Cluster-randomised trial of community-based screening for eye disease in adults in Nepal: the Village-Integrated Eye Worker Trial II (VIEW II) trial protocol.

Cluster-randomised trial of community-based screening for eye disease in adults in Nepal: the Village-Integrated Eye Worker Trial II (VIEW II) trial protocol.
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尼泊尔成人眼病社区筛查的随机对照试验:乡村综合眼科工作者试验II(VIEW II)试验方案

DOI:
10.1136/bmjopen-2020-040219
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发表时间:
2020-10-15
期刊:
影响因子:
2.9
通讯作者:
Group Information for the VIEW II Study Group
Group Information for the VIEW II Study Group
中科院分区:
医学3区
文献类型:
--
作者:
O'Brien KS;Stevens VM;Byanju R;Kandel RP;Bhandari G;Bhandari S;Melo JS;Porco TC;Lietman TM;Keenan JD;Group Information for the VIEW II Study Group

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全世界大多数失明都可以通过早期诊断和治疗来预防或逆转,但识别高危和流行的眼病病例并将其与护理联系起来仍然是解决这一负担的重要障碍。青光眼、糖尿病性视网膜病变和老年性黄斑变性等主要致盲原因在早期可检测到无症状阶段,并可导致不可逆的视力丧失。对这些疾病进行大规模筛查可以减少人口一级的视力损害。该方案描述了一项平行组群集随机试验,旨在确定是否以社区为基础的青光眼,糖尿病视网膜病变和年龄相关性黄斑变性筛查减少尼泊尔人口水平的视力损害。在所有研究社区进行挨家挨户的人口普查。所有年龄≥60岁的成年人在普查访视时进行视力检查,符合转诊标准的人被转诊到当地眼科护理机构进行进一步诊断和管理。社区随后被随机分配到一个基于社区的筛查方案或没有额外的干预。干预包括对所有≥60岁的成人进行单轮筛查,包括眼内压和光学相干断层扫描评估,并加强与符合转诊标准的参与者的护理联系。干预实施4年后,盲态结局评估员进行重复普查,以收集主要结局(视力)的数据。有视力障碍的个人接受全面的眼科检查,以确定视力障碍的原因。根据最初分配的干预,按治疗组比较结局。该试验已获得加州大学旧金山弗朗西斯科机构审查委员会、尼泊尔Netra Jyoti Sangh和尼泊尔健康研究理事会的伦理批准。这项试验的结果将通过在同行评审的期刊上发表和在当地和国际会议上发表来传播。 NCT03752840
The majority of blindness worldwide could be prevented or reversed with early diagnosis and treatment, yet identifying at-risk and prevalent cases of eye disease and linking them with care remain important obstacles to addressing this burden. Leading causes of blindness like glaucoma, diabetic retinopathy and age-related macular degeneration have detectable early asymptomatic phases and can cause irreversible vision loss. Mass screening for such diseases could reduce visual impairment at the population level. This protocol describes a parallel-group cluster-randomised trial designed to determine whether community-based screening for glaucoma, diabetic retinopathy and age-related macular degeneration reduces population-level visual impairment in Nepal. A door-to-door population census is conducted in all study communities. All adults aged ≥60 years have visual acuity tested at the census visit, and those meeting referral criteria are referred to a local eye care facility for further diagnosis and management. Communities are subsequently randomised to a community-based screening programme or to no additional intervention. The intervention consists of a single round of screening including intraocular pressure and optical coherence tomography assessment of all adults ≥60 years old with enhanced linkage to care for participants meeting referral criteria. Four years after implementation of the intervention, masked outcome assessors conduct a repeat census to collect data on the primary outcome, visual acuity. Individuals with incident visual impairment receive a comprehensive ophthalmological examination to determine the cause of visual impairment. Outcomes are compared by treatment arm according to the originally assigned intervention. The trial has received ethical approval from the University of California San Francisco Institutional Review Board, Nepal Netra Jyoti Sangh and the Nepal Health Research Council. Results of this trial will be disseminated through publication in peer-reviewed journals and presentation at local and international meetings. NCT03752840
DOI: 10.1167/iovs.14-13980
发表时间: 2014-05-01
影响因子: 4.4
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DOI: 10.1016/s0002-9343(97)00089-2
发表时间: 1997-04-01
影响因子: 5.9
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DOI: 10.1136/bjophthalmol-2017-310716
发表时间: 2018-03-01
影响因子: 4.1
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DOI: 10.1016/j.ophtha.2011.10.021
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期刊: OPHTHALMOLOGY
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DOI: 10.2147/opth.s157560
发表时间: 2018
期刊: Clinical ophthalmology (Auckland, N.Z.)
影响因子: --
作者:
Thapa R;Twyana SN;Paudyal G;Khanal S;van Nispen R;Tan S;Thapa SS;van Rens G
通讯作者: van Rens G