Myopia Control With a Innovative Spectacle Lens

Clinical Evaluation of A Innovative Spectacle Lens in Slowing Myopia Progression

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

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: innovative myopia control spectacle lens; Device: Single vision spectacle lens

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92131
      • Scripps Poway Optometry
  • Florida
    • Longwood, Florida, United States, 32779
      • Sabal Eye Care
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Illinois College of Optometry
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • New England College of Optometry
  • New York
    • New York, New York, United States, 10036
      • SUNY College of Optometry
    • Vestal, New York, United States, 13850
      • Sacco Eye Group
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • UPMC Children's Hospital of Pittsburgh
  • Texas
    • Houston, Texas, United States, 77002
      • Mann Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Innovative myopia control spectacle lens	Device: innovative myopia control spectacle lens; using a innovative spectacle lens to control myopia progression
Placebo Comparator: Single vision spectacle lens	Device: Single vision spectacle lens; single vision spectacle lens for myopia and astigmatism correction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length	Change in axial length from baseline	36 Months
Cycloplegic spherical equivalent refraction	Change in cycloplegic spherical equivalent refraction from baseline	36 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length	Change in axial length from baseline	24 Months
Cycloplegic spherical equivalent refraction	Change in cycloplegic spherical equivalent refraction from baseline	24 Months

Collaborators and Investigators

• Sponsor: Essilor International

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2021
• Primary Completion (Actual): October 20, 2025
• Study Completion (Actual): October 20, 2025

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: December 13, 2021
• First Posted (Actual): January 3, 2022

Study Record Updates

• Last Update Posted (Estimated): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: myopia control; myopia; HAL; Stellest; spectacle; Essilor
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: WS10246

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No