Effect of Combining Yoga to TENS on Diabetic Glaucoma

Cairo University (CU)

Status: Unknown

Conditions: Glaucoma; Diabetes Mellitus

Treatments: Device: sham TENS; Device: active TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT04645992

P.T.REC/012/002604

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

study group

Active Comparator group

Description:

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

Treatment:

Device: active TENS

control group

Sham Comparator group

Description:

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

Treatment:

Device: sham TENS