RecruitingNot ApplicableNCT06137560

Spectacle Films Utilising S.T.O.P.® Technology for Slowing Down Myopia Progression in Children

Spectacle Films Utilising S.T.O.P.® Technology for Slowing Down Myopia Progression in Children: A Prospective, Masked, Controlled, Randomised, Clinical Trial.

Sponsor

nthalmic Pty Ltd

Enrollment

210 participants

Start Date

Dec 22, 2023

Study Type

INTERVENTIONAL

Conditions

Myopia

Summary

There are two parts to this trial. First, to compare the rate of myopia progression of spectacle films using Spatio Temporal Optic Phase (S.T.O.P.®) technology that provide a dynamic optical cue against single vision spectacle lenses. Second, to compare the rate of myopia progression of spectacle films using S.T.O.P.® technology that provide a dynamic optical cue against spectacle films using S.T.O.P.® technology that provide a static optical cue. A dynamic optical cue is one that changes, and a static optical cue is one that does not change.

Eligibility

Min Age: 6 YearsMax Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Single vision spectacle lens, a medical device called Single vision spectacle lens + S.T.O.P.® Film, and others for people with myopia. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 6 Years to 14 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESingle vision spectacle lens

Standard single vision spectacle lens

DEVICESingle vision spectacle lens + S.T.O.P.® Kit 1

Standard single vision spectacle lens + S.T.O.P.® Kit 1

DEVICESingle vision spectacle lens + S.T.O.P.® Kit 2

Standard single vision spectacle lens + S.T.O.P.® Kit 2

DEVICESingle vision spectacle lens + S.T.O.P.® Film

Standard single vision spectacle lens + S.T.O.P.® Film

DEVICEStandard single vision spectacle lens + S.T.O.P.® Kit 1 or 2

Standard single vision spectacle lens + S.T.O.P.® Kit 1 or 2

Locations(5)

Tianjin Eye Hospital

Tianjin, Heping District, China

Shanghai Fudan University Eye and ENT Hospital

Shanghai, Xuhui District, China

Divyajyoti Trust Tejas Eye Hospital

Surat, Gujarat, India

LV Prasad Eye Institute

Hyderabad, Telangana, India

Pristine Eye Hospitals

Hyderabad, Telangana, India

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06137560

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