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.
nthalmic Pty Ltd
210 participants
Dec 22, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria21
- Be between 6-14 years inclusive at time of enrolment.
- Have:
- Read the Informed Assent.
- Been explained the Informed Assent.
- Indicated an understanding of the Informed Assent.
- Signed the Informed Assent.
- Have their parent / legal guardian:
- Read the Informed Consent.
- Been explained the Informed Consent.
- Indicated an understanding of the Informed Consent.
- Signed the Informed Consent.
- Along with their parent / legal guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to study requirements.
- Along with their parent / legal guardian, agree to maintain the visit and prescribed wearing schedule.
- Agree to wear allocated spectacles for a minimum of 5 days per week, at least 6 hours per day for the duration of the study and to inform the investigator if their schedule is interrupted.
- Possess wearable and visually functioning spectacles.
- Be in good general health, based on the parent's / legal guardian's knowledge.
- Have best-corrected high contrast visual acuity based on manifest refraction of 0.10 logMAR (20/25, 6/7.6) or better in each eye.
- Meet the following criteria determined by cycloplegic autorefraction at Baseline:
- 00 D ≤ spherical equivalent ≤ -0.75 D and sphere component ≤ -0.50 DS.
- 50 DC ≤ astigmatic component ≤ 0 DC.
- \|Spherical equivalent anisometropia\| ≤ 1.00 D.
Exclusion Criteria35
- Participant is currently, or within 30 days prior to this study, has been an active participant in another study.
- Current or prior use of ANY form of myopia control, including but not limited to:
- Optical devices:
- Bifocal or multifocal spectacles of any type.
- Bifocal or multifocal contact lenses of any type.
- Orthokeratology of any type.
- Pharmacological agents:
- Atropine with a concentration > 0.01%. Participants who have previously used 0.01% atropine are eligible for this study provided they agree not to use 0.01% atropine for at least 30 days before baseline and at any time during the study.
- Pirenzepine
- Participant born earlier than 30 weeks or weighed < 1500 g at birth.
- A verbal report from the participant's parent / legal guardian is sufficient.
- Habitual use of a systemic or topical medication that may alter normal ocular findings / is known to affect a participant's ocular health / physiology either in an adverse or beneficial manner at enrolment and / or during the clinical trial.
- A known allergy to sodium fluorescein, benoxinate, proparacaine, tropicamide, or cyclopentolate.
- Strabismus as determined by cover test at distance (≥ 3 m) or near (40 cm) while wearing distance correction under non-cycloplegic conditions.
- Known ocular or systemic disease, such as but not limited to:
- Diabetes.
- Graves' disease.
- Glaucoma.
- Uveitis.
- Scleritis.
- Auto immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogrens syndrome, and systemic lupus erythematosus.
- Any ocular, systemic, or neuro-developmental conditions that could influence refractive development, such as but not limited to:
- Persistent pupillary membrane.
- Vitreous haemorrhage.
- Cataract.
- Central corneal scarring.
- Eyelid haemangiomas.
- Marfan's syndrome.
- Down's syndrome.
- Ehler's-Danlos syndrome.
- Stickler's syndrome.
- Ocular albinism.
- Retinopathy of prematurity.
- Keratoconus or irregular cornea.
- The investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant's best interests.
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Interventions
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
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06137560