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

This study is currently recruiting participants.
Verified November 2012 by Cxlusa
Sponsor:
Information provided by (Responsible Party):
Cxlusa
ClinicalTrials.gov Identifier:
NCT01726283
First received: November 9, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Fruste Keratoconus
Risk of Ectasia
 Device: Corneal Cross-Linking
Drug: Riboflavin

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Combined Collagen Crosslinking/Ultraviolet-A and Photorefractive Keratectomy or LASIK in Forme Fruste Keratoconus or Eyes With Potentially Elevated Risk of Ectasia

Resource links provided by NLM:

Drug Information available for: Riboflavin
U.S. FDA Resources

Further study details as provided by Cxlusa:

Primary Outcome Measures:
  • Postoperative Best-Corrected Visual Acuity [ Time Frame: Month 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Residual Refractive error at the 1, 3 and 6 month visits [ Time Frame: Months 1, 3, and 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary Care Clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726283

Contacts
Contact: Kristin Williams kristin@lexitaspharma.com

Locations
United States, Arizona
Schwartz Laser Eye Center Recruiting
Scottsdale, Arizona, United States, 85260
Principal Investigator: Jay Schwartz, MD            
United States, California
Clear View Eye & Laser Medical Center Recruiting
San Diego, California, United States
Principal Investigator: Sandy Feldman, MD            
United States, Florida
The Center for Excellence in Eye Care Recruiting
Miami, Florida, United States
Sub-Investigator: William Trattler            
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            
United States, Minnesota
Minnesota Eye Consultants Recruiting
Minneapolis, Minnesota, United States
Principal Investigator: Sherman Reeves, MD            
United States, Ohio
Cleveland Eye Clinic Recruiting
Breckville, Ohio, United States
Principal Investigator: Shamik Bafna, MD            
Sponsors and Collaborators
Cxlusa
Investigators
Study Director: William Trattler, MD Center For Excellence In Eye Care
Study Director: Roy Rubinfeld CXL-USA
  More Information

No publications provided

Responsible Party: Cxlusa
ClinicalTrials.gov Identifier: NCT01726283     History of Changes
Other Study ID Numbers: CXL-RSR
Study First Received: November 9, 2012
Last Updated: November 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cxlusa:
fruste keratoconus
ectasia

Additional relevant MeSH terms:
Dilatation, Pathologic
Keratoconus
Pathological Conditions, Anatomical
Corneal Diseases
Eye Diseases
Riboflavin
Photosensitizing Agents
Radiation-Sensitizing Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013