Status:
UNKNOWN
Corneal Collagen Cross-Linking (CXL) Performed With "Epi-ON" Versus "Epi-OFF" in Eyes With Keratoconus and Other Corneal Ectatic Disorders
Lead Sponsor:
Center for Sight, Sacramento, CA
Conditions:
Keratoconus
Ectasia
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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.
- Subject is willing to have CXL performed by the Epi-OFF or Epi-ON techniques.
- Provide written informed consent and a signed HIPPA form. Pediatric subjects less than 14 years of age must sign an assent and a parent or legal guardian must sign an informed consent.
- Willingness and ability to follow all instructions and comply with schedule for follow-up visits.
- If female and capable of becoming pregnant, must not be lactating or pregnant and must agree to use a medically acceptable form of birth control for at least one week prior to the treatment visit and to continue o one month following treatment.
Exclusion
- 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.
- Eyes which are pseudophakic and do not have a UV blocking lens implanted.
- A known contraindication, sensitivity, or allergy to the test article or its components or to study medications.
- Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests.
- If female, pregnant, nursing or planning a pregnancy, or having a positive urine pregnancy test prior to the randomization of, or treatment of, either eye during the course of the study.
- A condition that, in the investigator's opinion, would interfere with or prolong epithelial healing, including a history of chemical injury or delayed epithelial healing in the study eye.
- Presence or history or any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for cross-linking or study participation or may confound the outcome of the study.
Key Trial Info
Start Date :
March 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT03858036
Start Date
March 8 2019
End Date
December 31 2024
Last Update
February 28 2019
Active Locations (1)
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1
Center for Sight
Sacramento, California, United States, 95816