NCT04645992

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

November 27, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

November 21, 2020

Last Update Submit

November 21, 2020

Conditions

Diabetes MellitusGlaucoma

Outcome Measures

Primary Outcomes (1)

  • Intraoccular pressure measurement

    it will be measured in right and left eye

    immediately after the session

Secondary Outcomes (2)

  • Intraoccular pressure measurement

    immediately after thirty minutes of session

  • Intraoccular pressure measurement

    immediately after sixty minutes of session end

Study Arms (2)

study group

ACTIVE COMPARATOR

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

control group

SHAM COMPARATOR

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

Interventions

active TENSDEVICE

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

study group
sham TENSDEVICE

control group will be treated with the same protocol as the study group but with the TENS unit is off .

control group

Eligibility Criteria

Age50 Years - 70 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with DM duration more than 5 years .
  • BMI will be \< 30 kg/m² .
  • patients with bilateral primary open-angle glaucoma.

You may not qualify if:

  • acute or chronic eye inflammation
  • cataract
  • eye surgeries
  • mental ill patients
  • patients who will refuse to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Cairo University

Giza, Dokki, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusGlaucoma

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOcular HypertensionEye Diseases

Study Officials

  • Ali Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Ismail, lecturer

CONTACT

02 01005154209allooka2012@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

November 21, 2020

First Posted

November 27, 2020

Study Start

November 20, 2020

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

November 27, 2020

Record last verified: 2020-11

Locations

EG(1)