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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05684302
• Other study ID #: KY202101
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: December 24, 2021

Study information

• Verified date: December 2022
• Source: Tianjin Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 24, 2021
• Est. primary completion date: December 24, 2021
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia
• Refractive Errors

Intervention

Other:
• The free-toroidal design lenses
Participants were asked to wear the new design lenses (the free-toroidal design lenses) for 1 week

Locations

Country	Name	City	State
China	Tianjin Eye Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Eye Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Gannon C, Liang R. Evolving expertise for automated lens optimization. Appl Opt. 2020 Aug 1;59(22):G129-G136. doi: 10.1364/AO.391888. — View Citation

Jalie M. Modern spectacle lens design. Clin Exp Optom. 2020 Jan;103(1):3-10. doi: 10.1111/cxo.12930. Epub 2019 Jun 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The clarity score	The clarity score by a questionnaire,scores on the questionnaire range from 1 to 6, with higher scores being better	baseline visit time
Primary	The comfort score	The comfort score by a questionnaire,scores on the questionnaire range from 1 to 6, with higher scores being better	baseline visit time
Secondary	Accuracy of foveal and peripheral visual acuity	Accuracy of foveal and peripheral visual acuity was assessed by the eye movement tracking device	baseline visit time