, Voltaren Xibrom, etc) qid up to 5-10 days post-op

Steroid (FML, Pred Forte, Flarex, etc.)

Drug: Steroid (FML, Pred Forte, Flarex, etc.)

Steroid (FML, Pred Forte, Flarex, etc.) to be used qid to qd for 1-8 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:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

12 years of age or older
Diagnosis of keratoconus, FFKC, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration (FFPMD).
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
At least 6 months since last corneal surgery (Intacs/PRK/LASIK/Epi-LASIK/LASEK)

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	Schwartz Laser Eye Center	Scottsdale	Arizona	United States	85260
2	Harvard Eye Associates	Laguna Hills	California	United States
3	Clear View Eye & Laser Medical Center	San Diego	California	United States
4		San Francisco	California	United States
5	Davidorf Eye Group	West Hills	California	United States
6	Corneal Consultants of Colorado, P.C	Littleton	Colorado	United States
7	The Center for Excellence in Eye Care	Miami	Florida	United States	33176
8	Chicago Cornea Consultants, LTD	Hoffman Estates	Illinois	United States	60169
9	TLC Laser Eye Center	Rockville	Maryland	United States	20852
10	Talamo Laser Eye Center	Waltham	Massachusetts	United States
11	Ophthalomology Associates	Saint Louis	Missouri	United States
12	South Shore Eye Care LLP	Wantagh	New York	United States	11793
13	Cleveland Eye Clinic	Brecksville	Ohio	United States	44141
14	TLC Laser Eye Center	Fairfax	Virginia	United States	22031
15	Northwest Eye Surgeons	Seattle	Washington	United States
16	Empire Eye Physicians	Spokane Valley	Washington	United States

Sponsors and Collaborators

Cxlusa

Investigators

Principal Investigator: William Trattler, MD, The Center for Excellence in Eye Care
Principal Investigator: Jodi Luchs, MD, South Shore Eye Care LLP
Principal Investigator: Shamik Bafna, MD, Cleveland Eye Clinic
Principal Investigator: Parag Majmudar, MD, Chicago Cornea Consultants, LTD
Principal Investigator: Jay Schwartz, MD, Schwartz Laser Eye Center
Principal Investigator: Jonathan Davidorf, MD, Davidorf Eye Group
Principal Investigator: Daniel Goodman, MD, Goodman Eye Center
Principal Investigator: Jonathan Talamo, MD, Talamo Laser Eye Center
Principal Investigator: Sandy Feldman, MD, Clear View Eye & Laser Medical Center
Principal Investigator: Gregg Berdy, MD, Ophthalomology Associates
Principal Investigator: Lance Forstot, Corneal Consultants of Colorado, P.C
Principal Investigator: Mark Kontos, MD, Empire Eye Physicians
Principal Investigator: Audrey Rostov, MD, Northwest Eye Surgeons
Principal Investigator: John Hovanesian, MD, Harvard Eye Associates