Consistency of an Automated Subjective Refraction Program Between Personnel With Diverse Professional Backgrounds and Senior Optometrists
1 other identifier
interventional
254
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2026
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2026
CompletedFirst Posted
Study publicly available on registry
October 23, 2026
CompletedStudy Start
First participant enrolled
November 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
Study Completion
Last participant's last visit for all outcomes
February 28, 2027
October 23, 2026
September 1, 2026
2 months
October 11, 2026
October 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Agreement in refractive prescriptions between operators from different professional backgrounds and senior optometrists using the same automated refraction program
Day 1, after completion of both subjective refraction examinations
Secondary Outcomes (3)
Examination time for comparison operators and senior optometrists using the automated refraction program
Day 1, during each subjective refraction examination.
Participant acceptance, comfort, and satisfaction with the automated refraction procedure
Day 1, after completion of both subjective refraction examinations.
Adverse events and ocular discomfort during the examinations
Day 1, during both subjective refraction examinations.
Study Arms (6)
Nurse First
EXPERIMENTALParticipants 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.
Senior Optometrist First: Nurse Group
EXPERIMENTALParticipants 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.
Village Doctor First
EXPERIMENTALParticipants 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.
Senior Optometrist First: Village Doctor Group
EXPERIMENTALParticipants 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.
Trained Lay Personnel First
EXPERIMENTALParticipants 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.
Senior Optometrist First: Trained Lay Personnel Group
EXPERIMENTALParticipants 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.
Interventions
A trained nurse operates the automated refraction program to complete the full subjective refraction procedure and obtain spherical power, cylindrical power, and cylinder axis.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2026
First Posted
October 23, 2026
Study Start (Estimated)
November 1, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
February 28, 2027
Last Updated
October 23, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share
No external sharing of individual participant data is currently planned.