A Study to Analyse the Effect of 365 Breathing Technique as an Adjunctive Modality along with Standard Medical Management on Intraocular pressure, Serum Cortisol and Optic nerve Head perfusion in Patients with Primary Open Angle Glaucoma.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Intraocular Pressure in two groups of patients(A and B).
研究概览
简要总结
Glaucoma is one of the leading causes of irreversible blindness in the world. IOP remains the only modifiable risk factor. Many other mechanisms are known to contribute to glaucomatous nerve damage.
Many studies have shown a positive correlation between physiological stress and glaucoma. A growing number of studies have shown that breathing techniques are effective in reducing stress by influencing both psychological factors by diverting attention from negative thoughts and physiological factors by stimulating parasympathetic nervous system.
AIM of our trial is to study the effect of “365 breathing technique†as an adjunct to standard medical management on Intraocular pressure, Optic nerve head perfusion and Serum cortisol in patients with Primary Open Angle Glaucoma: a Randomized study.
In this randomized controlled trial,35 patients fulfilling inclusion criteria will be kept as Group A and will be kept only on pharmacological antiglaucoma treatment and will be waitlisted for same intervention and 35 patients will be included in Group B who will be performing 365 breathing technique along with their pharmacological antiglaucoma treatment.
Planned sample size-70 (Group A -35 and Group B- 35).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Early to moderate Primary open angle glaucoma (as per Hodapp Parish Anderson classification) : newly diagnosed & started on medication that is Treatment naïve POAG patients and POAG patients previously on topical antiglaucoma medications.
- •2.Age: 40-80 years 3.Willing to consent with regular follow up and perform 365 breathing.
- •4.Geographical proximity : Preferably District Jaipur (rural & urban ).
排除标准
- •Ocular morbidities other than glaucoma contributing to visual loss ( ocular trauma, angle closure glaucoma , Retinal diseases ).
- •Any ocular surgery in previous three months.
- •Deaf/ Communication impaired/Subnormal mentation.
- •Already practicing Yoga/Meditation in any form since long time.
- •Chronic systemic diseases significantly affecting quality of life like Malignancy, Respiratory disease, Thyroid disease ,coronary artery disease, Hypertension , Diabetes mellitus, rheumatoid arthritis & autoimmune diseases& chronic allergies .
- •On any long term drugs known to affect autonomic functions like anticholinergics including antidepressants, Antihistamines, Diuretics, sympathomimetic and parasympathomimetic agents.
- •Geographically very far ( outside Jaipur ) and unable to come for regular follow up.
结局指标
主要结局
Change in Intraocular Pressure in two groups of patients(A and B).
时间窗: At 6 weeks and 16 weeks after enrolment.
次要结局
- Changes in Optic nerve head perfusion and Serum Cortisol in two groups of patients (A and B).(At 16 weeks after enrolment.)
研究者
Dr Sonal Kalia
SMS Medical College JAIPUR