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

Sponsor:	Innovative Medical
Information provided by (Responsible Party):	Innovative Medical
ClinicalTrials.gov Identifier:	NCT01189864

Purpose

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	Intervention
Keratoconus Ectasia Degeneration	Drug: Ciprofloxicine or Vigamox or other. Drug: Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc) Drug: Steroid (FML, Pred Forte, Flarex, etc.)

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Resource links provided by NLM:

Further study details as provided by Innovative Medical:

Primary Outcome Measures:

Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	June 2010
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Ciprofloxicine or Vigamox or other.	Drug: Ciprofloxicine or Vigamox or other. Ciprofloxicine 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.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Primary care clinic.

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01189864

Contacts

Contact: Jenna Piel	951-653-5566	j.piel@imedsonline.com
Contact: Annie Christensen	951-653-5566	a.christensen@imedsonline.com

Locations

United States, Arizona
Schwartz Laser Eye Center	Recruiting
Scottsdale, Arizona, United States, 85260
Principal Investigator: Jay Schwartz, MD
United States, California
Harvard Eye Associates	Recruiting
Laguna Hills, California, United States
Principal Investigator: John Hovanesian, MD
Clear View Eye & Laser Medical Center	Recruiting
San Diego, California, United States
Principal Investigator: Sandy Feldman, MD
	Recruiting
San Francisco, California, United States
Principal Investigator: Daniel Goodman, MD
Davidorf Eye Group	Recruiting
West Hills, California, United States
Principal Investigator: Jonathan Davidorf, MD
United States, Colorado
Corneal Consultants of Colorado, P.C	Recruiting
Littleton, Colorado, United States
Principal Investigator: Lance Forstot
United States, Florida
The Center for Excellence in Eye Care	Recruiting
Miami, Florida, United States
Principal Investigator: Carlos Buznego, MD
United States, Illinois
Chicago Cornea Consultants, LTD	Recruiting
Hoffman Estates, Illinois, United States, 60169
Principal Investigator: Parag Majmudar, MD
United States, Maryland
Washington Eye Physicians and Surgeons	Recruiting
Chevy Chase, Maryland, United States
Principal Investigator: Marwa Adi, MD
United States, Massachusetts
Talamo Laser Eye Center	Recruiting
Waltham, Massachusetts, United States
Principal Investigator: Jonathan Talamo, MD
United States, Missouri
Ophthalomology Associates	Recruiting
St. Louis, Missouri, United States
Principal Investigator: Gregg Berdy, MD
United States, New York
South Shore Eye Care LLP	Recruiting
Wantagh, New York, United States, 11793
Principal Investigator: Jodi Luchs, MD
United States, Ohio
Cleveland Eye Clinic	Recruiting
Breckville, Ohio, United States, 44141
Principal Investigator: Shamik Bafna, MD
United States, Washington
Northwest Eye Surgeons	Recruiting
Seattle, Washington, United States
Principal Investigator: Audrey Rostov, MD
Empire Eye Physicians	Recruiting
Spokane Valley, Washington, United States
Principal Investigator: Mark Kontos, MD

Sponsors and Collaborators

Innovative Medical

Investigators

Principal Investigator:	Carlos Buznego, MD	The Center for Excellence in Eye Care
Principal Investigator:	Marwa Adi, MD	Washington Eye Physicians and Surgeons
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

More Information

No publications provided

Responsible Party:	Innovative Medical
ClinicalTrials.gov Identifier:	NCT01189864 History of Changes
Other Study ID Numbers:	CXL (12 & older)
Study First Received:	July 20, 2010
Last Updated:	April 4, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Dilatation, Pathologic
Keratoconus
Pathological Conditions, Anatomical
Corneal Diseases
Eye Diseases
Diclofenac
Bromfenac
Ketorolac Tromethamine
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone phosphate
Moxifloxacin

Norgestimate, ethinyl estradiol drug combination
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2012