Tolerability of a Novel Spectacle Design With Reduced Peripheral Contrast

SightGlass Vision, Inc.21 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

SINGLE

Enrollment

Conditions

Myopia

Interventions

Spectacle lensesDEVICE

Spectacle lenses with clear central apertures

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Centre for Ocular Research & Education

Waterloo, Ontario, Canada

Outcomes

Primary Outcomes

Distance Visual Acuity

Measurement of best corrected distance visual acuity

Time frame: 2 weeks

Contrast Sensitivity

Measurement of contrast sensitivity

Time frame: 2 weeks

Subjective Responses

Assessment of subject responses related to wear time of spectacles

Time frame: 2 weeks

Data from ClinicalTrials.gov

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