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Myopia Assessment of Two Manufacturing Processes

NCT04126057 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-01-25

Study results available
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Summary

Randomized, controlled, multisite, subject- and observer-masked, contralateral clinical trial of 6-month duration to compare two SightGlass Vision Diffusion Optics Technology (DOT) spectacle lens manufacturing processes in reducing the progression of juvenile myopia.

Conditions

  • Juvenile Myopia

Interventions

DEVICE

SightGlass Vision DOT Spectacle Lenses

Subjects randomized to test vs control, left eyes and right eyes

Sponsors & Collaborators

  • SightGlass Vision, Inc.

    lead INDUSTRY

Principal Investigators

  • Joseph Rappon, OD, MS, FAAO · SightGlass Vision, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-02
Primary Completion
2020-09-15
Completion
2020-09-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04126057 on ClinicalTrials.gov