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Completed

NCT Number: NCT05684302

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

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Eye Hospital

Tianjin, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The free-toroidal design lenses

Other

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

Primary outcomes

  1. The clarity score

    Time frame: 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

    Time frame: baseline visit time

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

Secondary outcomes

  1. Accuracy of foveal and peripheral visual acuity

    Time frame: baseline visit time

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

Sponsors and collaborators

Lead sponsor

Tianjin Eye Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 13, 2023
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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