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

Completed

• Conditions: Fruste Keratoconus; Risk of Ectasia
• Interventions: Device: Corneal Cross-Linking; Drug: Riboflavin

• Registration Number: NCT01726283
• Lead Sponsor: Cxlusa

Brief Summary

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.

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 Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-11-09
• Study First Submitted QC: 2012-11-09
• Study First Posted: 2012-11-14
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-20
• Last Update Posted: 2015-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
low risk subjects for developing post-operative ectasia	Corneal Cross-Linking	Patients undergoing vision correction surgery who are not at a higher risk for developing post-op ectasia
Subjects at Risk for Ectasia	Corneal Cross-Linking	Patients undergoing vision correction surgery who are at a higher risk for developing post-operative ectasia
low risk subjects for developing post-operative ectasia	Riboflavin	Patients undergoing vision correction surgery who are not at a higher risk for developing post-op ectasia
Subjects at Risk for Ectasia	Riboflavin	Patients undergoing vision correction surgery who are at a higher risk for developing post-operative ectasia

Primary Outcome Measures

Name	Time	Method
Postoperative Best-Corrected Visual Acuity	Month 9

Secondary Outcome Measures

Name	Time	Method
Residual Refractive error at the 1, 3 and 6 month visits	Months 1, 3, and 6

Trial Locations

Locations (7)

Talamo Laser Eye Center; 🇺🇸 Waltham, Massachusetts, United States

Schwartz Laser Eye Center; 🇺🇸 Scottsdale, Arizona, United States

Cleveland Eye Clinic; 🇺🇸 Breckville, Ohio, United States

Clear View Eye & Laser Medical Center; 🇺🇸 San Diego, California, United States

The Center for Excellence in Eye Care; 🇺🇸 Miami, Florida, United States

Minnesota Eye Consultants; 🇺🇸 Minneapolis, Minnesota, United States

TLC Laser Eye Center; 🇺🇸 Fairfax, Virginia, United States