Myopia Control With a Innovative Spectacle Lens

NCT ID: NCT05174780

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-29

Study Completion Date

2025-10-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to demonstrate that the test spectacle lens is safe and effective in slowing myopia progression in children.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

spectacle myopia control myopia HAL Stellest Essilor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Innovative myopia control spectacle lens

Group Type EXPERIMENTAL

innovative myopia control spectacle lens

Intervention Type DEVICE

using a innovative spectacle lens to control myopia progression

Single vision spectacle lens

Group Type PLACEBO_COMPARATOR

Single vision spectacle lens

Intervention Type DEVICE

single vision spectacle lens for myopia and astigmatism correction

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

innovative myopia control spectacle lens

using a innovative spectacle lens to control myopia progression

Intervention Type DEVICE

Single vision spectacle lens

single vision spectacle lens for myopia and astigmatism correction

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Equal to or greater than 6 years and not older than 12 years at time of informed consent and assent.
* Spherical equivalent refractive error (SER) by manifest refraction between -0.75 and -4.50 D in each eye.
* Astigmatism, if present, of not more than 1.50 D.
* Difference in SER between the two eyes (Anisometropia) by manifest refraction not more than 1.00 D.
* Best corrected visual acuity in each eye equal to or better than +0.10 logMAR (≥ 20/25 as Snellen)
* Agree to wear spectacles for ≥10 hours/day at least 6 days/week.
* Willingness and ability to participate in trial for 3 years and attend scheduled visits.

Exclusion Criteria

* History of myopia control intervention (e.g., atropine, orthokeratology, multifocal contact lenses, etc.)
* Strabismus by cover test at near or distance wearing correction.
* Amblyopia
* Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down's syndrome, etc.).
* Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state.
* Current or anticipated use of growth hormones.
* Participation in any clinical study within 30 days of the Baseline visit.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Essilor International

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Scripps Poway Optometry

San Diego, California, United States

Site Status

Sabal Eye Care

Longwood, Florida, United States

Site Status

Illinois College of Optometry

Chicago, Illinois, United States

Site Status

Kannarr Eye Care

Pittsburg, Kansas, United States

Site Status

New England College of Optometry

Boston, Massachusetts, United States

Site Status

SUNY College of Optometry

New York, New York, United States

Site Status

Sacco Eye Group

Vestal, New York, United States

Site Status

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Mann Eye Institute

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WS10246

Identifier Type: -

Identifier Source: org_study_id