Corneal Ectasia, Keratoconus, Pellucid Marginal Corneal Degeneration
Conditions
Brief 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.
Detailed description
Patients with progressive keratoconus, pellucid marginal degeneration, 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 pachymetry.
Interventions
COMBINATION_PRODUCTPXL-330 Platinum device for crosslinking with Peschke riboflavin solution
Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea
Sponsors
Colorado Eye Consultants/Cornea Consultants of Colorado
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of keratoconus, forme fruste keratoconus, post-LASIK ectasia, pellucid marginal degeneration, forme fruste pellucid marginal degeneration, history of radial keratotomy with fluctuating vision, Terrien's marginal degeneration. 2. Must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form. 3. Must be willing and able to return for scheduled treatment and follow-up examinations for the duration of the study. 4. Must be at least 8 years of age. 5. Non-consenting/impaired individuals with a LAR's signature
Exclusion criteria
1. Corneal thickness \< 300 microns measured by ultrasound or Pentacam. 2. Contraindications or sensitivities to any study medications or their components. 3. Pregnancy or breastfeeding. 4. Any history of Herpes simplex corneal disease in an eye to be treated. 5. Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment. 6. Inability to cooperate with diagnostic tests. 7. Current enrollment in another ophthalmic clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corrected distance visual acuity | 6 months | Change in corrected distance visual acuity (CDVA) at the last required study visit (6 months post-op), compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected visual acuity | 6 months | Change in UCVA at 6 months, compared to baseline. |
| Keratometry | 12 months | Change in Kmax, compared to baseline. |
Countries
United States
Contacts
Primary ContactShivam Patel, BS
Backup ContactWendy Bigger
Outcome results
None listed