Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 11:59 PM
Study NCT ID:
NCT06137560
Status:
RECRUITING
Last Update Posted:
2025-04-17
First Post:
2023-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spectacle Films Utilising S.T.O.P.® Technology for Slowing Down Myopia Progression in Children
Sponsor:
nthalmic Pty Ltd
Organization:
Study Overview
Official Title:
Spectacle Films Utilising S.T.O.P.® Technology for Slowing Down Myopia Progression in Children: A Prospective, Masked, Controlled, Randomised, Clinical Trial.
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: