Four Arm Randomized Controlled Trial to Evaluate the Comparative Neuroprotective Effect of Ayurveda Interventions as an Add on Therapy in Primary Open Angle Glaucoma
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: 0 day, 30 day, 90 day
次要结局
- 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)
研究者
Ramya
All India Institute of Ayurveda