Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Co… (NCT04094090) | Clinical Trial Compass
RecruitingPhase 2
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia
United States500 participantsStarted 2019-10-19
Plain-language summary
To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.
Who can participate
Age range10 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓.10 years of age or older 2. Presence of central or inferior steepening 3. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration 4. Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as:
✓. Fleischer ring
✓. Vogt's striae
✓. Decentered corneal apex
✓. Munson's sign
✓. Apical Corneal scarring consistent with Bowman's breaks
✓. Scissoring of the retinoscopic reflex
✓. Crab-claw appearance on topography 5. Steepest keratometry (Kmax) value ≥ 47.20 D 6. I-S keratometry difference \> 1.5 D on the Pentacam map or topography map 7. Posterior corneal elevation \>16 microns 8. Thinnest corneal point \>300 microns 9. Contact Lens Wearers Only:
Exclusion criteria
✕. 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 nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.