Combined CXL//UV and PRK or LASIK in Forme Fruste Keratoconus or Eyes With Potential Risk of Ectasia

Combined Collagen Crosslinking/Ultraviolet-A and Photorefractive Keratectomy or LASIK in Forme Fruste Keratoconus or Eyes With Potentially Elevated Risk of Ectasia

This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia that will be undergoing laser vision correction.

Study Overview

• Status: Completed
• Conditions: Fruste Keratoconus; Risk of Ectasia
• Intervention / Treatment: Device: Corneal Cross-Linking; Drug: Riboflavin

Detailed Description

This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia that will be undergoing laser vision correction. CXL is thought to augment the tectonic strength of the cornea by using UVA light and the photo-mediator riboflavin. The purpose of this non-randomized study is to compare the visual results of patients who are suspicious for having an increased risk of ectasia with laser vision correction compared to a group of patients that does not have these risk factors. All excimer laser ophthalmic procedures currently being performed to correct myopia, hyperopia or astigmatism with FDA approved excimer lasers do so by removing corneal tissue and thereby potentially weakening the cornea biomechanically. This can result in ectasia even in patients without pre-existing risk factors.

• Study Type: Observational
• Enrollment (Anticipated): 22

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Schwartz Laser Eye Center
  • California
    • San Diego, California, United States
      • Clear View Eye & Laser Medical Center
  • Florida
    • Miami, Florida, United States
      • The Center for Excellence in Eye Care
  • Maryland
    • Rockville, Maryland, United States, 20852
      • TLC Laser Eye Center
  • Massachusetts
    • Waltham, Massachusetts, United States
      • Talamo Laser Eye Center
  • Minnesota
    • Minneapolis, Minnesota, United States
      • Minnesota Eye Consultants
  • Ohio
    • Breckville, Ohio, United States
      • Cleveland Eye Clinic
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • TLC Laser Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Primary Care Clinic

Description

Inclusion Criteria:

• 18 years of age or older
• Up to 4 potential risk factors for ectasia
• A. Abnormal Topography: Consistent with forme fruste keratoconus, forme fruste pellucid marginal degeneration, asymmetric astigmatism, or increased posterior float/posterior corneal surface shape.
• B. Corneal thickness of 500 microns or less, as measured by ultrasound, Orbscan, or Pentacam
• C. Age 18 to 25
• D. Planned Residual stromal bed between 250 and 300 microns
• Ability to provide written informed consent
• Likely to complete all study visits
• Best spectacle-corrected visual acuity (BSCVA) of 20/25 in each eye
• Patients with and without previous laser vision correction are eligible for participation.

Exclusion Criteria:

• Frank keratoconus, Pellucid, or Post-LASIK ectasia
• Less than 20/30 BSCVA in either eye
• Corneal scarring that markedly affects vision
• Contraindications to any study medications or their components
• Pregnancy or breast feeding
• Active Herpes Corneal Disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
low risk subjects for developing post-operative ectasia; Patients undergoing vision correction surgery who are not at a higher risk for developing post-op ectasia	Device: Corneal Cross-Linking; Corneal cross-linking procedure conducted during vision correction surgery.; Drug: Riboflavin; Riboflavin will be instilled prior to corneal cross linking.
Subjects at Risk for Ectasia; Patients undergoing vision correction surgery who are at a higher risk for developing post-operative ectasia	Device: Corneal Cross-Linking; Corneal cross-linking procedure conducted during vision correction surgery.; Drug: Riboflavin; Riboflavin will be instilled prior to corneal cross linking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative Best-Corrected Visual Acuity	Month 9

Secondary Outcome Measures

Outcome Measure	Time Frame
Residual Refractive error at the 1, 3 and 6 month visits	Months 1, 3, and 6

Collaborators and Investigators

• Sponsor: Cxlusa
• Investigators: Study Director: William Trattler, MD, Center for Excellence in Eye Care; Study Director: Roy Rubinfeld, CXL-USA

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: November 9, 2012
• First Submitted That Met QC Criteria: November 9, 2012
• First Posted (Estimate): November 14, 2012

Study Record Updates

• Last Update Posted (Estimate): August 24, 2015
• Last Update Submitted That Met QC Criteria: August 20, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: ectasia; fruste keratoconus
• Additional Relevant MeSH Terms: Eye Diseases; Pathological Conditions, Anatomical; Corneal Diseases; Keratoconus; Dilatation, Pathologic; Physiological Effects of Drugs; Photosensitizing Agents; Dermatologic Agents; Micronutrients; Vitamins; Vitamin B Complex; Riboflavin
• Other Study ID Numbers: CXL-RSR