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

NCT01097447 | Terminated

• 1 other identifier: CXL (2)
• Study Type: observational
• Target: 2,619
• Locations: 1 country
• Sites: 5

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

Conditions

Keratoconus; Ectasia; Degeneration

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within

  1 year

Secondary Outcomes (1)

• increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin

  1 year

Study Arms (3)

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

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cxlusa: lead

Study Sites (5)

Clear View Eye & Laser Medical Center

San Diego, California, 92121, United States

Location

Corneal Consultants of Colorado, P.C

Littleton, Colorado, United States

Location

Chicago Cornea Consultants, LTD

Hoffman Estates, Illinois, United States

Location

Minnesota Eye Consultants, P.A.

Bloomington, Minnesota, 55431, United States

Location

Cornea Associates of Texas

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Keratoconus; Dilatation, Pathologic

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: April 1, 2010
• Study Start: December 1, 2009
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)