NCT06137560

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: nthalmic Pty Ltd · Network
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In the first part of the trial, myopic children (6-14 years of age) will be randomly allocated to wear one of three spectacle lens options (standard single vision spectacle lenses, standard single vision spectacle lenses + S.T.O.P.® Kit 1 spectacle films, or standard single vision spectacle lenses + S.T.O.P.® Kit 2 spectacle films). S.T.O.P.® spectacle films are applied to the front surface of standard single vision spectacle lenses. Both S.T.O.P.® Kits 1 and 2 are comprised of two different sets of spectacle films applied to two different pairs of single vision spectacle lenses which are worn on alternate weeks, and thus both S.T.O.P.® Kits 1 and 2 provide a dynamic optical cue. In the second part of this trial, participants will be randomly allocated wear of of two spectacle lens options (the best performer from S.T.O.P.® Kits 1 and 2 in terms of reducing the rate of myopic progression and single vision spectacle lenses + S.T.O.P.® film). As previously stated, both S.T.O.P.® Kits 1 and 2 provide a dynamic optical cue while S.T.O.P.® film provide a static optical cue. The overall trial duration, including follow-up period, is expected to be approximately 42 months. Each participant's duration is expected to be approximately 30 months. The visits are Baseline, Dispensing, 1 month, 4 months, 6 months, then visits every 6 months after. All procedures performed at these visits are standard, non invasive clinical tests.

Conditions

• Myopia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-12-22
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2023-11-18
• Last updated: 2025-04-17

Locations

5 sites across 2 countries: China, India