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Myopia Progression Trial With Novel Myopia Control Design Spectacle Lenses

NCT04048148 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2021-01-28

No results posted yet for this study

Summary

This is a mono-center, randomized, double-masked, cross-over study to evaluate rate of myopia progression with novel designed myopia control lens (test) compared to SVL (control). A total of 120 children will be recruited where 60 participants each will be randomized either to wear test (Group 1) or SVL lenses (Group 2) for 6 months each. At the end of the 6 months period, there will be a cross- over of lenses and the lenses evaluated for a further 6 months. At the end of the 12 month period, all participants (Group 1 and Group 2) will wear test lenses for another 6 months.

Conditions

  • Myopia

Interventions

DEVICE

Novel designed myopia control spectacle lenses

A novel designed myopia control spectacle lenses (test lenses) will be given to both arms to wear for 12 months.

Sponsors & Collaborators

  • Essilor International

    collaborator INDUSTRY

  • Hai Yen Eye Care

    collaborator INDUSTRY

  • Brien Holden Vision Institute

    lead OTHER

Principal Investigators

  • Padmaja Sankaridurg, PhD · Brien Holden Vision Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2021-04-30
Completion
2021-05-31

Countries

  • Vietnam

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 NCT04048148 on ClinicalTrials.gov