Can a smart device predict how a Child's eye grows?

NCT ID NCT07803094

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Registered, but not yet taking participants.
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Paused for now. It may or may not start again.
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The trial has finished. Results may not be published yet.
Stopped early
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Cancelled before anyone took part.

Expanded access (not trials)

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Approved
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First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

Researchers are testing a new device called SmartEyes that measures refractive errors, which are vision problems like nearsightedness. The study involves 200 children and teens aged 6 to 17 who need eye exams. The trial compares SmartEyes with standard equipment and subjective refraction to see if it gives consistent and repeatable results. It also checks whether SmartEyes' fine-scale data can better predict short-term eye growth than traditional methods, which could help manage myopia progression.

What this could mean

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

Active substance
SmartEyes smart refraction measuring device
What this could lead to
If successful, SmartEyes could offer a faster, more accurate way to measure vision problems in children and help predict how the eye grows, potentially improving myopia management.
What could go wrong
This is a validation study, not a treatment trial. The device may not prove more accurate than existing methods, and results in children at one hospital may not apply broadly.

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.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

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.

Who is studied

Pediatric and adolescent outpatients presenting for routine optometric examinations and refractive status evaluation at the clinical site.

Ages

6 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: 1. Aged 6-17 years old, no gender limit; 2. Visiting the outpatient optometry room of Wuhan Children's Hospital, clinically required refraction examination; 3. Ability to cooperate in completing SmartEyes, Topcon KR-800, Topcon KR-1W examinations; 4. Able to complete reliable subjective refraction; 5. Subjects in the mydriasis subgroup should be those who need mydriasis/cycloplegia refraction for clinical diagnosis and treatment; 6. Those who participate in the second phase cohort must be able to complete the axial length measurement and be willing to return to complete the 3-month (and 6-month) follow-up as planned; 7. Guardians are fully informed and sign written informed consent; 8. Subject children accept research notifications based on their age and understanding ability, and express agreement or no objection to participating in the research. Exclusion Criteria: 1. Those unable to maintain stable fixation, unable to cooperate with desktop equipment for examination, or unable to perform reliable subjective refraction; 2. Obvious strabismus, nystagmus, severe amblyopia, or other conditions affecting the reliability of objective/subjective refraction; 3. Keratoconus, obviously irregular astigmatism, corneal scarring, corneal edema, or other corneal diseases that significantly affect refractive measurement; 4. Moderate to severe cataracts, obvious lens opacity, vitreous opacity, fundus diseases, and other conditions that may affect the refraction endpoint; 5. History of previous corneal refractive surgery or intraocular surgery; 6. Still wearing orthokeratology lenses, RGP, or other contact lenses on the day and determined by the investigator to affect measurement results; 7. Participants in the second phase cohort who are unable to complete follow-up, plan to undergo eye surgery in the short term, or have investigators who judge axial measurement results to be clearly unreliable will not be included in the cohort follow-up analysis; 8. Other circumstances where the investigator determines the participant is unsuitable for this study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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