CClinicalTrials.gg
CompletedNCT07668102FIN-3102Updated Jun 25, 2026

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

An interventional study of HAL spectacle lens and Single Vision spectacle lens in Myopia, sponsored by Essilor International. Completed at 7 sites in United States. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by Essilor International · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Sep 2024, 2 years ago, and no results have been posted to the registry.
  • Registered 2 years after the study started (first participant enrolled May 2024, registered Jun 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Myopia

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03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 88 is close to the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Essilor International is the lead sponsor of 38 studies on the registry; 20 are open to participants now.

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

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Current ocular infection, inflammation, or irritation likely to affect vision.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
88 participants (actual)

Study arms

  • Experimental
    HAL spectacle lens

    HAL spectacle lens using a innovative spectacle lens to control myopia progression

    Device: HAL spectacle lens

  • Placebo comparator
    Single vision spectacle lens

    Single vision spectacle lens for myopia and astigmatism correction

    Device: Single Vision spectacle lens

Interventions

  • DeviceHAL spectacle lens

    HAL spectacle lens for myopia control

  • DeviceSingle Vision spectacle lens

    Single vision spectacle lens for myopia and astigmatism correction

06

What researchers measure

Primary outcomes

  1. 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

  1. 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.

  2. 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.

07

Study locations

7 sites
  • Scripps Poway Optometry
    San Diego, California 92131, United States
  • Sabal Eye Care
    Longwood, Florida 32779, United States
  • Illinois College of Optometry
    Chicago, Illinois 60616, United States
  • Kannarr Eye Care
    Pittsburg, Kansas 66762, United States
  • New England College of Optometry
    Boston, Massachusetts 02115, United States
  • SUNY College of Optometry
    New York, New York 10036, United States
  • Sacco Eye Group
    Vestal, New York 13850, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07668102
Lead sponsor
Essilor International
Collaborators
Visioncare Research Ltd.
Responsible party
Sponsor
First posted
Jun 25, 2026
Start date
May 22, 2024
Primary completion
Sep 20, 2024
Completion
Oct 20, 2024
Last update
Jun 25, 2026

Study contacts

Jason Shen, PhD
study director · Essilor International, Affiliation of EssilorLuxottica

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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