NCT04213885CompletedPhase 2
Safety and Effectiveness of the PXL Platinum 330 System for Corneal Collagen Cross-Linking With Corneal Thinning Conditions
Eye Specialists of Indiana2 sites in 1 country12 target enrollmentStarted: May 4, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Mean keratometry in diopters
Study Overview
Brief Summary
To determine whether the Peschke PXL-330 is safe and effective in the treatment of corneal thinning conditions.
Detailed Description
Patients with progressive keratoconus, pellucid marginal degeneration, infectious keratitis, or at risk for post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery. Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, intraocular pressure and visual function questionnaire.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Randomized at outset
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Criterion 1,2,3 are required for all participants. Participants must also meet one or more of criteria 4-
- •Criteria 13 is only relevant for contact lens wearers.
- •12 years of age or older
- •Signed written informed consent
- •Willingness and ability to comply with schedule for follow-up visits
- •Presence of central or inferior steepening
- •Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
- •Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as
- •Fleisher 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 greater than or equal to 47.2
- •I-S keratometry difference < 1.5 D on the Pentacam map or topography map
- •Posterior corneal elevation > 16 microns
- •Thinnest corneal point <485 microns
- •Predicted Post LASIK/PRK stromal ablation depth <350 microns or expected keratometry >47.2, or patients undergoing PRK/SMILE in keratoconus suspect eyes
- •Bacterial or fungal 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 require period of time prior to the screening refraction:
- •Contact Lens Type Discontinuations Time: Soft, 1 week; Soft Extended Wear, 2 weeks; Soft Toric, 3 weeks; Rigid Gas Permeable, 2 weeks per decade of wear -
Exclusion Criteria
- •Eyes classified as normal or atypical normal on the severity grading scheme
- •Corneal pachymetry at the screening exam that is <300 microns at the 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, acanthamoeba, etc.)
- •Clinically significant corneal scarring 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 the study medications
- •Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment of diagnostic tests.
- •Patients with a current condition that, in the physician's opinion, wold interfere with or prolong epithelial healing.
Outcomes
Primary Outcomes
Mean keratometry in diopters
Time Frame: 1 year
Average keratometry across the anterior topography of the cornea computed by a validated Scheimpflug topographer
Secondary Outcomes
- Best corrected visual acuity(1 year)
Investigators
Study Sites (2)
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