Daily Testing at Home by NV-AMD Subjects With Notal Home OCT.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Percentage of successful imaging attempts during daily testing.
研究概览
简要总结
The purpose of this study is to evaluate the ability of subjects with NV-AMD to perform sequential daily self-imaging of their eyes with the self-operated Notal Home OCT device in their homes for 90 days without on-site supervision. The study will include up to 15 subjects.
详细描述
Office Visit screening visit:
- The patient will be informed concerning the study and sign the Informed Consent Form (ICF) prior to conduct of any study procedures
- The following data will be collected for each study subject:
a .Subject's DOB (if allowed) or age b. Gender c .Race d. Ethnicity 3. BCVA on both eyes on the day of the visit 4. Both eyes of the subject will be scanned, non-dilated, with either a commercial Zeiss Cirrus or Heidelberg Engineering Spectralis OCT device with one (1) acceptable volume scan of each eye being obtained 5. Both eyes of the subject that meet all screening criteria will be enrolled 6. The following data will be collected for the study eye(s):
- Qualifying diagnosis for the study eye from the subject's medical record
- From the subject's medical record, the presence of other ophthalmic conditions including but not limited to:
i. Cataract ii. Glaucoma iii. Dry Eye iv. Other macula findings 7. The subject will receive a general overview of the self-operation of the Notal Home OCT at the investigational clinic facility by trained study personnel. A Notal Home OCT device is then assigned to the subject. 8. The subject will be reminded that the Notal Home OCT will be delivered to their home and instructed to self-image the study eye(s) daily using a Notal Home OCT device at home for 90 days.
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.
- •At least one enrolled eye per subject had retinal fluid treated with anti-VEGF in the prior 6 months, with a treatment interval of 8 weeks or less.
- •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
Percentage of successful imaging attempts during daily testing.
时间窗: 90 days
次要结局
- Percentage of volume scans with Manufacturer Image quality Index (MSI) >=2 (in a scale of 0-7, where 2 is a pre-defined acceptable-MSI cutoff)(90 days)
- Percentage of eyes successfully completed the set up and calibration(10-15 minutes)
- Percentage of eligible B-scans out of the maximum 88 in each volume scan during daily testing(90 days)