ClinicalTrials.gg
Not yet recruitingNCT07891884Updated Oct 23, 2026

Consistency of an Automated Subjective Refraction Program Between Personnel With Diverse Professional Backgrounds and Senior Optometrists

An interventional study of Nurse-Operated Automated Subjective Refraction and Village Doctor-Operated Automated Subjective Refraction in Refractive Errors, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Not yet recruiting. Open to participants aged 7 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Diagnostic

Updated Oct 23, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
254
Allocation
Randomized
Ages
7 Years and older
Sex
All
01

Study summary

This study aims to evaluate the performance of automated subjective refraction performed by operators with different professional backgrounds. By comparing their results with those obtained by a senior optometrist using the same automated refraction program, the study will assess agreement in refractive prescriptions and examine examination efficiency, participant experience, and safety, thereby providing evidence for the further application of automated subjective refraction technology.

02

Conditions studied

  • Refractive Errors

Browse trials for

03

In context

Refractive Errors

427 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's planned enrollment of 254 is above the median of 81 across 307 interventional studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 7 years or older, of either sex. ② Astigmatism magnitude of 1.50 D or less. ③ Voluntary participation in the study with written informed consent.

Exclusion criteria

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. ④ Inability to follow and respond to system instructions. ⑤ Only one eye meeting the eligibility criteria.

        • Considered unsuitable for participation by the investigator.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
254 participants (estimated)

Study arms

  • Experimental
    Nurse First

    Participants first undergo automated subjective refraction performed by a trained nurse, followed by a rest interval of at least 20 minutes and then automated subjective refraction performed by a senior optometrist using the same program. The two operators are blinded to each other's refraction results.

    Diagnostic Test: Nurse-Operated Automated Subjective Refraction · Diagnostic Test: Senior Optometrist-Operated Automated Subjective Refraction

  • Experimental
    Senior Optometrist First: Nurse Group

    Participants first undergo automated subjective refraction performed by a senior optometrist, followed by a rest interval of at least 20 minutes and then automated subjective refraction performed by a trained nurse using the same program. The two operators are blinded to each other's refraction results.

    Diagnostic Test: Nurse-Operated Automated Subjective Refraction · Diagnostic Test: Senior Optometrist-Operated Automated Subjective Refraction

  • Experimental
    Village Doctor First

    Participants first undergo automated subjective refraction performed by a trained village doctor, followed by a rest interval of at least 20 minutes and then automated subjective refraction performed by a senior optometrist using the same program. The two operators are blinded to each other's refraction results.

    Diagnostic Test: Village Doctor-Operated Automated Subjective Refraction · Diagnostic Test: Senior Optometrist-Operated Automated Subjective Refraction

  • Experimental
    Senior Optometrist First: Village Doctor Group

    Participants first undergo automated subjective refraction performed by a senior optometrist, followed by a rest interval of at least 20 minutes and then automated subjective refraction performed by a trained village doctor using the same program. The two operators are blinded to each other's refraction results.

    Diagnostic Test: Village Doctor-Operated Automated Subjective Refraction · Diagnostic Test: Senior Optometrist-Operated Automated Subjective Refraction

  • Experimental
    Trained Lay Personnel First

    Participants first undergo automated subjective refraction performed by trained lay personnel, followed by a rest interval of at least 20 minutes and then automated subjective refraction performed by a senior optometrist using the same program. The two operators are blinded to each other's refraction results.

    Diagnostic Test: Lay Personnel-Operated Automated Subjective Refraction · Diagnostic Test: Senior Optometrist-Operated Automated Subjective Refraction

  • Experimental
    Senior Optometrist First: Trained Lay Personnel Group

    Participants first undergo automated subjective refraction performed by a senior optometrist, followed by a rest interval of at least 20 minutes and then automated subjective refraction performed by trained lay personnel using the same program. The two operators are blinded to each other's refraction results.

    Diagnostic Test: Lay Personnel-Operated Automated Subjective Refraction · Diagnostic Test: Senior Optometrist-Operated Automated Subjective Refraction

Interventions

  • Diagnostic testNurse-Operated Automated Subjective Refraction

    A trained nurse operates the automated refraction program to complete the full subjective refraction procedure and obtain spherical power, cylindrical power, and cylinder axis.

  • Diagnostic testVillage Doctor-Operated Automated Subjective Refraction

    A trained village doctor operates the automated refraction program to complete the full subjective refraction procedure and obtain spherical power, cylindrical power, and cylinder axis.

  • Diagnostic testLay Personnel-Operated Automated Subjective Refraction

    Trained lay personnel who have passed competency assessment operate the automated refraction program to complete the full subjective refraction procedure and obtain spherical power, cylindrical power, and cylinder axis.

  • Diagnostic testSenior Optometrist-Operated Automated Subjective Refraction

    A senior optometrist operates the same automated refraction program according to a standardized procedure to obtain spherical power, cylindrical power, and cylinder axis. These measurements serve as the reference results for comparison.

06

What researchers measure

Primary outcomes

  1. Agreement in refractive prescriptions between operators from different professional backgrounds and senior optometrists using the same automated refraction program

    Time frame: Day 1, after completion of both subjective refraction examinations

Secondary outcomes

  1. Examination time for comparison operators and senior optometrists using the automated refraction program

    Time frame: Day 1, during each subjective refraction examination.

  2. Participant acceptance, comfort, and satisfaction with the automated refraction procedure

    The questionnaire assesses three aspects: understanding and operation, comfort and visual fatigue, and acceptance and willingness to use. Each item is rated on a 5-point Likert scale from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating a more favorable evaluation.

    Time frame: Day 1, after completion of both subjective refraction examinations.

  3. Adverse events and ocular discomfort during the examinations

    Time frame: Day 1, during both subjective refraction examinations.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — No external sharing of individual participant data is currently planned.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07891884
Responsible party
Sponsor
First posted
Oct 23, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Oct 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion