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Laser surgery offers new hope for kids with stubborn lazy eye

NCT ID NCT03610997

Disease control Sponsor: Baylor College of Medicine Source: ClinicalTrials.gov ↗

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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
The trial has finished. Results may not be published yet.
Stopped early This study
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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether laser eye surgery (PRK) could improve vision in children aged 2 to 17 with lazy eye (amblyopia) caused by large differences in prescription between eyes or very high nearsightedness, farsightedness, or astigmatism. These children had not improved after at least 6 months of standard treatments like glasses or patching. The surgery aimed to correct the underlying refractive error to help the eyes work better together.

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

200 people

The number who actually took part.

Started

Jan 2001

Finished

Sep 2024

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

2 to 17 years

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:. * Children aged 2 to 17 with significant anisometropia or isoametropia and amblyopia that have failed traditional treatment for at least 6 months. * Anisometropic group: * The anisometropia must be at least 3.00 diopters. * The amblyopic eye best corrected visual acuity must be at least 2 lines worse than the fellow eye in verbal children * Isoametropic group * Myopia must be at least -4.00 diopters in both eyes * Hyperopia must be at least +4.00 diopters in both eyes * Astigmatism must be at least +2.50 diopters in both eyes. Exclusion Criteria: * History of significant corneal abnormality that, in the investigator's opinion, may limit visual rehabilitation. * History of known collagen disorder * History of known corneal ectasia * History of previous herpes simplex keratitis * Corneal thickness of less than 450u

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Conditions

The condition(s) this trial relates to.

amblyopia ametropic amblyopia anisometropia astigmatism degenerative myopia hyperopia

As listed by the trial registrant

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

Amblyopia bilateral Amblyopia isometropic Anisometropia High astigmatism High myopia Hyperopia

Contacts and locations

Locations

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

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