Anti-cataract Effects Of Cineraria maritima Eye Drops In The Progression Of Immature Cataract: A Pilot Open-label Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 1. Change in symptoms & signs– blurring of vision,visualization of non-existing things, nyctalopia, hemeralopia, glare, intra-ocular pressure, unaided distant visual acuity, pin hole vision, best corrected distant visual acuity using grading pattern by Snellen’s chart and Jaeger’s chart reading
研究概览
简要总结
A study titled "**ANTI-CATARACT EFFECTS OF CINERARIA MARITIMA EYE DROPS IN THE PROGRESSION OF IMMATURE CATARACT: A PILOT OPEN-LABEL PROSPECTIVE OBSERVATIONAL STUDY"**is a Pilot Open-Label Prospective Observational Study of 2 years and 6 months duration with a Primary Objective to evaluate the effects of Cineraria maritima eye drops on the signs & symptoms of cataract, in the improvement of visual acuity using Snellen’s chart and Jaeger’s chart reading and to evaluate the change in grading of cataract using Slit lamp Biomicroscopic examination. Secondary Objective is to evaluate the anti-cataract effects of Cineraria maritima eye drops on visual scores & quality of life based on VFQ-25. Patients between 40 to 80 years of age, both gender, visual acuity better than or equal to 6/60 Snellen chart, and patients who meet the diagnostic standards of immature cataract using slit lamp Biomicroscopic examination will be included in study. Patients suffering from congenital Cataract, mature and hypermature Cataract, Glaucoma, Diabetic Retinopathy, Hypertensive retinopathy, Macular degeneration, Retinitis pigmentosa, Patients with uncontrolled blood sugar and blood pressure, Patients who are under steroid treatment or Immunosuppressive therapy or any Cataract inducing medications, patients unwilling to participate in the study will be excluded from the study. Primary outcome will be change in symptoms & signs– blurring of vision, visualization of non-existing things, nyctalopia, hemeralopia, glare, intra-ocular pressure, unaided distant visual acuity, pin hole vision, best corrected distant visual acuity using grading pattern on quarterly basis by Snellen’s chart and Jaeger’s chart reading at baseline and at every quarterly follow up & change in Grading of cataractous lens,, according to lenticular opacity classification system III to assess changes in the area and density of lenticular opacity by Slit lamp Biomicroscopic examination, in tangentional sectioning and retro illumination technique at baseline, 6th month, 12th month and at the end of treatment (18th month) & Secondary outcomewill be Change in visual score & quality of life to be assessed by VFQ-25 at baseline and at every quarterly follow up and at the end of treatment (18th month).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)(—)
入选标准
- •Patients between 40 to 80 years of age Gender: both Visual acuity better than or equal to 6/60 Snellen’s chart Patients who meet the diagnostic standards of immature cataract using slit lamp Biomicroscopic examination.
排除标准
- •Patients suffering from congenital Cataract, mature and hypermature Cataract, Glaucoma, Diabetic Retinopathy, Hypertensive retinopathy, Macular degeneration, Retinitis pigmentosa Patients with uncontrolled blood sugar and blood pressure Patients who are under steroid treatment or Immunosuppressive therapy or any cataract-inducing medications Unwilling to participate in the study.
结局指标
主要结局
1. Change in symptoms & signs– blurring of vision,visualization of non-existing things, nyctalopia, hemeralopia, glare, intra-ocular pressure, unaided distant visual acuity, pin hole vision, best corrected distant visual acuity using grading pattern by Snellen’s chart and Jaeger’s chart reading
时间窗: 1. Baseline, end of 3rd month, 6th month, 9th month, 12th month, 15th month & 18th month | 2. Baseline, end of 6th month, 12th month & 18th month
2. Change in grading of cataractous lens, according to lenticular opacity classification system III to assess changes in the area and density of lenticular opacity by slit lamp biomicroscopic examination, in tangentional sectioning and retro illumination technique
时间窗: 1. Baseline, end of 3rd month, 6th month, 9th month, 12th month, 15th month & 18th month | 2. Baseline, end of 6th month, 12th month & 18th month
次要结局
- Change in visual score & quality of life to be assessed by VFQ-25(baseline, end of 3rd month, 6th month, 9th month, 12th month, 15th month & 18th month)
研究者
Dr Renu Mittal
Central Council for Research in Homoeopathy
