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Clinical Trials/CTRI/2025/08/092590
CTRI/2025/08/092590Not yet recruitingPhase 2/3

Four Arm Randomized Controlled Trial to Evaluate the Comparative Neuroprotective Effect of Ayurveda Interventions as an Add on Therapy in Primary Open Angle Glaucoma

All India Institute of Ayurveda1 site in 1 country100 target enrollmentStarted: August 17, 2025Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Enrollment
100
Locations
1
Primary Endpoint
Comparative neuro-protective effect of Ayurveda interventions as an add on therapy in terms of Perimetry (MD-Mean Deviation, PSD-Pattern Standard Deviation, VFI-Visual Field Index), OCT Retinal Nerve Fiber Thickness to standard of care for 30 and 90 days to conventional standard care patients of primary open angle glaucoma.

Study Overview

Brief Summary

Glaucoma is the second leading cause of irreversible but preventable blindness globally, accounting for approximately 8% of global blindness and 12.8% of blindness in India. It ranks third after cataract and uncorrected refractive errors in India. Among its many types, Primary Open-Angle Glaucoma (POAG) is the most prevalent form, typically bilateral and adult onset, with a global prevalence of approximately 2.4%. POAG is characterized by elevated Intraocular Pressure (IOP), open anterior chamber angles, progressive optic nerve damage and characteristic visual field loss.

While reduction in IOP remains the primary and most established treatment and modifiable risk factor for preventing disease onset and progression, many patients continue to experience deterioration of visual function despite effective IOP control. This highlights the potential involvement of pressure independent mechanisms for progressive apoptosis of Retinal Ganglion Cell (RGC) in glaucomatous optic neuro degeneration.

Hence there is increasing interest in exploring neuroprotective strategies that go beyond IOP reduction, including neuroprotective agents and gene therapies that preserve RGDs. Ayurveda provides potential adjunctive option. Studies on Ayurvedic preparations such as Shigru Pallava Arka eye drops and Rasayana therapies have shown beneficial effect in preventing retinal damage. This study aims to assess comparative neuroprotective effect of Ayurveda interventions as an add-on therapy compared to standard care in management of Primary Open Angle Glaucoma (POAG).

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Baseline IOP less than or equal to 30mmHg.
  • Newly diagnosed and untreated patients of Primary Open Angle Glaucoma.
  • Diagnosis in either or both eye with Primary Open Angle Glaucoma.
  • Glaucomatous optic disc changes with peripapillary changes having Retinal Nerve Fiber layer defects and having vertical elaborate cup disc ratio 0.5 to 0.8.

Exclusion Criteria

  • Visual acuity less than 6/
  • Corneal abnormalities that could preclude accurate IOP readings with NCT or applanation tonometry.
  • Patients of POAG who have media opacities which is sufficient to interfere with detailed ONH evaluation,
  • Advanced DR and HTN retinopathy
  • All types of Angle Closure Glaucoma, secondary and developmental glaucoma and end stage (advanced) glaucomatous optic neuropathy.
  • Inability to use topical medications.
  • Active treatment for another ophthalmic condition in either eye.
  • Any previous ocular surgeries except for uncomplicated cataract extraction and YAG laser capsulotomy, laser glaucoma surgeries (Argon laser trabeculoplasty and/or selective laser trabeculoplasty).
  • Pregnancy or lactating women.
  • Involvement in any other interventional research study.

Outcomes

Primary Outcomes

Comparative neuro-protective effect of Ayurveda interventions as an add on therapy in terms of Perimetry (MD-Mean Deviation, PSD-Pattern Standard Deviation, VFI-Visual Field Index), OCT Retinal Nerve Fiber Thickness to standard of care for 30 and 90 days to conventional standard care patients of primary open angle glaucoma.

Time Frame: 0 day, 30 day, 90 day

Secondary Outcomes

  • Comparative effect of Ayurveda interventions as an add on therapy on intra ocular pressure by tonometry for 30, 60 and 90 days to conventional standard care patients of primary open angle glaucoma.(0 day, 30 day, 60 day, 90 day)

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Ramya

All India Institute of Ayurveda

Study Sites (1)

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