Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT06137560
Eligibility Criteria:
Inclusion Criteria:
* 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:
* -5.00 D ≤ spherical equivalent ≤ -0.75 D and sphere component ≤ -0.50 DS.
* -1.50 DC ≤ astigmatic component ≤ 0 DC.
* \|Spherical equivalent anisometropia\| ≤ 1.00 D.
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
14 Years
Study:
NCT06137560
Study Brief:
Protocol Section:
NCT06137560