Effect of Fu's Subcutaneous Needling for Age-related Macular Degeneration
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 38
- 主要终点
- Best Corrected Visual Acuity
研究概览
简要总结
This pilot randomized controlled trial aims to evaluate the efficacy and safety of FSN in improving symptoms in patients with dAMD.38 eligible participants will be recruited and randomly assign them in a 1:1 ratio to the FSN group and the control group. Throughout the study, both groups will take oral vitamin C and vitamin E supplements for a total of 28 days. Participants in the FSN group will receive four treatment sessions over two weeks. Both groups will be assessed at the end of the FSN treating period during the mid-study period, with ocular blood flow dynamics measured using OCTA, followed by a two-week follow-up. The primary outcome of this trial is the change in visual acuity from baseline to week 2, with secondary outcomes including visual field, visual function scale, macular thickness, central avascular zone area vascular density, and choroidal thickness.
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
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •（ 1 ） Age between 50 and 85 years old with no gender restrictions （ 2 ） Meets the diagnostic criteria for dry age-related macular degeneration (AMD) as outlined in the 2023 Chinese Clinical Practice Guidelines for Age-Related Macular Degeneration （ 3 ） Both monocular and binocular cases of dry AMD are included. For patients with bilateral lesions the experimental group is based on the patient's preferred eye (if both eyes are preferred the average of the data collected from both eyes is included in the analysis) （ 4 ） Participants must voluntarily consent and sign an informed consent form and be willing to cooperate with follow-up visits.
排除标准
- •（ 1 ） Serious eye diseases that significantly affect the condition of the fundus excluding dry macular degeneration including fundus lesions such as fundus hemorrhage and wet macular degeneration; or concomitant eye diseases requiring immediate treatment such as acute glaucoma; severe opacity of the refractive media such as mature cataracts （ 2 ） In distance vision testing the patient cannot discern the direction of the largest character at a distance of 1 meter from the distance vision chart （ 3 ） Participants who have undergone eye surgery within the past six months （ 4 ） Participants with non-ophthalmic conditions that may severely affect vision such as large-area cerebral infarction cerebral hemorrhage diabetes thyroid eye disease vitamin A deficiency or Sjögren's syndrome （ 5 ） Pregnant or lactating women （ 6 ） Participants with severe anemia renal failure acute phase of cardiovascular disease implanted cardiac pacemaker thrombocytopenia or other hematological conditions with a high risk of severe subcutaneous bleeding or requiring skin puncture （ 7 ） Participants who have taken medications or consumed foods that affect ocular blood supply within the past week such as caffeine atropine or other treatments for macular degeneration （ 8 ） Participants who require contact lenses.
研究组 & 干预措施
Fu's subcutaneous needling group
Fu's subcutaneous needling group with oral Vitamin C and vitamin E supplements
干预措施: FSN+Vitamin supplement (Combination Product)
Control group
oral Vitamin C and vitamin E supplements
干预措施: Vitamin Supplements (Drug)
结局指标
主要结局
Best Corrected Visual Acuity
时间窗: Day 14
The best corrected visual acuity at distance and near will be tested as the main outcome after 2-week treatment，which is the mid period of intervention.During vision testing, paticipants stand 5 meters from the chart with one eye covered. The chart height is adjusted so the 1.0 line aligns with their eye level. For near vision assessment, the subject positions themselves 25 cm from the vision chart with one eye occluded.
次要结局
- Best Corrected Visual Acuity(FSN group:Baseline 2 days in FSN treatment period(days 4 and 11),follow-up day (day 28);Control group: Baseline follow-up day (day 28))
- Visual Function Questionnaire 25(both groups:baseline, end of FSN treatment week (day 14) follow-up day (day 28))
- OCTA metrics(baseline ,end of the FSN treatment week (day 14))
- Visual field(both groups:baseline, end of FSN treatment week (day 14) follow-up day (day 28))
研究者
Zhiming Yan
postgraduate of the Second Clinical College of Guangzhou University of Chinese Medicine
Guangdong Provincial Hospital of Traditional Chinese Medicine