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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01726283
First Posted: November 14, 2012
Last Update Posted: August 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cxlusa
  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:


Further study details as provided by Cxlusa:

Primary Outcome Measures:
  • Postoperative Best-Corrected Visual Acuity [ Time Frame: Month 9 ]

Secondary Outcome Measures:
  • Residual Refractive error at the 1, 3 and 6 month visits [ Time Frame: Months 1, 3, and 6 ]

Estimated Enrollment: 22
Study Start Date: October 2011
Study Completion Date: July 2014
Primary Completion Date: July 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726283


Locations
United States, Arizona
Schwartz Laser Eye Center
Scottsdale, Arizona, United States, 85260
United States, California
Clear View Eye & Laser Medical Center
San Diego, California, United States
United States, Florida
The Center for Excellence in Eye Care
Miami, Florida, United States
United States, Maryland
TLC Laser Eye Center
Rockville, Maryland, United States, 20852
United States, Massachusetts
Talamo Laser Eye Center
Waltham, Massachusetts, United States
United States, Minnesota
Minnesota Eye Consultants
Minneapolis, Minnesota, United States
United States, Ohio
Cleveland Eye Clinic
Breckville, Ohio, United States
United States, Virginia
TLC Laser Eye Center
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Cxlusa
Investigators
Study Director: William Trattler, MD Center For Excellence In Eye Care
Study Director: Roy Rubinfeld CXL-USA
  More Information

Responsible Party: Cxlusa
ClinicalTrials.gov Identifier: NCT01726283     History of Changes
Other Study ID Numbers: CXL-RSR
First Submitted: November 9, 2012
First Posted: November 14, 2012
Last Update Posted: August 24, 2015
Last Verified: August 2015

Keywords provided by Cxlusa:
fruste keratoconus
ectasia

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