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RecruitingNCT05027295Updated Jan 4, 2023

Accelerated Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Pulse or Continuous UV-A Light

A Phase 3 interventional study of riboflavin ophthalmic solution and riboflavin ophthalmic solution in Keratoconus and Corneal Ectasia, sponsored by Cornea and Laser Eye Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-04.

Sponsored by Cornea and Laser Eye Institute · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Jul 2021; still recruiting 5 years 3 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Corneal collagen crosslinking has been demonstrated as an effective method of reducing progression of both keratoconus and post-refractive corneal ectasia, as well as decreasing the steepness of the cornea in these pathologies.

Performing an accelerated CXL procedure with pulsed UVA light may increase the oxygenation of the cornea, which may improve the crosslinking efficacy.

Read the detailed description

This is a prospective, single-site study to analyze the use of continuous vs pulsed UVA light after removal of the epithelium for the collagen crosslinking procedure for keratoconus and post-refractive corneal ectasia. In the standard crosslinking treatment, the cornea is treated with a continuous UVA light treatment with a power of 3mW/cm2 for 30 minutes. CXL treatment can potentially be performed in a shorter period of time by increasing the power of the UVA light and decreasing the exposure time, while maintaining the same total energy delivered to the cornea. This study will compare the efficacy and safety of accelerated crosslinking using either a continuous or pulsed UVA treatment. One group will be randomized to be treated with 12mW/cm2 of continuous UVA light treatment for 7.5 minutes and the other group will be treated with 12mW/cm2 of pulsed UVA light treatment for 15 minutes.

The primary efficacy parameter that will be evaluated over time is maximum keratometry (Kmax) in the randomized eyes for each treatment group. The secondary efficacy parameter is to determine if the two treatment groups are equivalent in their mean Kmax change at 6 months after treatment compared with baseline.

02

Conditions studied

  • Keratoconus
  • Corneal Ectasia

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Keywords

  • keratoconus
  • corneal ectasia
  • collagen crosslinking
  • riboflavin
  • crosslinking
  • corneal crosslinking
03

In context

Keratoconus

313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.

This study's planned enrollment of 170 is above the median of 40 across 205 interventional studies indexed under Keratoconus.

Browse Keratoconus studies →

Lead sponsor

Cornea and Laser Eye Institute is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years of age or older having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery
  • Presence of central or inferior corneal steepening on the Pentacam map
  • Axial topography consistent with keratoconus or post-surgical corneal ectasia
  • Contact lens wearers only: removal of contact lenses for the required period of 1 week prior to the screening refraction
  • Signed written
  • Willingness and ability to comply with schedule for follow-up visits

Exclusion criteria

Exclusion Criteria:

  • Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme
  • Corneal pachymetry measuring 300 microns or less at the thinnest point measured by Pentacam in the eye(s) to be treated

  • Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:

    1. History of corneal disease (e.g. herpes simplex, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal melt, corneal dystrophy, etc.
    2. scarring in the CXL treatment zone
  • A history of chemical injury or delayed healing in the eye(s) to be treated
  • Pregnancy (including plan to become pregnant) or lactation during the course of the study
  • A known sensitivity to study medications
  • Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests
  • Patients with current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
170 participants (estimated)

Study arms

  • Active comparator
    Continuous UVA

    Riboflavin administration one drop every two minutes with administration of 12mW/cm2 of continuous UVA light for 7.5 minute exposure time

    Drug: riboflavin ophthalmic solution

  • Active comparator
    Pulsed UVA

    Riboflavin administration one drop every two minutes with administration of 12mW/cm2 of pulsed UVA light for 15 minute exposure time

    Drug: riboflavin ophthalmic solution

Interventions

06

What researchers measure

Primary outcomes

  1. Maximum keratometry

    The change in maximum keratometry (Kmax) from baseline will be evaluated at 6 months

    Time frame: 6 months

Secondary outcomes

  1. Mean keratometry

    Determine whether the two treatment groups are equivalent in their mean keratometry (meanK) change at 6 months post treatment compared with baseline.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2021 (actual). Primary completion is estimated for Jul 2025, 48 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2021
First posted
Aug 30, 2021
StartActual
Jul 30, 2021
Primary completionEst.
Jul 2025
CompletionEst.
Jul 2025
Last update
Jan 4, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05027295
Lead sponsor
Cornea and Laser Eye Institute
Responsible party
Sponsor
First posted
Aug 30, 2021
Start date
Jul 30, 2021
Primary completion
Jul 2025 (estimated)
Completion
Jul 2025 (estimated)
Last update
Jan 4, 2023

Study contacts

BethAnn Furlong-Hibbert
Contact
bfurlong-hibbert@vision-institute.com
(201) 692-9434
Stacey Lazar
Contact
slazar@vision-institute.com
(201) 692-9434
Peter S Hersh, MD
study director · Cornea and Laser Eye Institute, Hersh Vision Group

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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