Active — Not RecruitingNot Applicable

Control of Myopia Using Novel Spectacle Lens Designs

United States266 participantsStarted 2018-07-16

Plain-language summary

Randomized, controlled, multisite, subject-and observer-masked, 3-arm parallel group clinical trial of 36-month duration to evaluate the safety and efficacy of a novel spectacle lens design in reducing the progression of juvenile myopia.

Who can participate

Age range6 Years – 10 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children 6-10 years of age (day prior to 10th birthday) at time of informed consent/assent * SER error between -0.75 and -4.50 D * SER power between the two eyes must be less than or equal to 1.50 D * Willingness to participate in the trial for 3 years without content lens wear Exclusion Criteria: * Previous or current use of contact lenses * Previous or current use of bifocals, progressive addition spectacles lenses * Previous or current use of myopia control treatment * Astigmatism worse then -1.25 DC in either eye

What they're measuring

Axial length

Timeframe: 36 Months

Spherical equivalent refraction

Timeframe: 36 Months

Trial details

NCT IDNCT03623074

SponsorSightGlass Vision, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-15

View on ClinicalTrials.gov More Juvenile Myopia trials