TO EVALUATE EFFECTIVENESS OF TRANSCRANIAL DIRECT CURRENT STIMULATION (tDCS) FOR IMPROVING COGNITIVE FUNCTION IN PRIMARY OPEN ANGLE GLAUCOMA (POAG)
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- To evaluate the change in cognitive functioning after tDCS in individuals with Primary Open Angle Glaucoma (POAG)
Study Overview
Brief Summary
• Individuals with Primary open angle glaucoma (POAG) may experience a heterogeneous set of visual and cognitive impairment, progressively deteriorating their quality of life
• Addressing cognitive deficits could improve outcomes in POAG.
• Transcranial direct current stimulation (tDCS) has shown promise in improving cognitive dysfunction in Neurocognitive disorders (NCDs). Since POAG has similar cognitive dysfunction as NCDs, tDCS may be a valuable tool to manage such cognitive dysfunction in these individuals.
. Patient Assessments
(a) General Physical Examination:
(b) Systemic examination:
(c) Ocular examination:
- Best Corrected Visual acuity using ETDRS and Snellen’s chart
- Baseline IOP using NCT
- Stereoscopic fundus evaluation
- Ophthalmic Investigations:
- HVF 30-2 SITA Standard for Visual Field Analysis
- Retinal nerve fiber layer Optical Coherence Tomography (RNFL OCT)
- Ganglion cell complex Optical Coherence Tomography (GCC OCT)
- Disc photographs
(d) Cognitive evaluation tests
- Addenbrooke Cognitive examination – for Comprehensive Cognitive evaluation
- Functional Near Infrared Spectroscopy (fNIRS) - Oxygenated Hemoglobin (OxyHb) concentration change
Total time for administration of cognitive tests = 30 minutes/patient
(e) Pharmacological test
- Serum cortisol levels – 9 AM to 10 AM
(f) Quality of life assessment using EuroQol (EQ-5D-5L)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of POAG Age more than 40 years BCVA more than 6 by 12 in both eyes Literate, educated up to 5th standard Willing to participate in study.
Exclusion Criteria
- •Patients with other forms of glaucoma Age less than 40 years BCVA less than 6 by 12 in either eye Eye disease other than glaucoma that could have affected RNFL and GC-IPL thickness, such as macular degeneration and optic neuropathy Patients on systemic medications which could affect cognition example BZPs, Opiates, TCAs, Anticonvulsants and Dopamine agonists.
- •Patients with diagnosed neurological or psychiatric disease.
- •Patients with chronic systemic disease such as Diabetes, Coronary Artery Disease or Cerebrovascular Disease.
Outcomes
Primary Outcomes
To evaluate the change in cognitive functioning after tDCS in individuals with Primary Open Angle Glaucoma (POAG)
Time Frame: At baseline and follow up at 1 month and 3 month
Secondary Outcomes
- • To evaluate the association of cognitive functioning in POAG with Quality of life using EuroQol (EQ-5D-5L)(• To evaluate the association of cognitive functioning in POAG with)
Investigators
TANUJ DADA
DR R.P CENTRE OF OPHTHALMIC SCIENCES NEW DELHI