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

Part of paid clinical trials in San Diego, California.

Sponsor
Essilor International
Study ID
NCT07668102
Status
Completed

Conditions

  • Myopia

Eligibility Criteria

Sex
ALL
Age
6 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • HAL spectacle lens — DEVICE
    HAL spectacle lens for myopia control
  • Single Vision spectacle lens — DEVICE
    Single vision spectacle lens for myopia and astigmatism correction

Study Details

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.

Key Dates

Start date
May 22, 2024
Status verified
Jun 2026
Primary completion
Sep 20, 2024
Completion
Oct 20, 2024

Study Design

Enrollment
88 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HAL spectacle lens
    HAL spectacle lens using a innovative spectacle lens to control myopia progression
  • Placebo Comparator: Single vision spectacle lens
    Single vision spectacle lens for myopia and astigmatism correction

Primary Outcome Measure

Reading Speed [ Time Frame: Between Year 1 and Year 2 of the WS10246 study, representing an average timeframe of 1.5 years into the parent study. ]

Locations (7)

FacilityCityStateZIPSite coordinators
Scripps Poway OptometrySan DiegoCalifornia92131-
Sabal Eye CareLongwoodFlorida32779-
Illinois College of OptometryChicagoIllinois60616-
Kannarr Eye CarePittsburgKansas66762-
New England College of OptometryBostonMassachusetts02115-
SUNY College of OptometryNew YorkNew York10036-
Sacco Eye GroupVestalNew York13850-

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