Effect of Niacinamide Supplementation in Primary Open-angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- logMAR
研究概览
简要总结
Niacinamide is a chemical derivative of niacin, also known as vitamin B3. Through its complex role in the energetic metabolism, it has been evaluated and proven useful in several neurodegenerative disorders, such as Alzheimer's disease. Its effect in glaucoma, an optic nerve disorder related to a high intraocular pressure, is not well defined, and requires more research.
The investigators aim to assess the physiological effects of niacinamide on specific markers (e.g., visual field parameters, retinal nerve fibre layer thickness, electrophysiological markers such as the latency of the P2 wave on Flash visually evoked potentials) and on the quality of life in primary glaucoma patients.
详细描述
100 subjects with primary open-angle glaucoma will be enrolled from two centres (CMI profesor doctor Liliana Mary Voinea Bucharest Eye Centre and SC Optispecs Med SRL TgJiu Eye Clinic).
Participant Selection P1. Inclusion criteria
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Patients aged 18 years or older;
- Confirmed diagnosis of Primary Open angle Glaucoma (POAG) - following a complete ophthalmological examination (ocular tonometry, slit lamp ocular examination, visual field and Optical coherence tomography);
- Subject has provided signed and dated written informed consent before admission to the study.
- Subject is able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions.
- Participants need to have visual acuity of Snellen ≥ 6/12 (0.5) or better.
- Have performed at least two reliable VFs (SITA-Fast 24-2), with <33% fixation losses and <15% false positives
- Those taking NAM already will undergo a 1-month washout period before commencing the study.
P2. Exclusion criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older;
- •Confirmed diagnosis of Primary Open angle Glaucoma (POAG) - following a complete ophthalmological examination (ocular tonometry, slit lamp ocular examination, visual field and Optical coherence tomography); Subject has provided signed and dated written informed consent before admission to the study.
- •Subject is able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions.
- •Participants need to have visual acuity of Snellen ≥ 6/12 (0.5) or better.
- •Have performed at least two reliable VFs (SITA-Fast 24-2), with <33% fixation losses and <15% false positives
- •Those taking NAM already will undergo a 1-month washout period before commencing the study.
排除标准
- •Participants must not be pregnant or breastfeeding women;
- •Investigator considers the subject unfit for the study as a result of medical history, physical examination, or screening tests;
- •● VF damage worse than -10dB in the best eye and -16dB in the worse eye or a paracentral spot with -10dB or less in any eye),
- •OP >35mmHg in any eye or a mean IOP of 30mmHg or higher (two measurements), •inability to perform VFs,
- •those unwilling to abstain from NAM supplements,
- •allergic to NAM/niacin,
- •diagnosed with cancer in the last 5 years (except treated basal or squamous cell carcinoma),
- •a history of liver disease or stomach ulcers,
- •disease that prevents long-term follow-up, neurologic or other non-glaucomatous conditions apart from cataract that may affect the VF
- •Patient is diagnosed with primary angle closure glaucoma;
- •Patient is diagnosed with secondary glaucoma (e.g. posttraumatic, post inflammatory, steroid induced, pseudo exfoliative, pigmentary, etc.);
- •Patient is diagnosed with very advanced glaucoma (foveal fixation threatened or absent and, thus, unreliable perimetry);
- •Participants who are currently on NAM will be asked to stop taking the tablets for a month prior to screening visit.
- •Patient is diagnosed with other significant ocular pathologies (advanced cataract, pathologic myopia, corneal ectasias or dystrophies, sever amblyopia, vitreoretinal disease, active ocular inflammation, significant sequelae of ocular inflammation);
- •Unreliable ophthalmological investigations and non-compliance with examinations (e.g. high percentage of false negative and false positive errors when examining the visual field).
结局指标
主要结局
logMAR
时间窗: 3, 6 and 12 months from the baseline
Ophthalmological parameters ➔ Visual field parameters: logMAR
次要结局
- QoL(3, 6 and 12 months from the baseline)
研究者
Adina Turcu-Stiolica
Professor
University of Medicine and Pharmacy Craiova