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Evaluation of the agreement between automated Program-Operated phoropter subjective refraction and Optometrist-Performed subjective refraction

NCT ID NCT07891897

Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University 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 This study
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 Results may not be published yet.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
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
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Expanded access (paused)
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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

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Status unknown
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First seen Oct 23, 2026 · Last updated Oct 23, 2026

Summary

This study aims to evaluate the performance of an automated subjective refraction system that operates a digital phoropter. By comparing its results with those obtained through conventional subjective refraction performed by an optometrist, the study will assess the agreement in refractive prescriptions and examine examination efficiency, repeatability, and participant experience, thereby providing evidence for the further application of automated subjective refraction technology.

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

About 508 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Feb 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.

Ages

7 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 7-16 years or adults aged 18 years or older, of either sex. * Astigmatism magnitude of 1.50 D or less. ③ Children must be able to undergo cycloplegia. ④ Voluntary participation in the study with written informed consent. Exclusion Criteria: * Concomitant ocular diseases causing opacity of the ocular media, such as cataract, glaucoma, or fundus disease. * History of ocular trauma or intraocular surgery. * Manifest strabismus or significant binocular vision dysfunction. * Inability to follow and respond to system instructions. ⑤ Only one eye meeting the eligibility criteria. * Considered unsuitable for participation by the investigator.

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Conditions

The condition(s) this trial relates to.

refractive error

As listed by the trial registrant

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

Refractive errors

How to take part

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  1. The official record

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