Can a smart device predict how a Child's eye grows?
NCT ID NCT07803094
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
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2027
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.
Who is studied
Pediatric and adolescent outpatients presenting for routine optometric examinations and refractive status evaluation at the clinical site.
- Ages
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6 to 17 years
- 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: 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
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 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.
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