Wpływ Podawanego Doustnie Ekstraktu z Aronii, Jagody Kamczackiej Oraz Czarnej Jagody na Stan narządu Wzroku.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change in visual field (automated perimetry)
研究概览
简要总结
This study evaluated whether a standardized berry-extract dietary supplement (AKB; Aronia melanocarpa, Lonicera caerulea, Vaccinium myrtillus) improves visual function in adults with presbyopia. In a randomized, double-blind, placebo-controlled two-period crossover design, participants received AKB 400 mg twice daily and placebo for 6 weeks each, separated by a 5-week washout. Visual function and retinal/neuronal measures were assessed with contrast sensitivity testing, visual fields, VEP, and OCT/AngioOCT. Serum biomarkers related to lens and retinal physiology were also measured.
详细描述
Participants were randomized to one of two sequences (AKB→placebo or placebo→AKB). Each treatment period lasted 6 weeks, separated by a 5-week washout. Ophthalmological assessments were performed at baseline and during the final week of each treatment period. The primary analysis compared within-participant changes after AKB versus placebo.
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)
盲法说明
Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 50 years.
- •Clinical diagnosis of presbyopia.
- •Best-corrected visual acuity (BCVA) ≥ 20/
- •Spherical refraction between -3.0 and +3.0 diopters (D).
- •Cylinder correction ≤ ±3.0 D.
排除标准
- •Age < 50 years.
- •History of ocular surgery within 12 months prior to enrollment.
- •Presence of ocular diseases/conditions that may affect outcomes, including:
- •Macular degeneration
- •Diabetic retinopathy
- •Retinal vein occlusion
- •Other significant acquired or hereditary eye conditions
- •Neurological disorders affecting visual fields.
- •Refractive error outside eligibility limits:
- •Spherical refraction < -3.0 D or > +3.0 D
- •Cylinder correction > ±3.0 D
- •Systemic conditions that may influence optic nerve head perfusion, including:
- •Hypotension
- •Severe circulatory failure
- •Vascular endothelial disorders
- •Gastrointestinal conditions, including:
- •Hyperacidity
- •Peptic ulcer disease
研究组 & 干预措施
Intervention 1: Dietary Supplement: AKB
dose: 400 mg capsule, 1 capsule BID (2×/d) throug 6 weeks
干预措施: AKB (Dietary Supplement)
Intervention 2: Placebo
maltodextrin + natural caramel colouring, BID, 6 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Change in visual field (automated perimetry)
时间窗: Baseline and Week 6.
Change from baseline in visual field mean deviation (MD, dB) measured by standard automated perimetry measured by Humphrey Field Analyzer.
Change in PVEP P100 latency (pattern size 1.0)
时间窗: Baseline and Week 6.
Change from baseline to Week 6 in PVEP P100 latency (ms) measured by pattern-reversal VEP (pattern size 1.0).
Change in PVEP P100 amplitude (pattern size 1.0)
时间窗: Baseline and Week 6.
Change from baseline to Week 6 in PVEP P100 amplitude (µV) measured by pattern-reversal VEP (pattern size 1.0).
Change in PVEP P100 latency (pattern size 0.3)
时间窗: Baseline and Week 6.
Change from baseline to Week 6 in PVEP P100 latency (ms) measured by pattern-reversal VEP (pattern size 0.3).
Change in PVEP P100 amplitude (pattern size 0.3)
时间窗: Baseline and Week 6.
Change from baseline to Week 6 in PVEP P100 amplitude (µV) measured by pattern-reversal VEP (pattern size 0.3).
Change in OCT / OCT-angiography parameters
时间窗: Baseline and Week 6.
Change from baseline in RNFL thickness (µm) measured by spectral-domain OCT.
次要结局
- Change in serum CRYAA concentration(One month.)
- Change in serum CRYAB concentration(one month)
- Change in serum TRPV4 level(one month)
研究者
Dorota Szumny
Principal Investigator
Wroclaw Medical University