跳至主要内容
临床试验/NCT04645992
NCT04645992Unknown不适用

Effect Yoga in Addition to TENS on Diabetic Glaucoma

Cairo University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年11月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Intraoccular pressure measurement

研究概览

简要总结

Intraocular pressure (IOP) is maintained by a balance between aqueous production and outflow with an imbalance leading to elevated eye pressure. Very high levels of IOP will subject retinal cells to mechanical stress. In addition to mechanical injury, IOP elevation can impair ocular blood flow reducing perfusion pressure to retinal neurons. Long-term vascular and mechanical stresses can produce further injury at the optic nerve.

Elevated intraocular pressure (IOP) or ocular hypertension (OHT) is the only well-established modifiable risk factor for primary open-angle glaucoma (POAG), the most common form of glaucoma. Glaucoma is a class of optic neuropathy. It is main leading cause of blindness.

Glaucoma is classified on the basis of anatomic features as open angle (where the anterior chamber angle of the eye remains open) and angle-closure (with closure of the anterior chamber angle). Glaucoma is considered primary if the eye has no preexisting disease. Secondary forms of glaucoma are caused by various ocular or systemic diseases such as pigment dispersion syndrome and ocular trauma.

It seems reasonable to consider that a longer duration of diabetes mellitus (DM) with a prolonged insult to the retina and optic nerve via vascular, glial, and neuronal factors would be associated with a higher risk of OAG.

详细描述

patients with diabetic glaucoma (80 patients ) from both sexes will be divided to 2 groups, 40 patients for each group;

study group will receive only one session of 20 minutes yoga ocular training for 20 minutes followed by transcutaneous electrical nerve stimulation (TENS) by placing electrodes on skin over urinary bladder (BL) acupoints 61 and 62 for 20 minutes

control group will be treated with the same protocol as the study group but with the TENS unit is off.

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, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with DM duration more than 5 years .
  • •BMI will be < 30 kg/m² .
  • •patients with bilateral primary open-angle glaucoma.

排除标准

  • •acute or chronic eye inflammation
  • •eye surgeries
  • •mental ill patients
  • •patients who will refuse to participate in the study

研究组 & 干预措施

study group

Active Comparator

study group will receive only one session of yoga eye exercise for 20 minutes followed by transcutaneous electrical nerve stimulation by placing electrodes on skin over urinary bladder (BL) acupoints 61 and 62 for 20 minutes

干预措施: active TENS (Device)

control group

Sham Comparator

control group will be treated with the same protocol as the study group but with the unit of transcutaneous electrical nerve stimulation is off .

干预措施: sham TENS (Device)

结局指标

主要结局

Intraoccular pressure measurement

时间窗: immediately after the session

it will be measured in right and left eye

次要结局

  • Intraoccular pressure measurement(immediately after sixty minutes of session end)
  • Intraoccular pressure measurement(immediately after thirty minutes of session)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Mohamed Ali ismail

lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Cairo University

研究点 (1)

Loading locations...

相似试验