An observational study in Fruste Keratoconus and Risk of Ectasia, sponsored by Cxlusa. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-24.
Sponsored by Cxlusa · Observational
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.
307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's planned enrollment of 22 is below the median of 130 across 94 observational studies indexed under Keratoconus.
Browse Keratoconus studies →Cxlusa is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Primary Care Clinic
Exclusion Criteria:
Patients undergoing vision correction surgery who are not at a higher risk for developing post-op ectasia
Device: Corneal Cross-Linking · Drug: Riboflavin
Patients undergoing vision correction surgery who are at a higher risk for developing post-operative ectasia
Device: Corneal Cross-Linking · Drug: Riboflavin
Corneal cross-linking procedure conducted during vision correction surgery.
Riboflavin will be instilled prior to corneal cross linking.
Postoperative Best-Corrected Visual Acuity
Time frame: Month 9
Residual Refractive error at the 1, 3 and 6 month visits
Time frame: Months 1, 3, and 6
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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