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 date has not been verified as actual or estimated.
Primary Completion
July 2014
Actual (reported)
Study Completion
July 2014
Actual (reported)
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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
completed
Estimated enrollment
22 participants
Study completion date
July 2014
Actual (reported)
Listed locations
1 countries · 8 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
October 2011
Date type not reported
This date has not been verified as actual or estimated.
low risk subjects for developing post-operative ectasia
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
You may not qualify if:
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
Contact the study team to confirm eligibility.
TLC Laser Eye Center
Fairfax, Virginia, 22031, United States
Heterocyclic Compounds, 2-Ring
Heterocyclic Compounds, Fused-Ring
Heterocyclic Compounds
Heterocyclic Compounds, 3-Ring
Coenzymes
Enzymes and Coenzymes
Pigments, Biological
Biological Factors
Study Completion
July 2014
Actual (reported)
Last Updated
August 24, 2015
Record last verified: 2015-08
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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