A Single-Center Proof Of Concept Study of a Novel Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configuration Devices
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Indicate Device N Provided a More Comfortable Experience, Compared With Device C
研究概览
简要总结
In this study, participants will be imaged using two Optical Coherence Tomography (OCT) devices: device N, a standard conventional OCT device with an invention (comfortable chin and forehead rest that can be adjusted to fit each individual's size) attached to the device; and device C, the standard conventional OCT device with no invention attached. The investigators will assess whether the chin and forehead rest attachment (invention) provides a more comfortable experience for patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers; OR,
- •AMD, diabetic retinopathy, central serous chorioretinopathy, and/or glaucoma or glaucoma suspects or any other suspected eye disease
- •Group-Specific Inclusion Criteria:
- •- There are no group-specific inclusion criteria for patients with AMD, diabetic retinopathy, and central serous chorioretinopathy.
- •Healthy Volunteers
- •A normal clinical ophthalmic examination.
- •Reliable VF, reproducible glaucoma hemifield tests labeled within normal limits on at least one test.
- •Good quality (adequate signal strength ≥ 6/10, without segmentation algorithm failure and motion artifacts > 1 vessel diameter) RNFL and Ganglion Cell Inner Plexiform Layer (GCIPL) OCT, within normal limits.
- •Primary Open Angle Glaucoma (POAG)
- •Clinical characteristics of glaucoma: optic nerve head (ONH) abnormalities: global rim thinning, rim notch, or disc hemorrhage; retinal nerve fiber layer (RNFL) defect.
- •Typical glaucomatous field loss in reliable VF, reproducible glaucoma hemifield tests labeled outside normal limits on at least two consecutive tests.
- •Good quality (adequate signal strength ≥ 6/10, without segmentation algorithm failure and motion artifacts > 1 vessel diameter) RNFL and GCIPL OCT, labeled outside normal limits with typical glaucomatous RNFL and GCIL thinning.
- •Normal Tension Glaucoma (NTG)
- •Identical to POAG criteria with IOP recorded at ≤ 21 mmHg at any time point.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Any medical treatment (e.g., chronic corticosteroid, hydroxychloroquine, chloroquine, thioridazine, canthaxanthine) or conditions that affect VF (e.g., stroke) and retinal thickness other than glaucoma.
结局指标
主要结局
Percentage of Participants Who Indicate Device N Provided a More Comfortable Experience, Compared With Device C
时间窗: Post-Imaging Session (Day 1)
Participants will be asked which device provided a more comfortable experience: Device C or Device N.
Comfort Level Rating of Device N on 0-5 Scale
时间窗: Post-Imaging Session (Day 1)
Participants will be asked to rate how comfortable Device N was, on a scale of 0-5. Higher scores indicate higher levels of comfort.
Comfort Level Rating of Device C on 0-5 Scale
时间窗: Post-Imaging Session (Day 1)
Participants will be asked to rate how comfortable Device C was, on a scale of 0-5. Higher scores indicate higher levels of comfort.
次要结局
- Time Duration to Adjust for Number of Motion Artifacts Present With Device N Imaging(Imaging Session (Day 1))
- Time Duration to Adjust for Number of Motion Artifacts Present With Device C Imaging(Imaging Session (Day 1))