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OpenTrials
Completed

NCT Number: NCT05174780

Myopia Control With a Innovative Spectacle Lens

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

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scripps Poway Optometry, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

innovative myopia control spectacle lens

Device

using a innovative spectacle lens to control myopia progression

Single vision spectacle lens

Device

single vision spectacle lens for myopia and astigmatism correction

Primary outcomes

  1. Axial length

    Time frame: 36 Months

    Change in axial length from baseline

  2. Cycloplegic spherical equivalent refraction

    Time frame: 36 Months

    Change in cycloplegic spherical equivalent refraction from baseline

Secondary outcomes

  1. Axial length

    Time frame: 24 Months

    Change in axial length from baseline

  2. Cycloplegic spherical equivalent refraction

    Time frame: 24 Months

    Change in cycloplegic spherical equivalent refraction from baseline

Sponsors and collaborators

Lead sponsor

Essilor International

Industry

Registry information

Official study title

Clinical Evaluation of A Innovative Spectacle Lens in Slowing Myopia Progression

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 3, 2022
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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