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

Sponsor
Tianjin Eye Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05684302
Collaborator
(none)
200
Enrollment
1
Location
11.7
Actual Duration (Months)
17.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: The free-toroidal design lenses

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 Design

Study Type:
Observational
Actual Enrollment :
200 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
The Effect of the Free-toroidal Design Lenses on the Subjective Visual Quality in the Myopic Population
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Dec 24, 2021
Actual Study Completion Date :
Dec 24, 2021

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tianjin Eye Hospital Tianjin China

Sponsors and Collaborators

  • Tianjin Eye Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Tianjin Eye Hospital
ClinicalTrials.gov Identifier:
NCT05684302
Other Study ID Numbers:
  • KY202101
First Posted:
Jan 13, 2023
Last Update Posted:
Jan 13, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Refractive Errors

Study Results

No Results Posted as of Jan 13, 2023