Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- * healthy subjects with no other medical or ocular conditions
- * 18 years of age or older
- * Presence of central or inferior steepening (on Pentacam topograph)
- * Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration (See keratoconus grading section 7.0 for details)
- * Presence of one or more findings associated with keratoconus or pellucid marginal degeneration on slit lamp exam such as:
- * Fleischer ring
- * Vogt's striae
- * Decentered corneal apex
- * Munson's sign
- * Rizzutti's sign
- * Apical Corneal scarring consistent with Bowman's breaks
- * Scissoring of the retinoscopic reflex
- * Crab-claw appearance on topography
- * Steepest keratometry (Kmax) value ≥ 47.20 D on simK or Pentacam
- * I-S keratometry difference \> 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or topography map
- * Posterior corneal elevation \>16 microns (µm on Pentacam tomography)
- * Thinnest corneal point \<485 microns (ultrasound pachymetry or Pentacam tomography)
- * Predicted Post LASIK/PRK stromal ablation depth \<350 microns or expected keratometry \>47.2 D, or patients undergoing PRK/SMILE in keratoconus suspect eyes
- * Bacterial or fungal corneal keratitis persistent and not responding despite \> 2 weeks of standard antimicrobial therapy or with rapid progression of corneal thinning, with loss of \>25% corneal thickness
- * Contact Lens Wearers Only:
- * Removal of contact lenses for the required period of time prior to the screening refraction:
- * Signed written informed consent
- * Willingness and ability to comply with schedule for follow-up visits
- * active infections, collagen vascular disease, allergic to product
- * Eyes classified as either normal or atypical normal on the severity grading scheme.
- * Corneal pachymetry at the screening exam that is \<300 microns at the thinnest point in the eye(s) to be treated.
- * Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
- * History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthomeoeba, etc.)
- * Clinically significant corneal scarring in the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross-linking procedure.
- * Pregnancy (including plan to become pregnant) or lactation during the course of the study
- * A known sensitivity to study medications
- * Patients with cognitive or ambulatory conditions that would prevent eye drop compliance with medications
- * Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
- * Patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing.
Ages Eligible for Study
18 Years to
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
Yes