Safety and Effectiveness of Corneal Crosslinking (CXL): Keratoconus and Post-Refractive Ectasia
Overview
- Phase
- Phase 3
- Intervention
- Epi-Off
- Conditions
- Keratoconus
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Change in Kmax
- Last Updated
- 7 years ago
Overview
Brief Summary
This prospective, randomized study is being conducted to evaluate the safety and effectiveness of corneal cross-linking (CXL) in patients with keratoconus or post-refractive ectasia (post-LASIK or PRK) utilizing two techniques: the "standard" Epi-Off technique or an Epi-On technique that utilizes iontophoresis (I-CXL) to deliver the riboflavin to the cornea without need for removal of the corneal epithelium. Patients will be randomized to receive CXL treatment with either the Epi-On or Epi-Off technique.
Investigators
Penny Asbell
Professor of Ophthalmology, Director of Cornea and Refractive Services, Director of the Cornea Fellowship Program
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •All subjects meeting any of the following criteria will be excluded from the study:
- •A history of previous corneal surgery in the eye to be treated (including previous CXL treatment)
- •a. Eyes with episodes of hydrops or scarring from hydrops may be included as long as there is no active inflammation
- •Corneal pachymetry \< 400 microns at the thinnest point measured by Pentacam
- •Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications or prevent the possibility of improved vision, for example:
- •History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, or corneal dystrophy, etc.)
- •Clinically significant corneal scarring in the treatment zone
- •A history of chemical injury or delayed epithelial healing in the eye(s) to be treated
- •Pregnancy (including plan to become pregnant) or lactation during the procedure
- •A known sensitivity to study medications
Arms & Interventions
Epi-Off CXL
Using topical anesthesia (proparacaine), the surgeon will create a complete corneal abrasion to facilitate riboflavin diffusion into the cornea. The epithelium will be removed by gently brushing the cornea with a scalpel. A corneal abrasion diameter of \~9mm is recommended, which may be adjusted as needed at the discretion of the investigator to accommodate individual eye geometry. Ultrasound corneal pachymetry should be performed before dis-epithelialization and after dis- epithelialization. Local anesthetics will be administered as needed to maintain patient comfort during the CXL procedure.
Intervention: Epi-Off
Epi-On CXL
The IONTOPHOR CXL iontophoresis applicator and the associated blepharostat will be placed onto the cornea to be treated. The applicator will be secured to the cornea and filled with Ricrolin+ which as been aspirated from the bottle using a syringe with a needle. The generator will be switched on and set to 1 mA for 5 minutes. The generator will then be disconnected and the applicator will be removed from the cornea.
Intervention: Ricrolin+
Outcomes
Primary Outcomes
Change in Kmax
Time Frame: baseline and 2 years
Kmax = maximum simulated keratometry value
Secondary Outcomes
- Change in steepest K(baseline and 2 years)
- Change in sphere(baseline and 2 years)
- Changes in curvature(baseline and 2 years)
- Change in astigmatism(baseline and 2 years)
- Change in keratometry(baseline and 2 years)
- Change in pachymetry(baseline and 2 years)
- Change in cylinder(2 years)
- Change in BCVA(baseline and 2 years)