Spectacle Films Utilising S.T.O.P.® Technology for Slowing Down Myopia Progression in Children
NCT06137560 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210
Last updated 2025-04-17
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.
Conditions
- Myopia
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
Sponsors & Collaborators
-
Zhong Jing Wei Shi (Suzhou) Optical Technology Ltd.
collaborator UNKNOWN -
nthalmic Pty Ltd
lead NETWORK
Principal Investigators
-
Daniel Tilia, Optom, PhD · nthalmic Pty Ltd
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 14 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-22
- Primary Completion
- 2026-09-30
- Completion
- 2026-09-30
Countries
- China
- India
Study Locations
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