Spectacle Lenses Utilising P.A.U.S.E.® Technology for Slowing Down Myopia Progression in Vietnamese Children: A Prospective, Masked, Controlled, Randomised, Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 205
- 试验地点
- 2
- 主要终点
- Axial Length
研究概览
简要总结
The goal of this clinical trial is to learn if spectacle lenses using Phase Alteration Utilising Sub Elements (P.A.U.S.E.®) technology works to slow down the rate of myopia progression in myopic children. The first stage of the trial compares P.A.U.S.E.® spectacle lenses to single vision spectacle lenses in myopic children and the second stage looks at the rate of myopia progression in children while wearing P.A.U.S.E.® spectacle lenses. The main questions to answer are:
Do P.A.U.S.E.® spectacle lenses slow down the rate of axial length growth? Do P.A.U.S.E.® spectacle lenses slow down the rate of increase in myopic refractive error?
Researchers will compare P.A.U.S.E.® spectacle lenses to a single vision spectacle lens for 12 months followed by assessing P.A.U.S.E.® spectacle lenses for slowing down myopia progression for another 12 months.
Participants will be initially randomly allocated to wear either P.A.U.S.E.® spectacle lenses or single vision spectacle lenses and visit the clinic on five occasions over the first 12 months period.
After completing the first 12 months, all participants will wear P.A.U.S.E.® spectacle lenses and visit the clinic on three occasions over the second 12 months period.
详细描述
The aims of this clinical trial are:
- To compare the rate of myopia progression as measured by change from the Stage 1 Dispensing visit (up to 40 days from Baseline), in axial length and the change from Baseline in the cycloplegic spherical equivalent autorefraction between two spectacle lens designs using P.A.U.S.E.® technology (test-1 and test-2) and single vision spectacle lenses (control). Myopic children (6-14 years of age) will be randomly allocated to wear either test-1, test-2, or control.
- To assess the rate of myopia progression as measured by change from the Stage 2 Dispensing visit (up to 40 days from the Stage 1: 12-months visit), in axial length and the change from the Stage 1: 12-months visit in the cycloplegic spherical equivalent autorefraction while wearing P.A.U.S.E.® spectacle lenses. The myopic children from Stage 1 will enter Stage 2.
The overall trial duration, including follow-up period, is expected to be approximately 30 months. Each participant's duration is expected to be approximately 24 months.
The visits are:
Stage 1: Baseline, Dispensing, 1-, 6-, 12-months. Stage 2: Dispensing, 6- and 12- months
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
- Double (Participant, Care Provider)
盲法说明
Investigators, participants, and parents/legal guardians will be masked to the identity of the study product worn by each participant. All spectacle lenses will be fitted into the chosen spectacle frame. P.A.U.S.E.® optical elements may be visible under certain lighting conditions, and therefore, it may not be possible to completely mask test spectacle lenses from control spectacle lenses. However, complete masking is possible between test spectacle lenses. Regardless, investigators who perform crucial measurements (axial length and autorefraction) should not view a participant's study product to further minimise the chance of de masking
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between 6-14 years 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 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.
- •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 (Snellen: 20/25, 6/7.6; Decimal: 0.8) or better in each eye.
- •Meet the following criteria determined by cycloplegic autorefraction at Baseline:
- •o-5.00 D ≤ spherical equivalent ≤ -0.75 D and sphere component ≤ -0.50 DS. o-1.50 DC ≤ astigmatic component ≤ 0 DC. o|Spherical equivalent anisometropia| ≤ 1.00 D.
排除标准
- •Participant is currently an active participant in another study or was active 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.
- •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, Sjogren's 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.
研究组 & 干预措施
Assigned Intervention 3
P.A.U.S.E. spectacle lens 2
干预措施: P.A.U.S.E. spectacle lens 2 (Device)
Assigned Intervention 1
Single vision spectacle lens
干预措施: Single vision spectacle lens (Device)
Assigned Intervention 2
P.A.U.S.E. spectacle lens 1
干预措施: P.A.U.S.E. spectacle lens 1 (Device)
结局指标
主要结局
Axial Length
时间窗: Dispensing Visit (up to 26 days from Baseline), then 1 month, 6 months, and 12 months after Dispensing Visit
Difference in change from dispensing in axial length between each test and control.
Axial Length
时间窗: Stage 1: Dispensing Visit (up to 40 days from Baseline), then 1-, 6-, and 12-months after Stage 1: Dispensing Visit. Stage 2: Dispensing Visit (up to 40 days from Stage 1: 12 months), then 6- and 12-months after Stage 2: Dispensing Visit.
Difference in change from Stage 1 dispensing in axial length between each test and control. The change in axial length from the Stage 2 dispensing.
次要结局
- Cycloplegic spherical equivalent autorefraction(Baseline, then 6 months, and 12 months after Dispensing Visit (up to 26 days from Baseline).)
- Visual performance as measured by a non validated questionnaire based on a 1-10(1 month, 6 months, and 12 months after Dispensing Visit (up to 26 days from Baseline).)
- Visual performance as measured by high contrast visual acuity at 6 m(Dispensing Visit (up to 26 days from Baseline), then 1 month, 6 months, and 12 months after Dispensing Visit)
- Cycloplegic spherical equivalent autorefraction(Stage 1: Baseline, then 6- and 12-months after Stage 1: Dispensing Visit (up to 40 days from Baseline). Stage 2: Stage 1: 12 months visit, then 6- and 12-months after after Stage 2: Dispensing Visit (up to 40 days from Stage 1: 12 months visit).)
- Visual performance as measured by high contrast visual acuity at 6 m(Stage 1: Dispensing Visit (up to 40 days from Baseline), then 1-, 6-, and 12-months after Dispensing Visit Stage 2: Dispensing Visit (up to 40 days from Stage 2: 12 month), then 6- and 12-months after Dispensing Visit)
- Visual performance as measured by a non validated questionnaire based on a 1-10(Stage 1: 1-, 6-, and 12-months after Dispensing Visit (up to 40 days from Baseline). Stage 2: 6- and 12-months after Dispensing Visit (up to 40 days from Stage 1: 12-months).)
研究者
Daniel Tilia, MOptom, PhD
Principal Research Optometrist
nthalmic Pty Ltd