The Effect of the Free-toroidal Design Lenses on the Subjective Visual Quality in the Myopic Population

Completed

• Conditions: Myopia; Refractive Errors

• Registration Number: NCT05684302
• Lead Sponsor: Tianjin Eye Hospital

Brief Summary

A prospective, self-control, double-blind design was conducted in Tianjin. Two hundred participants were assigned to wear two kinds of spectacle glasses. To examine the effect of free-toroidal design and aspherical lens on the subjective visual quality among the myopic population.

Detailed Description

A prospective, self-control, double-blind design was conducted in Tianjin. Two hundred participants were assigned to wear two kinds of spectacle glasses. To examine the effect of free-toroidal design and aspherical lens on the subjective visual quality among the myopic population. The subjective visual quality of clarity and comfort were determined using a questionnaire when first wearing the glasses and after 1week.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-12-24
• Study Completion: 2021-12-24
• Status Verified: 2022-12
• Study First Submitted: 2022-12-24
• Study First Submitted QC: 2023-01-11
• Last Update Submitted: 2023-01-11
• Study First Posted: 2023-01-13
• Last Update Posted: 2023-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• health volunteers
• their spherical refraction from -0.50 to -8.00 Diopter, with the cylinder diopter less than -3.00 Diopter
• best corrected visual acuity (BCVA)≥ 20/20 in both eyes
• stable refraction (no change greater than 0.5 Diopter within two years)

Exclusion Criteria

• if they had Aphakic or intraocular lens eyes, had a history of trauma, active eye disease or ocular surgery, serious systemic diseases, or had a wearing history of corneal contact lenses.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The clarity score	baseline visit time	The clarity score by a questionnaire,scores on the questionnaire range from 1 to 6, with higher scores being better
The comfort score	baseline visit time	The comfort score by a questionnaire,scores on the questionnaire range from 1 to 6, with higher scores being better

Secondary Outcome Measures

Name	Time	Method
Accuracy of foveal and peripheral visual acuity	baseline visit time	Accuracy of foveal and peripheral visual acuity was assessed by the eye movement tracking device

Trial Locations

Locations (1)

Tianjin Eye Hospital; 🇨🇳 Tianjin, China