¿Es Util la Acupuntura en la Degeneracion Macular? Prospective Study of Efficacy of Acupuncture in Macular Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 3
- 主要终点
- Change From Baseline in the Number of Letters Seen on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart
研究概览
简要总结
This is a single-arm study designed to assess the efficacy of acupuncture (Traditional Chinese Medicine) for chronic macular diseases of several types. All participants received acupuncture and massage and there is not a placebo group because it is not considered a good form to evaluate in Chinese Medicine due to, acupuncturing being a procedure is not as blind as is desired. As a control of the results in this trial, the outcomes could be contrasted against those reported in known medical publications and against expectations of the progress of the damage without treatment.
详细描述
Background.
WHO has included retinal diseases between conditions treatable by acupuncture and Traditional Chinese Medicine (TCM) has been used for retinal diseases in hospitals of China and in other parts of the world many years ago. Acupuncture and periocular massage act stimulating the vital energy to restore the normal function of the body.
Currently, most common treatments in Western Medicine, anti-VEGF, only are indicated for less than 10 percent of cases, which are the wet form or neovascular of AMD (NV-AMD) and they have restrictions for use, additionally, their cost and requirements are limiting for populations in all countries.
Objectives. The primary purpose of this study is to confirm the objective response among subjects with macular diseases treated with acupuncture and massage. The results of conventional treatment are published in similar trials and some of our patients have had intraocular injections previously.
It is important to feature the affordability of this therapy for low-income populations that do not have specialists or facilities nearby or for many governments that complain about the huge burden of the treatment of there diseases. In Colombia, the average cost of each intraocular injection by the time of this trial was about US 3.500 and it can be repeated every month, it requires a retina specialist and a surgical room, that is out of reach for many people in the country.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Masking is neither accurate nor reliable in a procedure such as acupuncture or massage.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Clinical diagnosis of Macular Disease.
- •The patient must accept treatment with acupuncture
排除标准
- 未提供
结局指标
主要结局
Change From Baseline in the Number of Letters Seen on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart
时间窗: Baseline and at end of study (up to 2 years)
The ETDRS scale of letters is commonly used to report outcomes in AMD, for this reason, this score was chosen to compare outcomes with similar studies. Accepted tables for conversion from Snellen to ETDRS were used. 85 letters are equivalent to 20/20 and 0 letters correspond to 20/200. It can be meaningful to analyze the results in this trial in the context of similar trials using anti-VEGF, or reporting a visual loss in those cases that are not treatable.
Change on Visual Acuity (VA) of the Treated Eyes From Baseline to the End of the Study
时间窗: Baseline, 2 months and every 2 months until month 24.
The primary objective is to assess if acupuncture treatment is linked to a change in visual acuity (VA). VA was obtained by an ophthalmologic assessment at baseline and every two months until month 24. VA measurements were taken with the patient in a sitting position using a Snellen chart at a testing distance of 6 meters. The scale in Snellen is given in fractional numbers corresponding 20/20 to a normal vision at 20 ft or 6 meters. According to the World Health Organization, the normal vision is to 20/25, severe impairment corresponds to VA worse than 20/200 or legal blindness. Each fraction corresponds to a determined line of the chart in which all letters are correctly identified and the variation or gain is appreciated by the lines gained or lost by each eye. Improvement means a fraction better than initial, stable is no change in VA and lost is the VA worst than those of baseline.
Eyes With Change From Baseline to the End of the Study in Distance Vision According to Categories CIE 10 Based on Lines Seen on the Snellen Chart.
时间窗: 24 months from baseline.
Change in Visual Acuity was Measured by the Numbers of Lines seen on the Snellen Chart from baseline to the end of the trial. The measure was obtained by an ophthalmologic assessment on both eyes at the beginning of the study and every two months until month 24 using the best correction. VA measurements (lines in which all letters are correctly identified) were performed with the patient in a sitting position using a Snellen chart at a testing distance of 6 meters and the variation is appreciated by the lines gained or lost by each eye. The measure in Snellen is given in fractional numbers. Each fraction corresponds to a determined line of the chart corresponding VA 20/20 or 6/6 to a normal vision at 20 ft or 6 meters. The range of normal vision according to the WHO is to 20/25 ft or 6/10m, Mild means VA worse than 6/12, Moderate means VA worse than 6/18, Severe means VA worse than 6/60 that is "legal blindness". Blindness is considered VA worse than 3/60.
Number of Eyes That Improved VA From Baseline to End of the Study in Participants With Different Forms of Macular Disease Treated With Acupuncture.
时间窗: 2 years
"Improved" was defined as cases that gained in visual acuity (Note: no minimum of letters was defined). "Stable" was defined as visual acuity did not change in the sense of not losing or gaining in the final identification of the optotypes. "Lost" was defined as patients who had a worse vision at the end than at the beginning (e.g., lost visual acuity because the disease continued its course and the treatment was not effective.)
次要结局
- Percentage of Participants Who Experienced Changes in Vision (Less Opacity, Less Distortion of Lines, Reduction of the Central Shadow)(Baseline and end of study (up to 2 years))
- Number of Participants With Adverse Events Both Treatment-related or Not Related to Treatment.(2 years)
研究者
Dra. Luz Helena Gutiérrez C
Luz Gutierrez Physician, MPH, Escuela Neijing, Research Coordinator.
Escuela Neijing
