Effect of Combining Yoga to TENS on Diabetic Glaucoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect Yoga in Addition to TENS on Diabetic Glaucoma

Conditions
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Diabetes Mellitus, Glaucoma

Intervention / Treatment
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* Device: active TENS
* Device: sham TENS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with DM duration more than 5 years . BMI will be < 30 kg/m² . patients with bilateral primary open-angle glaucoma. Exclusion Criteria: acute or chronic eye inflammation cataract eye surgeries mental ill patients patients who will refuse to participate in the study

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: study group<br>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 | Device: active TENS<br>* study group will receive only one session of yoga eye exercise for 20 minutes followed by TENS by placing electrodes on skin over urinary bladder (BL) acupoints 61 and 62 for 20 minutes<br>|
| Sham Comparator: control group<br>control group will be treated with the same protocol as the study group but with the unit of transcutaneous electrical nerve stimulation is off . | Device: sham TENS<br>* control group will be treated with the same protocol as the study group but with the TENS unit is off .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoccular pressure measurement | it will be measured in right and left eye | immediately after the session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoccular pressure measurement | it will be measured in right and left eye | immediately after thirty minutes of session | 
| Intraoccular pressure measurement | it will be measured in right and left eye | immediately after sixty minutes of session end |