Home OCT Guided Management Study of Subjects Diagnosed With Neovascular-AMD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Area under the fluid volume trajectory between treatments (nl-days) during the study period by fluid type (IRF/SRF/TRF)
研究概览
简要总结
During the last 25 years, OCT has become one of the most common imaging technologies used to diagnose and monitor retinal diseases, including AMD. The OCT self-imaging capabilities of the Notal Vision Home OCT (NVHO) system for retinal fluid visualization in the central 10 degrees were validated during several prospective clinical studies1,2,3,4,5. This study is designed to evaluate the retinal fluid exposure of eyes with NV-AMD, using the NVHO system to guide therapy.
详细描述
Study Design:
This single arm study will enroll up to 15 subjects diagnosed with NV-AMD in at least one eye. Subjects may have previously participated in Notal Home OCT studies. Both eyes of the subjects will be enrolled unless an eye does not meet the inclusion criteria of VA ≥ 20/320. Subjects will be consented and screened. During screening, clinic staff will provide an overview of the NVHO system to subjects. Subjects who meet all screening criteria will be enrolled.
Definitions of the 2 data sources by periods:
Prospective data collected during NVHO guided management period, termed the study period Retrospective data collection during the preceding reference period
Treatment During the Enrollment Visit:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to speak and understand English with fluency.
- •Ability to understand and agree to contents of informed consent either in writing or verbally.
- •At least 55 years of age on date of Screening Visit.
- •Diagnosed with NV-AMD in at least one eye and initiation of anti-VEGF treatment in that eye.
- •Visual Acuity of 20/320 or better.
- •Available and willing to conduct daily self-imaging at home for the duration of the trial.
排除标准
- •Any other retinal disease in the study eye requiring steroidal or anti-VEGF injections (anti-VEGF injections during the study period must be for NV-AMD).
- •Subject's schedule not conducive to completing daily tests at home with the Notal Home OCT device for the duration of the study. -
结局指标
主要结局
Area under the fluid volume trajectory between treatments (nl-days) during the study period by fluid type (IRF/SRF/TRF)
时间窗: 6 months
次要结局
- Percentage of days with MSI≥2 and with output eligible for fluid quantification(6 months)
- Dates of injections by type of drug during the study period(6 months)
- Time spent by physician and staff to communicate with the patients upon enrolment and during scheduling of NVHO related office visits(6 months)
- Percentage of days with successful imaging attempts during daily testing(6 months)
- Area under the fluid volume trajectory between treatments (nl-days) during the reference period by fluid type (IRF/SRF/TRF)(6 months)
- Characteristics of dry AMD (iAMD) eyes converted to NV-AMD and identified with the NVHO, including visual acuity and fluid volume.(6 months)
- Time spent by physicians and staff in review of NVHO report and updating the patient's electronic medical record(6 months)
- Maximal fluid volume reached averaged in a moving window of 3 consecutive testing days during the study period by fluid type (IRF/SRF/TRF)(6 months)
- Retina thickness in the central 1 mm circle (CST) and in the entire scan area(6 months)
- Visual acuity during office visits(6 months)