Controlling myopia in young children with a new type of glasses

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Jennifer S Hill, BS
• Email: jhill@sightglassvision.com
• Phone: 678-361-4877

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Where children look through their glasses

  This trial tests how children ages 7–14 look through a new spectacle lens design to see which parts of the lens they use during different tasks.

  Recruiting SightGlass Vision, Inc. · Bloomington, Indiana · NCT07229365

• Children wearing spectacle lenses: mobility during everyday activities

  This test checks whether myopia-control spectacle lenses change how children aged 6–12 move and perform everyday mobility tasks compared with regular single-vision glasses.

  Recruiting SightGlass Vision, Inc. · Glendale, Arizona · NCT07229352

• Optimizing light exposure to prevent and control myopia in children

  This study tests if changing classroom lighting to mimic sunlight or using a smartphone app to guide light exposure can help prevent and control myopia in primary school children.

  Recruiting at 5 sites National University of Singapore · Singapore and 4 other locations · NCT06631339

• Using DIMS Glasses to See if Myopia Progression Slows in Kids

  This observational study tests whether wearing DIMS glasses in children and teens with myopia can slow progression, considering factors like outdoor time and family history.

  Recruiting Semmelweis University · Budapest · NCT07698977

• Continued use of DOT spectacle lenses for Chinese children

  This will test whether DOT spectacle lenses slow myopia progression over 12 months in Chinese children who completed the earlier CATHAY study.

  Recruiting at 4 sites SightGlass Vision, Inc. · Changsha and 4 other locations · NCT07008001

• Evaluating a device for screening vision problems in young children

  This study is testing a new device to see if it can effectively find vision problems in children aged 3 to 8, whether they wear glasses or not.

  Recruiting Essilor International · Nancy, France and 1 other locations · NCT06882408

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.