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Clinical Trials/CTRI/2025/04/084340
CTRI/2025/04/084340
Not yet recruiting
Not Applicable

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

Dr Neha K Sethi1 site in 1 country385 target enrollmentStarted: April 21, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Dr Neha K Sethi
Enrollment
385
Locations
1
Primary Endpoint
Describe the clinic-etiological profile of visually disabled people of Punjab

Overview

Brief Summary

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

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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).

Outcomes

Primary Outcomes

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

Time Frame: 2 years approximately

Secondary Outcomes

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

Investigators

Sponsor
Dr Neha K Sethi
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

NEHA K SETHI

Guru Gobind Singh Medical College and Hospital, Faridkot

Study Sites (1)

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