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RECRUITING
NCT06137560
NA

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

Sponsor: nthalmic Pty Ltd

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

6 Years - 14 Years

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2023-12-22

Completion Date

2026-09

Last Updated

2025-04-17

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Single vision spectacle lens

Standard single vision spectacle lens

DEVICE

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

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

DEVICE

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

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

DEVICE

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

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

DEVICE

Standard 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