Study of Safety and Efficacy of Photochemically Induced Collagen Cross-Linking at an Irradiance of 18 mW/cm2 as Constant or Pulsed Treatment in Eyes With Unstable Corneas Due to Keratoconus, Ectasia, or Post-Incisional Refractive Surgery
Overview
- Phase
- Phase 3
- Intervention
- UV Light - Continuous Beam
- Conditions
- Unstable Corneas
- Sponsor
- Crowd Health Research, LTD
- Enrollment
- 500
- Locations
- 16
- Primary Endpoint
- Visual Acuity
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the Safety and Efficacy of Corneal Cross Linking in a Continuous Beam versus Pulsed Treatments across epithelium on and epithelium off surfaces.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Eyes classified as either normal, atypical normal,
- •Corneal pachymetry ≤ 350 microns at the thinnest point measured by Orbscan, Pentacam, or ultrasound in the eye to be treated
- •A history of chemical injury or delayed epithelial healing in the eye to be treated.
- •A known sensitivity to study medications
- •Patients with significant nystagmus or any other condition that would prevent a steady gaze during the treatment
- •Inability to cooperate with diagnostic tests.
- •Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
- •Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.
- •Patients who are unable to remain comfortable and stable, and tolerate a lid speculum for the appointed period of time for the procedure.
Arms & Interventions
Epi-Off Continuous
Continuous beam of UV light treating cornea without surface epithelium present
Intervention: UV Light - Continuous Beam
Epi-On Continuous
Continuous beam of UV light treating cornea with surface epithelium present
Intervention: Epithelium-On Riboflavin
Epi-On Continuous
Continuous beam of UV light treating cornea with surface epithelium present
Intervention: UV Light - Continuous Beam
Epi-Off Continuous
Continuous beam of UV light treating cornea without surface epithelium present
Intervention: Epithelium-Off Riboflavin
Epi-On Pulsed
Pulsed beam of UV light treating cornea with surface epithelium present
Intervention: Epithelium-On Riboflavin
Epi-On Pulsed
Pulsed beam of UV light treating cornea with surface epithelium present
Intervention: UV Pulsed Beam
Epi-Off Pulsed
Pulsed beam of UV light treating cornea without surface epithelium present
Intervention: Epithelium-Off Riboflavin
Epi-Off Pulsed
Pulsed beam of UV light treating cornea without surface epithelium present
Intervention: UV Pulsed Beam
Outcomes
Primary Outcomes
Visual Acuity
Time Frame: 2 years
Uncorrected visual acuity