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NCT07891897
Evaluation of the Agreement Between Automated Program-Operated Phoropter Subjective Refraction and Optometrist-Performed Subjective Refraction
Conditions: Refractive Errors
Sex: All
Ages: 7 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 508
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.
Eligibility Criteria
Inclusion Criteria:
* 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.
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.
* Considered unsuitable for participation by the investigator.
Source: ClinicalTrials.gov (NCT07891897). StuddyBuddy aggregates publicly available trial information.