Controlling myopia in young children with a new type of glasses

Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens

This study is testing a new type of glasses to see if they can help control the worsening of nearsightedness in children aged 6 to 8 years.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 6 Years to 8 Years
• Sex: All
• Sponsor: SightGlass Vision, Inc. (Industry-sponsored)
• Locations: 14 sites (Oakland, California and 13 other locations)
• Trial ID: NCT06034327 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of a novel spectacle lens designed to control myopia progression in children aged 6 to 8 years. It is a randomized, controlled trial with two groups: one receiving the new spectacle lenses and the other receiving standard lenses. The study will assess the efficacy over a 12-month period, with results used to predict long-term treatment outcomes over three years. Participants will be required to wear the assigned spectacles for a minimum of 10 hours daily, and various eye measurements will be taken to monitor progress.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 6 to 8 years with specific refractive errors and visual acuity requirements.

Not a fit: Patients with refractive errors outside the specified range or those unable to comply with the spectacle wear requirements may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective method for managing myopia in young children, potentially reducing the risk of severe vision problems later in life.

How similar studies have performed: Previous studies have shown promise in using specialized lenses for myopia control, making this approach a continuation of ongoing research in this area.

Eligibility criteria

Inclusion Criteria:

1. Children 6 - 8 years of age (inclusive) at time of informed consent/assent;
2. Spherical equivalent refractive error between -0.75 and -4.50 D inclusive (by manifest refraction) in each eye;
3. Astigmatism if present, less than or equal to -1.25 DC (by manifest refraction) in each eye;
4. Best corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye;
5. The difference in spherical equivalent power between the two eyes (anisometropia based on manifest refraction) must be less than or equal to 1.50 D;
6. Agree to wear the assigned spectacles constantly except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible (minimum of 10 hours per day);
7. Ability to comply with study procedures, including high and low contrast visual acuity, axial length, and cycloplegic autorefraction measurements taken for both eyes at the baseline visit;
8. Willingness to participate in the trial for 24 months without contact lens wear;
9. The subject's parent(s) or legal guardian(s) must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.

Exclusion Criteria:

1. Subject has previously or currently wears contact lenses (greater than 1-month usage);
2. Current or prior use of bifocals, progressive addition spectacle lenses
3. Current or prior use of any myopia control treatment (e.g., atropine, multifocal contact lenses, orthokeratology);
4. Amblyopia in either eye;
5. Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction;
6. Any ocular or systemic conditions that could influence refractive development or status \[e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfan syndrome or other connective tissue disorder, Down's syndrome, family history of poor night vision (to prevent against enrolling subjects with congenital stationary night blindness)\];
7. Known allergy to proparacaine, tetracaine, or tropicamide;
8. Participation in any investigational clinical study within 30 days of the Baseline visit;
9. Subject's sibling or other household member is already enrolled in this trial.

Where this trial is running

Oakland, California and 13 other locations

• Elsa Pao, OD — Oakland, California, United States (Recruiting)
• Scripps Poway Eyecare — San Diego, California, United States (Recruiting)
• Pacific Rims Optometry — San Francisco, California, United States (Recruiting)
• Paje Optometric — Santa Ana, California, United States (Recruiting)
• Omega Vision Center — Longwood, Florida, United States (Recruiting)
• Marietta Eye Clinic — Marietta, Georgia, United States (Recruiting)
• Ilinois College of Optometry — Chicago, Illinois, United States (Recruiting)
• Kannarr Eye Care — Pittsburg, Kansas, United States (Recruiting)
• New England College of Optometry — Boston, Massachusetts, United States (Recruiting)
• Advanced Eyecare PC — Raytown, Missouri, United States (Recruiting)
• Athens Eye Care — Athens, Ohio, United States (Recruiting)
• Procare Vision Centers, Inc. — Granville, Ohio, United States (Recruiting)
• Texas State Optical - Dowlen — Beaumont, Texas, United States (Recruiting)
• Bellaire Family Eye Care — Bellaire, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Jennifer S Hill, BS

Conditions Myopia; Juvenile Myopia; Myopia Progression