Short-term Efficacy and Safety of Transcleral Lutein Iontophoresis in Patients With Intermediate Amd and Reticular Pseudodrusen: a Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- functional parameter
研究概览
简要总结
There is limited data available on the efficacy and safety of Transscleral Lutein Iontophoresis (TSLI) in patients with in-termediate age-related macular degeneration (iAMD) and reticular pseudodrusen (RPD).
This retrospective multicentre study evaluated the functional and morphological outcomes of TSLI in patients with stage 2 and stage 3 iAMD with RPD. Autofluorescence (AF), Optical Coherence Tomography (OCT), Best Corrected Visual Acuity (BCVA), Intraocular Pressure (IOP), Macular Sensitivity (MS) and adverse events, were recorded at baseline, 1 month and 3 months follow-up after treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 55 and 80 years old
- •diagnosis of early to intermediate stage dAMD (based on AREDS criteria)
- •presence of RPD
- •Treated with scleral Lutein Iontophoresis
排除标准
- •GA or MNV in the included eye
- •any prior or any ongoing medical or surgical treatment of the included eye (including intravitreal injections, oral supplementation of lutein, zeaxanthin and or high dietary intake of antioxidants)
- •smokers (consummation of more than 20 cigarettes per day)
- •history of treatment with drugs with a well-known possible ophthalmic side-effect
- •known eye diseases such glaucoma, acute or chronic uveitis, advanced cataract, stage 4 dry eye disease or any opacities of the ocular media that do not permit high-quality imaging examinations
- •manifest refraction outside of -6 and +4 dioptres
- •BCVA < 40 EDTRS letters.
研究组 & 干预措施
transcleral lutein iontophoresis
结局指标
主要结局
functional parameter
时间窗: August 2023 to August 2024
best corrected visual acuity (logMar)
structural parameter over the course of follow-up
时间窗: August 2023 to August 2024
Outer retinal morphology using OCT and changes in FAF, specifically RPD type (1-4)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: August 2023 to August 2024
monitoring of adverse events over the course of the follow up (n)
次要结局
- functional parameter(August 2023 to August 2024)
研究者
Mario Damiano Toro
Professor
University of Naples