New light therapy aims to halt cornea disease and save sight
NCT ID NCT04094090
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a device that uses riboflavin (vitamin B2) drops and UV light to stiffen the cornea, the clear front part of the eye. It is for people with keratoconus or similar conditions that cause the cornea to bulge and blur vision. The goal is to see if the treatment safely improves vision and stops the disease from getting worse. About 500 participants aged 10 and older will be enrolled.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- riboflavin solution and UV-A light (corneal cross-linking)
- What this could lead to
- If successful, this could provide a safe, effective way to strengthen the cornea and slow or stop vision loss from keratoconus and similar conditions.
- What could go wrong
- This is a mid-stage trial, so results are not yet proven. The procedure may not work for everyone, and risks include infection, scarring, or temporary vision changes.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2019
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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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
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10 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: Subjects who have one or both eyes that meet criteria 1 and 1 or more of the following criteria will be considered candidates for this study: 1.10 years of age or older 2. Presence of central or inferior steepening 3. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration 4. Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as: 1. Fleischer ring 2. Vogt's striae 3. Decentered corneal apex 4. Munson's sign 5. Apical Corneal scarring consistent with Bowman's breaks 6. Scissoring of the retinoscopic reflex 7. Crab-claw appearance on topography 5. Steepest keratometry (Kmax) value ≥ 47.20 D 6. I-S keratometry difference \> 1.5 D on the Pentacam map or topography map 7. Posterior corneal elevation \>16 microns 8. Thinnest corneal point \>300 microns 9. Contact Lens Wearers Only: a. Removal of contact lenses for the required period of time prior to the screening refraction: Contact Lens Type Minimum Discontinuation Time Soft or Scleral 3 days Rigid gas permeable 2 weeks Exclusion Criteria: All subjects meeting any of the following criteria will be excluded from this study: 1. Eyes classified as either normal or atypical normal on the severity grading scheme. 2. Corneal pachymetry at the screening exam that is \<300 microns at the thinnest point in the eye(s) to be treated. 3. 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 or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthomeoeba, etc.) 2. Clinically significant corneal scarring in the CXL treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross-linking procedure. 4. Pregnancy (including plan to become pregnant) or lactation during the course of the study 5. A known sensitivity to study medications 6. Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests. 7. Patients with a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Goodman Eye Center
RECRUITINGSan Francisco, California, 94115, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Shorter eye treatment put to the test against standard crosslinking
- Shorter UV treatment for keratoconus put to the test
- Insulin eye drops put to the test for faster corneal healing
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- Can a Light-Based scan reveal the health of your eyes?