Comparison of Corneal Collagen Cross-Linking Performed With "Epi-ON" Versus "Epi-OFF" Techniques in Eyes With Keratoconus and Other Corneal Ectatic Disorders
Overview
- Phase
- Phase 3
- Intervention
- Ricrolin+
- Conditions
- Keratoconus
- Sponsor
- Center for Sight, Sacramento, CA
- Enrollment
- 550
- Locations
- 1
- Primary Endpoint
- Mean change in corneal curvature
- Status
- Not yet recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a prospective, randomized, single investigative site study to compare the safety and effectiveness of Epi-OFF CXL treatment (performed using Ricrolin+ and VEGA UV-A system) compared to Epi-ON CXL (performed using Ricrolin+ and VEGA UV-A system) in eyes with keratoconus and other corneal ectatic disorders.Subjects will be randomized to receive the CXL treatment with either the Epi-On or Epi-Off technique.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Be at least 12 years of age or older, male or female, of any race.
- •Having a diagnosis of keratoconus or other corneal ectatic disorder.
- •Presence of central or inferior steepening on the topography map.
- •Axial topography consistent with keratoconus or other corneal ectatic disorder.
- •For eyes diagnosed with keratoconus, presence of one or more slit lamp findings associated with keratoconus, such as:
- •Scissoring of the retinoscopic reflex
- •Fleischer ring
- •Vogt striae
- •Corneal thinning e .Corneal scarring
- •BSCVA 20/20 or worse.
Exclusion Criteria
- •One of the randomized CXL techniques (Epi-OFF or Epi-ON) is contraindicated or, in the investigator's clinical judgment, is not able to be performed in the study eye.
- •Study eye keratoconus severity is classified as being normal or atypical normal based on the OPD-Scan III keratoconus classification indices.
- •A history of previous corneal transplant in the study eye.
- •A history of prior CXL in the study eye.
- •Corneal pachymetry \< 375 microns at the thinnest point as measured by ultrasound pachymetry in the study eye before epithelium removal. \[NOTE: Eyes with corneal pachymetry between \<375 microns and 325 microns may be enrolled in the compassionate use group.\]
- •Presence of Intacs or corneal rings or segments in the study eye.
- •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 unrelated to keratoconus.
- •Eyes which are aphakic.
Arms & Interventions
Epi-OFF CXL
The Epi-ON treatment will be performed without removal of the corneal epithelium. Ricrolin+will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-ON treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-ON treatment.
Intervention: Ricrolin+
Epi-OFF CXL
The Epi-ON treatment will be performed without removal of the corneal epithelium. Ricrolin+will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-ON treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-ON treatment.
Intervention: VEGA UV-A system
Epi-ON CXL
The Epi-OFF treatment will be performed with removal of the corneal epithelium before the first dose of riboflavin is administered. Ricrolin+ will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-OFF treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-OFF treatment.
Intervention: Ricrolin+
Epi-ON CXL
The Epi-OFF treatment will be performed with removal of the corneal epithelium before the first dose of riboflavin is administered. Ricrolin+ will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-OFF treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-OFF treatment.
Intervention: VEGA UV-A system
Outcomes
Primary Outcomes
Mean change in corneal curvature
Time Frame: Baseline, 6 Months, and 12 Months
Percentage of eyes that had a greater than 2D increase in Kmax measured by the OPD-Scan III
Secondary Outcomes
- Change in manifest refraction spherical equivalent(Baseline, 6 Months, and 12 Months)
- Change in best-corrected visual acuity (BSCVA)(Baseline, 6 Months, and 12 Months)
- Change in uncorrected-visual acuity (UCVA)(Baseline, 6 Months, and 12 Months)
- Change in thinnest pachymetry(Baseline, 6 Months, and 12 Months)