Status and phase
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About
The objectives of this study are to evaluate the safety and efficacy, with regards to regression of refractive outcome, as measured by manifest refraction spherical equivalent (MRSE), of two treatment regimens for hyperopic and hyperopic astigmatic subjects: LASIK followed by cross-linking performed with the KXL System and Photrexa ZD™ (Riboflavin Ophthalmic Solution), as compared to LASIK alone.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Removal of contact lenses for the required period of time prior to the screening refraction:
Soft - 3 Days
Soft Toric - 2 Weeks
Rigid gas permeable - 2 Weeks
Exclusion criteria
Ocular condition that may predispose the subject to future complications, for example:
History or evidence of active or inactive corneal disease (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal dystrophy, etc.);
Evidence of retinal vascular disease;
Keratoconus or keratoconus suspect;
Glaucoma or glaucoma suspect by exam findings and/or family history;
Primary purpose
Allocation
Interventional model
Masking
2 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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