New contact lens tech aims to slow Kids' nearsightedness
NCT ID NCT06878118
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This study tests whether contact lenses with A.R.R.E.S.T.® technology can slow the progression of myopia (nearsightedness) in children compared to standard single-vision lenses. About 80 children aged 7 to 15 will wear either the special or standard lenses for 12 months, with seven clinic visits to measure eye growth and vision changes. The goal is to see if the new lenses can reduce how quickly the eye lengthens and nearsightedness increases.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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7 to 15 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria * Be between 7 to 15 years old 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 to adhere to the study requirements. * Along with their parent/legal guardian, agree to maintain the visit and prescribed wearing schedule. * Agree to wear the study contact lenses for a minimum of 5 days/week, 6 hours/day on days lenses are worn but not \> 16 hours per day, and to remove lenses at night (i.e., daily wear only with no contact lens wear during sleep), for the duration of the study and to inform the investigator if their schedule is interrupted. Wearing time can be modified by the investigator for health reasons. * Be in good general health, based on parent's/legal guardian's knowledge. * Have best-corrected high contrast visual acuity of 0.10 logMAR (Snellen: 20/25, 6/7.6; Decimal: 0.80) or better in each eye. * Meet the following criteria determined by cycloplegic autorefraction at Baseline: * -4.00 D ≤ spherical equivalent ≤ 0.75 D * -1.00 DC ≤ astigmatic component ≤ 0 DC * Participants who fail astigmatism criterion with autorefraction pass astigmatism criterion if ≥ 0.75 D is measured with subjective refraction. * \|Spherical equivalent anisometropia\| ≤ 1.00 D. Exclusion Criteria * Participant in another study within 30 days prior to this study. * Current or prior use of interventions intended for myopia control, including but not limited to: * Optical devices: * Bifocal / multifocal spectacles. * Bifocal / multifocal contact lenses. * Orthokeratology. * 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. o 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. * A known corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, ocular viral or fungal infections, or any other recurrent ocular infections. * 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. * Biomicroscopic that contraindicate contact lens, such as but not limited to: * Neovascularisation or ghost vessels ≥ 1.5 mm in from limbus. * Any active anterior segment disease that contraindicates safe contact lens wear. * Clinically significant giant papillary conjunctivitis. * Clinically significant abnormalities of the anterior segment, lids, conjunctiva, sclera, or associated structures. * Allergic or seasonal conjunctivitis if the investigator believes it could significantly interfere with maintaining a specified wearing schedule. * 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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Optometry Clinic, Faculty of Health Science, Universiti Kebangsaan Malaysia
Kuala Lumpur, 50300, Malaysia
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Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
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Other studies related to the condition(s) this trial covers.
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- Can glasses that slow nearsightedness also reshape a Child's astigmatism?