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

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ClinicalTrials.gov Identifier: NCT01726283
Recruitment Status : Completed
First Posted : November 14, 2012
Last Update Posted : August 24, 2015
Sponsor:
Information provided by (Responsible Party):
Cxlusa

November 9, 2012
November 14, 2012
August 24, 2015
October 2011
July 2014   (Final data collection date for primary outcome measure)
Postoperative Best-Corrected Visual Acuity [ Time Frame: Month 9 ]
Same as current
Complete list of historical versions of study NCT01726283 on ClinicalTrials.gov Archive Site
Residual Refractive error at the 1, 3 and 6 month visits [ Time Frame: Months 1, 3, and 6 ]
Same as current
Not Provided
Not Provided
 
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 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.
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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Primary Care Clinic
  • Fruste Keratoconus
  • Risk of 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.
  • 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
    Interventions:
    • Device: Corneal Cross-Linking
    • Drug: Riboflavin
  • Subjects at Risk for Ectasia
    Patients undergoing vision correction surgery who are at a higher risk for developing post-operative ectasia
    Interventions:
    • Device: Corneal Cross-Linking
    • Drug: Riboflavin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
500
July 2014
July 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01726283
CXL-RSR
No
Not Provided
Not Provided
Cxlusa
Cxlusa
Not Provided
Study Director: William Trattler, MD Center For Excellence In Eye Care
Study Director: Roy Rubinfeld CXL-USA
Cxlusa
August 2015