Control of Myopia Using Novel Spectacle Lens Designs

Not Applicable

Active, not recruiting

• Conditions: Juvenile Myopia

• Registration Number: NCT03623074
• Lead Sponsor: SightGlass Vision, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-16
• Study First Submitted: 2018-08-03
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-09
• Primary Completion: 2022-05-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 266

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Spherical equivalent refraction	36 Months	Change in spherical equivalent refraction from baseline
Axial length	36 Months	Change in axial length from baseline

Trial Locations

Locations (14)

Golden Optometric Group; 🇺🇸 Whittier, California, United States

Sabal Eye Care; 🇺🇸 Longwood, Florida, United States

Visual Performance Center; 🇺🇸 Pensacola, Florida, United States

Kannarr Eye Care; 🇺🇸 Pittsburg, Kansas, United States

Eye Associates of Northeast Louisiana (DBA Haik Humble Eye Center) Research Dept; 🇺🇸 West Monroe, Louisiana, United States

Advanced Eyecare, PC; 🇺🇸 Raytown, Missouri, United States

SUNY School of Optometry; 🇺🇸 New York, New York, United States

Sacco Eye Group; 🇺🇸 Vestal, New York, United States

Dept of Clinical Research, South Shore Eye Care, LLP; 🇺🇸 Wantagh, New York, United States

Dunes Eye Consultants; 🇺🇸 Dakota Dunes, South Dakota, United States

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