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Evaluation of the Agreement Between Automated Program-Operated Phoropter Subjective Refraction and Optometrist-Performed Subjective Refraction
Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
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.
Key Details
Gender
All
Age Range
7 Years - Any
Study Type
INTERVENTIONAL
Enrollment
508
Start Date
2026-11-01
Completion Date
2027-02-28
Last Updated
2026-10-23
Healthy Volunteers
Yes
Conditions
Interventions
Automated Program-Controlled Subjective Refraction
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.
Optometrist-Performed Subjective Refraction
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.