Effect of Combining Yoga to TENS on Diabetic Glaucoma

Effect Yoga in Addition to TENS on Diabetic Glaucoma

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.

Study Overview

• Status: Unknown
• Conditions: Glaucoma; Diabetes Mellitus
• Intervention / Treatment: Device: active TENS; Device: sham TENS

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dokki
    • Giza, Dokki, Egypt
      • Recruiting
      • Faculty of Physical Therapy Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: study group; 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; 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
SHAM_COMPARATOR: control group; 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; control group will be treated with the same protocol as the study group but with the TENS unit is off .

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2020
• Primary Completion (ANTICIPATED): February 1, 2021
• Study Completion (ANTICIPATED): February 1, 2021

Study Registration Dates

• First Submitted: November 21, 2020
• First Submitted That Met QC Criteria: November 21, 2020
• First Posted (ACTUAL): November 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 27, 2020
• Last Update Submitted That Met QC Criteria: November 21, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: P.T.REC/012/002604

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No