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临床试验/CTRI/2020/05/025441
CTRI/2020/05/025441尚未招募不适用

Quality of life in glaucoma patients: Comparison of medical therapy, trabeculectomy and glaucoma drainage device

Government Medical college and Hospital Chandigarh1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年5月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
HRQoL

研究概览

简要总结

Glaucomais one of the leading causes of preventable blindness, a close second tocataract, characterized by progressive optic neuropathy and correspondingvisual ï¬eld loss. Qualityof Life (QOL) as perceived by patients with focus on leading a healthy andindependent life is an important barometer of the success of any therapeuticmodality be it medical or surgical. This assessment guides clinician’streatment decision, and modifications to home environment facilitating theexecution of day to day house-hold activities. Tothe best of our knowledge, no study from India has compared the QOL in patientswith glaucoma on medical therapy and in post trabeculectomy and GDD placements. With this backgroundin mind we decided to conduct this hospital based cross sectional study  to measure and compare the QOL in patients with glaucomareceiving three types of treatment viz medical therapy, trabeculectomy and GDD placement using multipleinstruments which include vision-specific NEIVFQ25 and  GQL-15 questionairre enrolling 30 patients of each category.

研究设计

研究类型
Observational

入排标准

年龄范围
40.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • •Group I: Patients of moderate and severe glaucoma on medical therapy for a period of 3 months to 1 year.
  • •Group II: Patients who have undergone glaucoma filtration surgery in the form of trabeculectomy at least 3 months before the study.
  • •Group III: Patients who have undergone a glaucoma drainage device placement at least 3 months before the study.

排除标准

  • Patients with already compromised quality of life owing to physical disability, hearing disability or neuropsychiatric conditions.
  • Patients who had a trabeculectomy/implant surgery within the 3 months preceding the study period.
  • Patients with other eye diseases such as visually significant cataract, disorders affecting the retina like diabetic retinopathy, diabetic maculopathy, hypertensive retinopathy, age related macular degeneration (ARMD).
  • Patients who underwent a cataract surgery in combination with the trabeculectomy in the same sitting (phacotrabeculectomy).
  • Patients of mild glaucoma or those on monotherapy(receiving single drug therapy).

结局指标

主要结局

HRQoL

时间窗: 3 months-1 year

次要结局

未报告次要终点

研究者

发起方
Government Medical college and Hospital Chandigarh
申办方类型
Government medical college

研究点 (1)

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