An interventional study of Automated Program-Controlled Subjective Refraction and Optometrist-Performed 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
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.
427 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.
This study's planned enrollment of 508 is above the median of 81 across 307 interventional studies indexed under Refractive Errors.
Browse Refractive Errors studies →Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.
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Children aged 7-16 years or adults aged 18 years or older, of either sex.
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.
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
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
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.
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.
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.
Time frame: Day 1, after completion of both subjective refraction examinations.
Examination time for each subjective refraction method
The duration of each subjective refraction examination will be recorded in minutes, from the start of the refraction procedure to completion of the final refractive prescription. The paired examination durations for automated subjective refraction and optometrist-performed subjective refraction will be compared within each participant.
Time frame: Day 1, during each subjective refraction examination.
Repeatability of the automated subjective refraction system
Among the first 50 adult participants who undergo two automated subjective refraction measurements, test-retest repeatability will be evaluated for spherical power and cylindrical power, measured in diopters (D), and cylinder axis, measured in degrees. Repeatability will be quantified using the intraclass correlation coefficient (ICC), within-subject standard deviation (Sw), and coefficient of repeatability.
Time frame: Day 1, after completion of both automated subjective refraction measurements
Agreement between the two subjective refraction methods under cycloplegic and non-cycloplegic conditions
Agreement between automated subjective refraction and optometrist-performed subjective refraction will be evaluated separately in participants examined under cycloplegic conditions and those examined under non-cycloplegic conditions. Children will undergo both examinations after cycloplegia, whereas adults will undergo both examinations without cycloplegia. For each subgroup, paired differences in spherical power and cylindrical power, measured in diopters (D), and cylinder axis, measured in degrees, will be assessed using Bland-Altman analysis and intraclass correlation coefficients (ICCs).
Time frame: Day 1, after completion of both subjective refraction examinations.
Participant acceptance, comfort, and satisfaction with the automated refraction procedure
The seven-item 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, immediately after completion of both subjective refraction examinations.
No study locations are listed for this record.
Plan to share: No — No external sharing of individual participant data is currently planned.
No publications or documents are linked to this record.
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 ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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