Cone Rescue in Retinitis Pigmentosa by the Treatment of Lycium Barbarum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- ETDRS Visual Acuity (High Contrast)
研究概览
简要总结
Objectives: To study the immediate effect and the persistent effect of Lycium barbarum (LB) treatment on retinal functions, especially the cone function, and retinal structure in patients with retinitis pigmentosa (RP) Design: Randomised controlled double-masked trial
Setting: Primary Care clinical trial
Participants: 120 RP subjects will be recruited from Ophthalmology department at The University of Hong Kong and the Retina Hong Kong. Interventions: Subjects will be randomly allocated to LB (treated with LB granules) or control (treated with placebo) groups for 1 year. After the 1st year, both groups will stop the treatment and all subjects will also have the same eye exam in 6-month period for the 2nd year.
Main outcome measures: The primary outcome is the total sensitivity scores of 30-2 & 60-4 programmes of Humphrey Visual Field Analysis (HVFA). The secondary outcomes are the b-wave amplitudes of Full-field Electroretinogram (ffERG) responses, the amplitudes of direct component and induced component of Multifocal Electroretinogram (mfERG), and the ETDRS visual acuity.
详细描述
The study was a randomized controlled trial with a double-masked, placebo-controlled design. All the subjects were randomly allocated into either LB (treatment) group or placebo (control) group.
All the eligible subjects had the eye examination, including VA using the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart, refractions, tonometry, external and internal ocular health assessments, and fundus photo-documentation. Three additional tests were conducted to investigate the functional and structural changes in the RP patients, including Ganzfeld Electroretinogram, Humphrey Visual Field Analyser (Zeiss, Dublin, USA) and Spectral-domain Optical Coherent Tomography (SD-OCT) (Heidelberg Engineering, USA).
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ocular conditions:
- •Retinitis pigmentosa;
- •best corrected VA LogMAR 0.20 or better;
- •Humphrey Visual Field Analysis (HVFA) 30-2 total mean defect > or = 250 Decibel;
- •Intra-ocular pressure (IOP) <21 mmHg;
- •van Herrick ratio < or = 0.5;
- •no other ocular diseases
- •Dietary conditions:
- •Fruit and vegetable intake <10 servings/day;
- •spinach or kale intake < or = serving/day;
- •dietary lutein intake < or = 5.4mg/day;
- •no intake of cod liver oil or omega-3 capsules;
- •dietary Lycium barbarum intake < or =10 fruits/week;
- •supplement intake < or = 5000 IU/day of Vit. A and < or = 30 IU/day of Vit. E;
- •alcoholic consumption < or = 3 beverages/day
排除标准
- •BMI > 40;
- •intake of any anticoagulants (especially Warfarin),
- •pregnant or planning to be pregnant;
- •other clinically significant systemic diseases, eg. diabetes, liver disease and heart disease
研究组 & 干预措施
Lycium Barbarum
Daily Lycium Barbarum dosage: 10g of granules for 12 months
干预措施: Lycium Barbarum (Dietary Supplement)
Placebo
Placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
ETDRS Visual Acuity (High Contrast)
时间窗: 12 months
The high contrast visual acuity will be measured at the time point of baseline and 12 months. Visual acuity is to measure the eye's ability to resolve fine detail with full refractive error correction. The change of acuity (sec of arc) between 12-month time point and baseline will be provided to show the effect of interventions. The changes of the treatment group will be compared with the changes of the placebo group to illustrate the treatment effect of Lycium Barbarum.
次要结局
- Implicit Times of Flash Electroretinogram(12 months)
- Amplitudes of Flash Electroretinogram(12 months)
- Visual Field Sensitivity(12 months)
研究者
Henry HL Chan, PhD
Associate Professor
The Hong Kong Polytechnic University