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

NCT05684302 | Completed

• 1 other identifier: KY202101
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia; Refractive Errors

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Accuracy of foveal and peripheral visual acuity

  baseline visit time

Interventions

The free-toroidal design lenses OTHER

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy myopic people between 18 and 50 years of age

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Eye Hospital: lead

Study Sites (1)

Tianjin Eye Hospital

Tianjin, China

Location

Related Publications (2)

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

  PMID: 31222837 BACKGROUND

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

  PMID: 32749325 BACKGROUND

MeSH Terms

Conditions

Myopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2022
• First Posted: January 13, 2023
• Study Start: January 1, 2021
• Primary Completion: December 24, 2021
• Study Completion: December 24, 2021
• Last Updated: January 13, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)