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

Clinical Evaluation of Vision Performance of the FIN C2 Lens

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07668102
Acronym
FIN-3102
Enrollment
88
Registered
2026-06-25
Start date
2024-05-22
Completion date
2024-10-20
Last updated
2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Brief 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.

Interventions

DEVICEHAL spectacle lens

HAL spectacle lens for myopia control

Single vision spectacle lens for myopia and astigmatism correction

Sponsors

Essilor International
Lead SponsorINDUSTRY
Visioncare Research Ltd.
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
Reading SpeedBetween Year 1 and Year 2 of the WS10246 study, representing an average timeframe of 1.5 years into the parent study.Reading speed (mean words per minute) collected using the Wolffsohn Research iPad OptomCentral App

Secondary

MeasureTime frameDescription
Binocular distance high contrast visual acuity (VA) through the lens peripheryBetween Year 1 and Year 2 of the WS10246 study, representing an average timeframe of 1.5 years into the parent study.Measured to the nearest letter using a standard ETDRS chart at 4 meters.
Binocular photopic near contrast sensitivity function (CSF)Between Year 1 and Year 2 of the WS10246 study, representing an average timeframe of 1.5 years into the parent study.Evaluated at 40 cm using the iPad OptomCentral App across various spatial frequencies to calculate the Area Under the Log Contrast Sensitivity Function (AULCSF).

Countries

United States

Contacts

STUDY_DIRECTORJason Shen, PhD

Essilor International, Affiliation of EssilorLuxottica

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026