550 Participants Needed

Corneal Collagen Cross-Linking Techniques for Keratoconus

JL
Overseen ByJasmine Ly, OD
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Center for Sight, Sacramento, CA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for individuals at least 12 years old with keratoconus or other corneal ectatic disorders. Participants must provide consent, have specific topography map changes, and be willing to use birth control if applicable. Those with prior CXL treatment, corneal transplants, certain ocular conditions, allergies to study materials, or inadequate corneal thickness are excluded.

Inclusion Criteria

I have been diagnosed with keratoconus or a similar eye condition.
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 for one month following treatment
Presence of central or inferior steepening on the topography map
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Exclusion Criteria

Study eye keratoconus severity is classified as being normal or atypical normal based on the OPD-Scan III keratoconus classification indices
A known contraindication, sensitivity, or allergy to the test article or its components or to study medications
A specific eye treatment technique cannot be used on me, as per my doctor's advice.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Epi-ON or Epi-OFF corneal collagen cross-linking treatment

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Multiple visits at Baseline, 6 Months, and 12 Months

What Are the Treatments Tested in This Trial?

Interventions

  • Epi-OFF
  • Epi-ON
  • Ricrolin+
  • VEGA UV-A system
Trial Overview The study compares two techniques of Corneal Collagen Cross-Linking (CXL) treatments for strengthening the cornea: Epi-OFF (removal of the outer layer of the cornea) and Epi-ON (outer layer left intact), both using Ricrolin+ and VEGA UV-A system in a randomized design.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Epi-ON CXLActive Control2 Interventions
Group II: Epi-OFF CXLActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Center for Sight, Sacramento, CA

Lead Sponsor

Trials
1
Recruited
550+
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