Effect of Combining Yoga to TENS on Diabetic Glaucoma

Not Applicable

• Conditions: Glaucoma; Diabetes Mellitus
• Interventions: Device: active TENS; Device: sham TENS

• Registration Number: NCT04645992
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2020-11
• Study Start: 2020-11-20
• Study First Submitted: 2020-11-21
• Study First Submitted QC: 2020-11-21
• Last Update Submitted: 2020-11-21
• Study First Posted: 2020-11-27
• Last Update Posted: 2020-11-27
• Primary Completion: 2021-02-01
• Study Completion: 2021-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	active TENS	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
control group	sham TENS	control group will be treated with the same protocol as the study group but with the unit of transcutaneous electrical nerve stimulation is off .

Primary Outcome Measures

Name	Time	Method
Intraoccular pressure measurement	immediately after the session	it will be measured in right and left eye

Secondary Outcome Measures

Name	Time	Method
Intraoccular pressure measurement	immediately after sixty minutes of session end	it will be measured in right and left eye

Trial Locations

Locations (1)

Faculty of Physical Therapy Cairo University; 🇪🇬 Giza, Dokki, Egypt