Clinical trial NCT04645992: Effect of Combining Yoga to TENS on Diabetic Glaucoma
Official title: Effect Yoga in Addition to TENS on Diabetic Glaucoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Glaucoma
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-11-27
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intraoccular pressure measurement
timeFrame: immediately after the session
Secondary outcomes:
measure: Intraoccular pressure measurement
timeFrame: immediately after thirty minutes of session
measure: Intraoccular pressure measurement
timeFrame: immediately after sixty minutes of session end
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy Cairo University
state: Dokki
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References: