Visual Performance of Highly Aspherical Lenslet Spectacles in Children (Ancillary to WS10246)
FIN-3102
Clinical Evaluation of Vision Performance of the FIN C2 Lens
1 other identifier
interventional
88
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2024
Shorter than P25 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2024
CompletedFirst Submitted
Initial submission to the registry
June 15, 2026
CompletedFirst Posted
Study publicly available on registry
June 25, 2026
CompletedJune 25, 2026
June 1, 2026
4 months
June 15, 2026
June 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Reading Speed
Reading speed (mean words per minute) collected using the Wolffsohn Research iPad OptomCentral App
Between Year 1 and Year 2 of the WS10246 study, representing an average timeframe of 1.5 years into the parent study.
Secondary Outcomes (2)
Binocular distance high contrast visual acuity (VA) through the lens periphery
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)
Between Year 1 and Year 2 of the WS10246 study, representing an average timeframe of 1.5 years into the parent study.
Study Arms (2)
HAL spectacle lens
EXPERIMENTALHAL spectacle lens using a innovative spectacle lens to control myopia progression
Single vision spectacle lens
PLACEBO COMPARATORSingle vision spectacle lens for myopia and astigmatism correction
Interventions
Single vision spectacle lens for myopia and astigmatism correction
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Current ocular infection, inflammation, or irritation likely to affect vision.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Essilor Internationallead
- Visioncare Research Ltd.collaborator
Study Sites (7)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jason Shen, PhD
Essilor International, Affiliation of EssilorLuxottica
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2026
First Posted
June 25, 2026
Study Start
May 22, 2024
Primary Completion
September 20, 2024
Study Completion
October 20, 2024
Last Updated
June 25, 2026
Record last verified: 2026-06