Control of Myopia Using Novel Spectacle Lens Designs

N/AActive Not RecruitingNCT03623074

SightGlass Vision, Inc.266 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

266

Conditions

Juvenile Myopia

Interventions

Novel spectacle lens designDEVICE

Use of lenses may reduce the rate of progression of juvenile myopia

Spectacle lensesDEVICE

Use of lenses may reduce the rate of progression of juvenile myopia

Eligibility

Sex: ALLMin age: 6 YearsMax age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (14)

Golden Optometric Group

Whittier, California, United States

Sabal Eye Care

Longwood, Florida, United States

Visual Performance Center

Outcomes

Primary Outcomes

Axial length

Change in axial length from baseline

Time frame: 36 Months

Spherical equivalent refraction

Change in spherical equivalent refraction from baseline

Time frame: 36 Months

Data from ClinicalTrials.gov

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