Visual Performance of Highly Aspherical Lenslet Spectacles in Children (Ancillary to WS10246)

Essilor International88 enrolled

Overview

To evaluate the visual performance of (high and low contrast distance visual acuity, reading speed, near visual acuity, and near contrast sensitivity) of HAL spectacle lenses (habitual correction) in comparison with single vision control lenses.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Myopia

Interventions

HAL spectacle lensDEVICE

HAL spectacle lens for myopia control

Single Vision spectacle lensDEVICE

Single vision spectacle lens for myopia and astigmatism correction

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Existing subjects from Essilor R\&D Study WS10246 clinical study. * Ability to comply with study procedures. * Informed consent of parent/guardian and assent of subject. Exclusion Criteria: * Current ocular infection, inflammation, or irritation likely to affect vision.

Locations (7)

Scripps Poway Optometry

San Diego, California, United States

Sabal Eye Care

Longwood, Florida, United States

Illinois College of Optometry

Chicago, Illinois, United States

Kannarr Eye Care

Pittsburg, Kansas, United States

Outcomes

Primary Outcomes

Reading Speed

Reading speed (mean words per minute) collected using the Wolffsohn Research iPad OptomCentral App

Time frame: Between Year 1 and Year 2 of the WS10246 study, representing an average timeframe of 1.5 years into the parent study.

Secondary Outcomes

Binocular distance high contrast visual acuity (VA) through the lens periphery

Measured to the nearest letter using a standard ETDRS chart at 4 meters.

Time frame: Between Year 1 and Year 2 of the WS10246 study, representing an average timeframe of 1.5 years into the parent study.

Binocular photopic near contrast sensitivity function (CSF)

Evaluated at 40 cm using the iPad OptomCentral App across various spatial frequencies to calculate the Area Under the Log Contrast Sensitivity Function (AULCSF).

Time frame: Between Year 1 and Year 2 of the WS10246 study, representing an average timeframe of 1.5 years into the parent study.

Data from ClinicalTrials.gov

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