Corneal Cross-linking for Progressive Keratoconus

This study is looking at the safety and effectiveness of different levels of NXL Energy treatments for people with progressive keratoconus, a condition where your cornea (the clear front part of your eye) thins and bulges. The NXL Energy treatments involve special riboflavin drops and a system that delivers energy. Some participants will receive a sham treatment, which means they get sham drops and no energy exposure. Researchers want to see if these treatments can improve your eye's shape, measured by topography, after 12 months. You might be able to join if you are between 18 and 55 years old, have keratoconus, and can follow study instructions. The study plans to enroll 150 people, but its current status is unclear.

Study design
This is a multi-center study that compares different doses of NXL Energy treatments to a sham treatment. It plans to include 150 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your eye's shape will be measured at 12 months after treatment.

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NCT05314738

Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus

UNKNOWN
PHASE1Ages 18–55InterventionalTreatment
Glaukos Corporation
~150 participants
Updated 2024-07-08 on ClinicalTrials.gov
What's tested:NXL Energy 1NXL Energy 2NXL Energy 3Sham Treatment

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Topography
Measured over 12 Months
Progressive Keratoconus
3 sites across 3 states
Alabama1
New Jersey1
Ohio1

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Provide written informed consent
Ability to hold gaze sufficiently stable for study testing
Willingness and ability to follow all instructions and comply with schedule for follow-up visits
Have a diagnosis of keratoconus

Exclusion

Known allergy or sensitivity to the test articles or components
Any disease causing abnormal topography other than keratoconus
Prior or current ocular condition (other than keratoconus) in the study eye that may predispose the eye for future complications
  • Topography12 Months

    Change in Kmax topography value from baseline