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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
210
Standard single vision spectacle lens
Standard single vision spectacle lens + S.T.O.P.® Kit 1
Standard single vision spectacle lens + S.T.O.P.® Kit 2
Standard single vision spectacle lens + S.T.O.P.® Film
Standard single vision spectacle lens + S.T.O.P.® Kit 1 or 2
Tianjin Eye Hospital
Tianjin, Heping District, China
RECRUITINGShanghai Fudan University Eye and ENT Hospital
Shanghai, Xuhui District, China
RECRUITINGDivyajyoti Trust Tejas Eye Hospital
Surat, Gujarat, India
RECRUITINGLV Prasad Eye Institute
Hyderabad, Telangana, India
RECRUITINGPristine Eye Hospitals
Hyderabad, Telangana, India
NOT_YET_RECRUITINGAxial length
Difference in change from Baseline in axial length between single vision (control) and S.T.O.P.® Kit 1 \& 2 (tests)
Time frame: Baseline, First Dispense (up to 26 days from Baseline), then 1 month, 4 months, and 6 months after First Dispense
Axial length
Difference in change from Second Dispense in axial length between static optical cue (control) and dynamic optical cue (test)
Time frame: Second Dispense (up to 392 days from Baseline), then 6 months, 12 months, and 18 months after Second Dispense
Cycloplegic spherical equivalent autorefraction
Difference in change from Baseline in cycloplegic spherical equivalent autorefraction between single vision (control) and S.T.O.P.® Kit 1 \& 2 (tests)
Time frame: Baseline, First Dispense (up to 26 days from Baseline), then 1 month, 4 months, and 6 months after First Dispense
Cycloplegic spherical equivalent autorefraction
Difference in change from Second Dispense in cycloplegic spherical equivalent autorefraction between static optical cue (control) and dynamic optical cue (test)
Time frame: Second Dispense (up to 392 days from Baseline), then 6 months, 12 months, and 18 months after Second Dispense
Visual performance as measured by high contrast visual acuity at 6 m
Difference in visual performance between single vision (control) and S.T.O.P.® Kit 1 \& 2 (tests)
Time frame: 1 month, 4 months, and 6 months after First Dispense (up to 26 days from Baseline)
Visual performance as measured by high contrast visual acuity at 6 m
Difference in visual performance between static optical cue (control) and dynamic optical cue (test)
Time frame: 6 months, 12 months, and 18 months after Second Dispense (up to 392 days from Baseline)
Visual performance as measured by a non validated questionnaire based on a 1-10
Difference in visual performance between single vision (control) and S.T.O.P.® Kit 1 \& 2 (tests)
Time frame: 1 month, 4 months, and 6 months after First Dispense (up to 26 days from Baseline)
Visual performance as measured by a non validated questionnaire based on a 1-10
Difference in visual performance between static optical cue (control) and dynamic optical cue (test)
Time frame: 6 months, 12 months, and 18 months after Second Dispense (up to 26 days from Baseline)
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