To Evaluate the Consistency and Repeatability of Portable Automatic Optometry 2-WINS for Cycloplegic Optometry in Adolescents and Children

Completed

• Conditions: Optometry

• Registration Number: NCT06346626
• Lead Sponsor: He Eye Hospital

Brief Summary

Myopia, also known as short-sightedness or near-sightedness, is a prevalent condition that typically emerges during childhood and early adulthood. It occurs when the eye elongates excessively, causing images of distant objects to focus in front of the retina, leading to blurred distance vision. The number of people with myopia is increasing every year, reaching half of the world's population by 2050. The global potential productivity loss due to uncorrected refractive errors was $244 billion in 2015. Due to the strong association between high myopia and pathological changes in the choroid, retina, and sclera, leading to irreversible vision loss, and the fact that correcting the refractive error does not halt the progression of pathology, the prevention of myopia, especially high myopia, has emerged as a crucial international public health concern. In ocular examinations of children under noncycloplegic conditions, the influence of accommodation cannot be disregarded.

Cycloplegic refraction is widely regarded as the gold standard in epidemiological assessment of refractive errors in pediatric populations. Moreover, due to children's decreased cooperation and unreliable responses, subjective refraction tests are less valued, and objective tests under cycloplegia are preferred. The portable vision screener 2WIN-S is a binocular tool that detects various ocular abnormalities and measures the refraction of both eyes. Along with measuring phorias/tropias in prismatic diopters and objective refraction in the range of -15D to +15D, 2WIN-S also captures additional features.

This study employed the cycloplegic condition to measurements using 2WIN-S, ARK-1 and subjective testing, we wanted to test the reliability and accuracy of 2WIN-S.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-26
• Primary Completion: 2024-04-01
• Study First Submitted QC: 2024-04-03
• Study First Posted: 2024-04-04
• Study Completion: 2024-06-01
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

• Younger than 18 years old;
• The best corrected visual acuity is better than 0.1 (logmar);
• Patients undergoing eye mydriasis examination in the outpatient department of our hospital;
• Volunteer to participate in the study.

Exclusion Criteria

• The subject who can not cooperate to complete the inspection;
• Have other eye diseases that cannot be dilated (such as angle-closure glaucoma, shallow front, etc.;
• Have other conditions that affect eye refraction, such as strabismus and previous eye surgery;
• Investigate other conditions that the doctor thinks should not be involved.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The optometric result (2WIN-S)	One day	The optometric result of 2WIN-S

Secondary Outcome Measures

Name	Time	Method
The optometric result(subjective refraction)	One day	The optometric result between 2WIN-S and subjective refraction
The optometric result(ARK-1)	One day	The optometric result between 2WIN-S and ARK-1

Trial Locations

Locations (1)

He Eye Specialist Hospital; 🇨🇳 Shenyang, Liaoning, China