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CompletedNCT05684302Updated Jan 13, 2023

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

An observational study in Myopia and Refractive Errors, sponsored by Tianjin Eye Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-01-13.

Sponsored by Tianjin Eye Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 50 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Myopia
  • Refractive Errors

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03

In context

Refractive Errors

413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's enrollment of 200 is above the median of 150 across 107 observational studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

Tianjin Eye Hospital is the lead sponsor of 49 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Healthy myopic people between 18 and 50 years of age

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

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.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No

Interventions

  • OtherThe free-toroidal design lenses

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

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What researchers measure

Primary outcomes

  1. The clarity score

    The clarity score by a questionnaire,scores on the questionnaire range from 1 to 6, with higher scores being better

    Time frame: baseline visit time

  2. The comfort score

    The comfort score by a questionnaire,scores on the questionnaire range from 1 to 6, with higher scores being better

    Time frame: baseline visit time

Secondary outcomes

  1. Accuracy of foveal and peripheral visual acuity

    Accuracy of foveal and peripheral visual acuity was assessed by the eye movement tracking device

    Time frame: baseline visit time

07

Study locations

1 site
  • Tianjin Eye Hospital
    Tianjin, China
08

References and documents

Publications

  • Jalie M. Modern spectacle lens design. Clin Exp Optom. 2020 Jan;103(1):3-10. doi: 10.1111/cxo.12930. Epub 2019 Jun 20. PubMed 31222837 ↗
  • Gannon C, Liang R. Evolving expertise for automated lens optimization. Appl Opt. 2020 Aug 1;59(22):G129-G136. doi: 10.1364/AO.391888. PubMed 32749325 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05684302
Lead sponsor
Tianjin Eye Hospital
Responsible party
Sponsor
First posted
Jan 13, 2023
Start date
Jan 1, 2021
Primary completion
Dec 24, 2021
Completion
Dec 24, 2021
Last update
Jan 13, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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