Prospective, Controlled, Randomised, Contralateral Wear, Dispensing Trial to Assess the Efficacy of Contact Lenses Using A.R.R.E.S.T.® Technology
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Cycloplegic spherical equivalent autorefraction
研究概览
简要总结
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? Do contact lenses using A.R.R.E.S.T.® technology slow down the rate of increase in myopic refractive error?
Researchers will compare contact lenses using A.R.R.E.S.T.® technology to a single vision contact lens.
Participants will:
Be randomly allocated to wear either contact lenses using A.R.R.E.S.T.® technology or single vision contact lenses.
Visit the clinic on seven occasions over a 12 month period.
详细描述
The aim of this clinical trial is to compare the rate of myopia progression as measured by change from dispensing, in axial length and the change from Baseline in the spherical equivalent cycloplegic autorefraction between a contact lens using A.R.R.E.S.T.® technology (test) and a single vision contact lens (control). Myopic children (7-15 years of age) will be randomly allocated to wear either test or control.
The overall trial duration, including follow-up period, is expected to be approximately 18 months. Each participant's duration is expected to be approximately 12 months.
The visits are Baseline, 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months.
All procedures performed at these visits are standard, non invasive clinical tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between 7 to 15 years old inclusive at time of enrolment.
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Assigned Intervention 1
Single vision contact lens
干预措施: Single-vision contact lens (Device)
Assigned Intervention 2
A.R.R.E.S.T.® contact lens
干预措施: A.R.R.E.S.T.® contact lens (Device)
结局指标
主要结局
Cycloplegic spherical equivalent autorefraction
时间窗: Baseline, then 6 months, and 12 months after baseline
Difference in change from Baseline in cycloplegic spherical equivalent autorefraction between each test and control.
Axial Length
时间窗: Baseline, then1 month, 3 months, 6 months, 9 months, and 12 months after baseline
Difference in change from baseline in axial length between each test and control.
次要结局
- Visual performance as measured by high contrast visual acuity at 6 m(Baseline, then 1 week, 1 month, 3 months, 6 months, 9 months, 12 months after baseline)
- Visual performance as measured by a non validated questionnaire based on a 1-10 numeric rating scale(1 month, 3 months, 6 months, 9 months, 12 months after baseline)