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New treatment option for Myopia
Official title The A.R.R.E.S.T.® Contact Lens Study
ClinicalTrials.gov ID: NCT06878118
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if contact lenses using Active Reconfiguration in Retinal Encoding of Spatio-Temporal (A.R.R.E.S.T.®) signal technology works to slow down the rate of myopia progression compared to single vision contact lenses in myopic children. The main questions it aims to answer are: Do contact lenses using A.R.R.E.S.T.® technology slow down the rate of axial length growth?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 15
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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...
- 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.
What rules you out
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Wenzhou, Zhejiang, China
- Kuala Lumpur, Malaysia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 15 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wenzhou, Zhejiang, China; Kuala Lumpur, Malaysia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.