Evaluation of the Agreement Between Automated Program-Operated Phoropter Subjective Refraction and Optometrist-Performed Subjective Refraction

NCT07891897 | Not Yet Recruiting

• 1 other identifier: 2026KYPJ109
• Study Type: interventional
• Target: 508
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Refractive Errors

Outcome Measures

Primary Outcomes (1)

• Agreement in refractive prescriptions between automated and optometrist-performed subjective refraction

  Agreement between automated subjective refraction and optometrist-performed subjective refraction will be evaluated using measurements from the right eye as the primary analysis eye. The paired differences in spherical power and cylindrical power, measured in diopters (D), and cylinder axis, measured in degrees, will be analyzed using Bland-Altman analysis to estimate the mean difference (bias) and 95% limits of agreement. Intraclass correlation coefficients (ICCs) will also be calculated. The prespecified clinically acceptable limits are ±0.25 D for spherical and cylindrical power and ±5 degrees for cylinder axis.

  Day 1, after completion of both subjective refraction examinations.

Secondary Outcomes (4)

• Examination time for each subjective refraction method

  Day 1, during each subjective refraction examination.

• Repeatability of the automated subjective refraction system

  Day 1, after completion of both automated subjective refraction measurements

• Agreement between the two subjective refraction methods under cycloplegic and non-cycloplegic conditions

  Day 1, after completion of both subjective refraction examinations.

• Participant acceptance, comfort, and satisfaction with the automated refraction procedure

  Day 1, immediately after completion of both subjective refraction examinations.

Study Arms (2)

Automated Refraction First

EXPERIMENTAL

Participants first undergo subjective refraction using the automated program-controlled refraction system, followed by a rest interval of at least 20 minutes and then subjective refraction performed by an optometrist. Pediatric participants undergo cycloplegia before both examinations. The first 50 adult participants undergo an additional automated refraction examination for repeatability assessment.

Diagnostic Test: Automated Program-Controlled Subjective Refraction; Diagnostic Test: Optometrist-Performed Subjective Refraction

Optometrist Refraction First

EXPERIMENTAL

Participants first undergo subjective refraction performed by an optometrist, followed by a rest interval of at least 20 minutes and then subjective refraction using the automated program-controlled refraction system. Pediatric participants undergo cycloplegia before both examinations. The first 50 adult participants undergo an additional automated refraction examination for repeatability assessment.

Diagnostic Test: Automated Program-Controlled Subjective Refraction; Diagnostic Test: Optometrist-Performed Subjective Refraction

Interventions

Automated Program-Controlled Subjective Refraction DIAGNOSTIC_TEST

Subjective refraction is performed using an automated program operating a standard phoropter to determine sphere, cylinder, and axis. The system incorporates an in-house AI algorithm that has not been registered as a medical device. Its results are used for research purposes only and do not guide spectacle prescription or other clinical decisions. The first 50 adult participants undergo a second automated measurement for repeatability assessment.

Automated Refraction First; Optometrist Refraction First

Optometrist-Performed Subjective Refraction DIAGNOSTIC_TEST

Subjective refraction is independently performed by a qualified optometrist according to a standardized operating procedure to determine sphere, cylinder, and axis. The optometrist is unaware of the results generated by the automated refraction system when performing the examination.

Automated Refraction First; Optometrist Refraction First

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.
• Inability to follow and respond to system instructions. ⑤ Only one eye meeting the eligibility criteria.
• Considered unsuitable for participation by the investigator.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

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