Myopia Control With a Innovative Spectacle Lens
Completed · Not applicable
Conditions studied: Myopia
In brief
The purpose of this study is to demonstrate that the test spectacle lens is safe and effective in slowing myopia progression in children.
Key facts
- Study ID
- NCT05174780
- Run by
- Essilor International
- People needed
- 159
- Starts
- 2021-12-29
- Expected to finish
- 2025-10-20
- Last updated by the study team
- 2025-12-22
Who can join
Age: 6 and older, up to 12. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Scripps Poway Optometry — San Diego, California, United States
- Sabal Eye Care — Longwood, Florida, United States
- Illinois College of Optometry — Chicago, Illinois, United States
- Kannarr Eye Care — Pittsburg, Kansas, United States
- New England College of Optometry — Boston, Massachusetts, United States
- SUNY College of Optometry — New York, New York, United States
- Sacco Eye Group — Vestal, New York, United States
- UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
- Mann Eye Institute — Houston, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.