Rocklatan Trial With Optical Coherence Tomography Study of Retinal Perfusion
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Nerve Fiber Layer Plexus Capillary Density (NFLP CD)
研究概览
简要总结
The main purpose of this study is to learn more about how Rocklatan eye drops affects blood flow in the eye. The secondary purpose is to see if our study devices can detect changes in blood flow before and after instillation of Rocklatan.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The investigator will assign one eye to use the study drug, while the other eye (control) will remain on the clinically prescribed medication. The identity of the eye drop will be masked to both participants and study personnel who perform testing procedures or data analysis. The university research pharmacy will provide label masked bottles for each eye.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with both eyes with open angle glaucoma.
- •Abnormal VF (glaucomatous pattern with PSD abnormal at p<0.05 or GHT outside normal limits) on most recent two clinic visits on chart review
- •Glaucomatous disc abnormality on chart review and confirmed on baseline disc photograph
- •Overall average NFL thickness > 55 μm measured by Heidelberg Spectralis OCT -Glaucoma Module Premium Edition (chart review), consistent with early glaucoma
- •NFLP-CD deficit (below 5 percentile of normal) in any of the 8 sectors on the initial baseline visit
- •The difference in baseline NFLP-CD between the left and right eye should be less than 5% (% of area).
- •IOP >= 17 mm Hg on the most recent two clinic visits (chart review) after monotherapy with latanoprost in both eyes.
排除标准
- •Best corrected visual acuity worse than 20/30 on chart review of most recent clinic visit
- •Age < 21 years at baseline
- •Eye disease that could affect VF, NFL thickness, or NFLP (e.g., visually significant cataract, AMD, diabetic retinopathy, and optic neuropathy) at any study visit
- •OCT and OCTA scans not meeting quality criteria at baseline
- •Inability to cooperate with study procedures
- •Inability to commit to the study visits
研究组 & 干预措施
Eye with Diagnosed Glaucoma
干预措施: Rocklatan eye drops will be instilled nightly in one eye diagnosed with glaucoma for up to 12 months. (Drug)
Eye with Diagnosed Glaucoma
干预措施: Two optical coherence tomography (OCT) devices will be used to assess blood flow changes. (Device)
结局指标
主要结局
Nerve Fiber Layer Plexus Capillary Density (NFLP CD)
时间窗: From enrollment to end of treatment at 11-12 months
The primary outcome measure will be change in the overall peripapillary NFLP CD measured at 6 months and 11-12 month endpoint visits compared to baseline values.
次要结局
- Total Retinal Blood Flow (TRBF)(From enrollment to end of treatment at 11-12 months)
研究者
David Huang
Principal Investigator
Oregon Health and Science University