Corneal Collagen Cross-Linking (CXL) Performed With "Epi-ON" Versus "Epi-OFF" in Eyes With Keratoconus and Other Corneal Ectatic Disorders

Status unconfirmed · Phase 3

Conditions studied: Keratoconus, Ectasia

In brief

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.

Key facts

Study ID

NCT03858036

Run by

Center for Sight, Sacramento, CA

People needed

550

Starts

2019-03-08

Expected to finish

2024-12-31

Last updated by the study team

2019-02-28

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Center for Sight — Sacramento, California, United States

Full record on ClinicalTrials.gov

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