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临床试验/CTRI/2025/04/084340
CTRI/2025/04/084340尚未招募不适用

Clinicoetiological profile and vision related quality of life in patients in visual disability

Dr Neha K Sethi1 个研究点 分布在 1 个国家目标入组 385 人开始时间: 2025年4月21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
385
试验地点
1
主要终点
Describe the clinic-etiological profile of visually disabled people of Punjab

研究概览

简要总结

a)      Study Setting: Department
ofOphthalmology of GGS
Medical College, Faridkot

b)      Study Design: Descriptive cross-sectional study

c)      Study Population: Patients coming to Ophthalmology OPD/ IPD of GGS Medical college, Faridkot

d)      Sampling strategy: Consecutive sampling

e)      Sample size and justification: 385 [assuming confidence interval of 5 % and confidence level of 95%, population of visually disabled taken as 84 lakh based on 0.3% visual disability and 2.8 crore population (2012), using standard deviation from previous studies]

 Sample size = z-score2 * std dev * (1- std dev)

Margin of error 2

f)       Study tool: Diagnosis and cause of visual disability will be determined by detailed ophthalmological workup. The disability percentage will be assessed by using guidelines issued by MINISTRY OF SOCIAL JUSTICE AND EMPOWERMENT, Department of Empowerment of Persons with Disabilities (Divyangjan) in notification dated 4th January 2018. The NEI VFQ questionnaire, which is free to use, will be used.

g)      Statistical analysis: Data will be analyzed using latest statistical software. For continuous variables, the summary statistics of mean ± standard deviation (SD) will be used. For categorical data, number and percentages will be used. Chi-square (χ2) test or unpaired t test will used for analysis for normal data as appropriate. If non-normal data is there, appropriate tests will be used. The p-value of <0.05 will be taken statistically significant.

h)       Inter-department collaboration: With the department of community medicine for (i) patient counselling (ii) ‘quality of life’ data collection (iii) statistical analysis

i)    Methodology:

—  Enrollment of Subjects: After approval of study protocols, patients will be enrolled from the OPD, Department of Ophthalmology

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients with permanent visual disability [i.e. best corrected visual acuity (BCVA) of either eye 6/24 or less] on LogMAR chart according to national disability guidelines (Guidelines | Department of Empowerment of Persons with Disabilities | MSJE | Government of India [Internet].
  • [cited 2023 Jul 27].
  • Available from: https://disabilityaffairs.gov.in/content/page/guidelines.php).

排除标准

  • Patients with multiple disabilities
  • Patients who are unable to answer the NEI-VFQ questionnaire (unconscious, disoriented, unable to speak/understand local language ie Hindi / Punjabi or English).

结局指标

主要结局

Describe the clinic-etiological profile of visually disabled people of Punjab

时间窗: 2 years approximately

次要结局

  • Describe association between vision related quality of life index and amount of visual disability(2 years approximately)

研究者

发起方
Dr Neha K Sethi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

NEHA K SETHI

Guru Gobind Singh Medical College and Hospital, Faridkot

研究点 (1)

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