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Shorter UV treatment for keratoconus put to the test

NCT ID NCT05019768

Disease control Sponsor: Ciro Caruso Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers compare two ultraviolet light protocols for corneal cross-linking in people with progressive keratoconus. One is the standard Dresden protocol, and the other is an accelerated custom-fast method that uses a mathematical model to set the light intensity and time. Both use riboflavin with vitamin E TPGS. The trial measures changes in corneal shape, vision, and corneal stiffness over two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
corneal cross-linking with riboflavin and vitamin E TPGS
What this could lead to
If the accelerated protocol works as well as the standard one, it could offer a shorter treatment time for people with progressive keratoconus.
What could go wrong
This is a small study of 41 people, so the results may not apply broadly. Cross-linking carries risks such as infection, haze, or failure to stop progression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

41 people

The number who actually took part.

Started

Sep 2017

Finished

Dec 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * documented progressive keratoconus * changes in uncorrected distance visual acuity (UDVA) above 1.00 D * Corrected distance visual acuity (BCVA) above 1.00 D * spherical equivalent greater than 0.50 D Exclusion Criteria: * Corneal pachymetry of less than 400 µm * less than 2000 cells/cm2, * corneal scarring, * nystagmus or any motility disorder that prevented a fixed gaze during the examination * Current contact lens use

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Conditions

The condition(s) this trial relates to.

keratoconus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Keratoconus

Contacts and locations

Locations

  • Pellegrini Hospital

    Naples, Italy

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