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临床试验/NCT03065907
NCT03065907已完成不适用

Timing of Low Vision Rehabilitation in Anti-VEGF Therapy: a Randomized, Controlled Trial

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2018年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3
试验地点
2
主要终点
Consent rate

研究概览

简要总结

The purpose of this research is to collect preliminary data in preparation for conducting a randomized clinical trial to determine the relative effectiveness of vision rehabilitation in improving overall visual ability (primary aim) and reducing depression (secondary aim) in patients receiving anti-VEGF therapy for neovascular age-related macular degeneration integrated over time.

详细描述

This is a pilot study to understand the feasibility of conducting a randomized, controlled trial regarding the timing for vision rehabilitation in patients receiving anti-VEGF therapy for neovascular age-related macular degeneration. Prior to initiating the clinical trial, the investigators must be assured that patients with loss in visual ability are willing to be randomized and amenable to deferring vision rehabilitation intervention. Although it is typical for patients receiving usual care to present for vision rehabilitation services years after the onset of anti-VEGF therapy, this manifestation may result from patients being unaware of the existence of vision rehabilitation services to enhance function and reduce depression. As part of the study recruitment, patients will be informed about vision rehabilitation care and, if suffering with difficulty performing everyday activities, they may be unwilling to defer vision rehabilitation. Additionally, the study design may not be feasible to answer the aim should patients in the delayed intervention arms suffer progressive loss in visual ability and seek vision rehabilitation services, resulting in a high drop-out rate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 105 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 50 years old
  • Primary diagnosis of neovascular age-related macular degeneration in the index eye or in both eyes if habitual visual acuity (HVA) is equivalent in both eyes
  • HVA < 20/25 to ≥ 20/500 in the index eye
  • Confirmed active anti-VEGF injections (a minimum of 2 injections in the past 3 months, a total of 8 injections maximum) in the index eye
  • Full confrontational visual fields in the index eye
  • Acknowledgement of having difficulty in visual ability function
  • Visual ability estimates as measured by ≥ 2 goals identified on the Activity Inventory as important and with at least slight difficulty
  • Telephone interview for cognitive status raw score is > 29
  • Ability to return to clinic to participate in rehabilitation
  • No prior experience with vision rehabilitation service

排除标准

  • Other progressive ocular conditions likely to compromise VA during the study period or upcoming eye surgeries
  • Anti-VEGF injections in the index eye 8 months prior to enrollment
  • Unable to give written consent to the study
  • Impaired hearing or cognitive ability that precludes telephone interviews
  • Insufficient spoken English or reading ability to complete interviews and understand study materials
  • The index eye is defined as the eye with better HVA, or the eye with more anti-VEGF injections if both eyes are with the equivalent HVA

结局指标

主要结局

Consent rate

时间窗: 2 months

Consent rate of the approached participants

次要结局

  • Breaking of randomization in group 2(18 months)
  • Retention rate(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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