Become an Integral Part of Keratoconus Treatment Research

Join our clinical studies to investigate EpiSmart™ epi-on corneal cross-linking

What is keratoconus?

Keratoconus is an eye disease characterized by vision loss due to progressive thinning and bulging of the cornea, a clear tissue at the front of the eye that helps to focus incoming light.

An investigational treatment called EpiSmart epithelium-on corneal cross-linking may help reduce the risk of progressive vision loss. 

What is EpiSmart corneal cross-linking? 

“Epi” is short for epithelium. The epithelium is the thin, outer layer of the cornea. “Epi-on” means that the epithelium is not removed for treatment. EpiSmart is an epi-on cross-linking treatment, different from epi-off cross-linking. This investigational treatment is a two-step process:

  1. Using a tiny sponge, the cornea is saturated with a study drug solution containing vitamin B-2 (also known as riboflavin) and salt

  2. The cornea is then exposed to ultraviolet A (UVA) light from a proprietary medical device

These two simple steps result in “cross-linking” of the cornea, which stiffens the cornea to potentially prevent further shape changes which can degrade vision. The studies will determine if an epi-on approach is safe and effective.

What is the goal of the EpiSmart clinical studies?

These nationwide studies are researching the investigational EpiSmart treatment (vitamin B-2 study solution eye drops followed by UV light exposure) to find out how well it works compared to a placebo/sham treatment. A placebo/sham treatment looks like the studies’ treatment but does not contain active components.

Find Out if You Qualify

To be eligible you must be:

  • 8 to 45 years of age

  • Diagnosed with keratoconus in one eye or both eyes

  • Have had no previous eye surgeries

This is not a complete list of study requirements. The study doctor will review the full requirements for this study with you.

EpiSmart Keratoconus Treatment Studies Eligibility

What to Expect

  • Physician speaking to clinical trial participant while holding paperwork

    Screening and Enrollment

    The studies are researching an investigational treatment called EpiSmart, which is epithelium-on or epi-on corneal cross-linking, for individuals with keratoconus. The study doctor will review the full requirements of the study treatment with you.

  • One closed and one open door

    Randomization

    If you are eligible to participate, you will be randomly (by chance) assigned by a computer to receive the EpiSmart treatment or placebo/sham.

  • Ophthalmology professional preparing patient for eye procedure

    Treatment

    You will receive the EpiSmart study treatment or placebo/sham at the doctor’s office that is most convenient for you. To keep you comfortable during treatment, numbing drops will be instilled in your eyes.

  • Patient being examined with phoropter

    Monitoring

    You will be required to see the doctor who performed your treatment several times during the year following treatment to monitor your treatment results, health, and safety.

  • Ophthalmologists across the country are participating in these clinical studies. To view a map of active clinical sites and the specific doctors offering these studies, please click here.

  • The EpiSmart study treatment and all study-related assessments will be provided to you at no cost.

  • Participants will be compensated for their time; this detail will be provided to you by a Study Coordinator at the location that is most convenient for you.

  • You will participate in this study for approximately 12.5 months and will visit the study center up to 12 times during this period.

  • There are possible risks involved with any clinical study. Your study doctor will review the risks with you, and you will be closely monitored throughout the study.

  • The study group assignment is masked, meaning participants and caregivers will not know the treatment assignment. The treatment is randomly assigned by a computer. At the conclusion of your treatment follow up period, you will be told which treatment you received, active or placebo/sham.

  • Participants who initially qualify and receive the placebo/sham treatment will be given the opportunity to receive the active EpiSmart treatment at the end of the study at no charge.

  • A clinical study involves research that is intended to add to medical knowledge related to the treatment of diseases or conditions (e.g., keratoconus). Clinical studies enroll volunteers (also called participants) to help researchers answer questions about the study treatment, find out if it works or works better than other treatments, and determine if it has side effects.

  • An investigational (or study) treatment is a treatment that is being tested in clinical studies. A study treatment is one that has not yet been approved by regulatory agencies, such as the United States (US) Food and Drug Administration (FDA). EpiSmart is currently in Phase 3, the final phase of studies before FDA approval.

    Every study treatment must be reviewed and carefully monitored by an ethics committee for testing in clinical study participants.

Frequently Asked Questions

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Locations Offering the EpiSmart Clinical Trial Treatment

Find one of our active clinical sites using the interactive map below.

Contact Us

We look forward to discussing our studies and your options!