Clinical trial NCT01726283: Combined CXL//UV and PRK or LASIK in Forme Fruste Keratoconus or Eyes With Potential Risk of Ectasia
Official title: Combined Collagen Crosslinking/Ultraviolet-A and Photorefractive Keratectomy or LASIK in Forme Fruste Keratoconus or Eyes With Potentially Elevated Risk of Ectasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fruste Keratoconus
Risk of Ectasia
Keywords: fruste keratoconus
ectasia
Lead sponsor: Cxlusa
Sponsor class: INDUSTRY
First posted: 2012-11-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinic

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.

Eligibility 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

Primary outcomes:
measure: Postoperative Best-Corrected Visual Acuity
timeFrame: Month 9
Secondary outcomes:
measure: Residual Refractive error at the 1, 3 and 6 month visits
timeFrame: Months 1, 3, and 6
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Schwartz Laser Eye Center
state: Arizona
city: San Diego
country: United States
facility: Clear View Eye & Laser Medical Center
state: California
city: Miami
country: United States
facility: The Center for Excellence in Eye Care
state: Florida
city: Rockville
country: United States
facility: TLC Laser Eye Center
state: Maryland
city: Waltham
country: United States
facility: Talamo Laser Eye Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Minnesota Eye Consultants
state: Minnesota
city: Breckville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: Fairfax
country: United States
facility: TLC Laser Eye Center
state: Virginia
Study officials:
affiliation: Center For Excellence In Eye Care
name: William Trattler, MD
role: STUDY_DIRECTOR
affiliation: CXL-USA
name: Roy Rubinfeld
role: STUDY_DIRECTOR
References: