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OpenTrials
Completed

NCT Number: NCT03761758

Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast

Prospective, randomized, subject-masked 3-arm clinical study to assess the pediatric acceptability across three iterations of a novel spectacle lens design.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Ocular Research & Education

Waterloo, Ontario, N2L 3G1, Canada

About this study

This feasibility study was conducted to assess the performance of three experimental spectacle lens designs (spectacle lenses) in children between 6 and 9 years of age with myopia.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Ages between 6 and 12 years
  • Myopia between -1.00 and -4.00 D

Exclusion criteria

  • Participating in any clinical or other research study
  • Contact lens wearer

Treatment and study plan

Spectacle lenses

Device

Spectacle lenses with clear central apertures

Primary outcomes

  1. Distance Visual Acuity

    Time frame: 2 weeks

    Measurement of best corrected distance visual acuity

  2. Contrast Sensitivity

    Time frame: 2 weeks

    Measurement of contrast sensitivity

  3. Subjective Responses

    Time frame: 2 weeks

    Assessment of subject responses related to wear time of spectacles

Sponsors and collaborators

Lead sponsor

SightGlass Vision, Inc.

Industry

Registry information

Acronym: WALNUT

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 3, 2018
Registry last updated
Dec 3, 2018

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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