| CTRI Number |
CTRI/2025/04/084340 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Clinical profile and quality of life visual disability patients |
|
Scientific Title of Study
|
Clinicoetiological profile and vision related quality of life in patients in visual disability |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NEHA K SETHI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Guru Gobind Singh Medical College and Hospital, Faridkot |
| Address |
Department of Ophthalmology,
GGS Medical College and Hospital
Faridkot
Faridkot
PUNJAB
151204
India |
| Phone |
7009909238 |
| Fax |
|
| Email |
neha.knew@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NEHA K SETHI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Guru Gobind Singh Medical College and Hospital, Faridkot |
| Address |
Department of Ophthalmology,
GGS Medical College and Hospital
Faridkot
Department of Ophthalmology,
GGS Medical College and Hospital
Faridkot
PUNJAB
151204
India |
| Phone |
7009909238 |
| Fax |
|
| Email |
neha.knew@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NEHA K SETHI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Guru Gobind Singh Medical College and Hospital, Faridkot |
| Address |
Department of Ophthalmology,
GGS Medical College and Hospital
Faridkot
PUNJAB
151204
India |
| Phone |
7009909238 |
| Fax |
|
| Email |
neha.knew@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab,India 151204 |
|
|
Primary Sponsor
|
| Name |
Dr Neha K Sethi |
| Address |
Department of Ophthalmology, Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab, India 151204 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neha K Sethi |
Ophthalmology department |
Dr Neha K Sethi
Room no 72, Ophthalmology OPD,
Guru Gobind Singh Medical College and Hospital, Faridkot
Faridkot
PUNJAB |
9888129095
neha.knew@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, GURU GOBIND SINGH MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. 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) |
|
| ExclusionCriteria |
| Details |
1. Patients with multiple disabilities
2. Patients who are unable to answer the NEI-VFQ questionnaire (unconscious, disoriented, unable to speak/understand local language ie Hindi / Punjabi or English) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Describe the clinic-etiological profile of visually disabled people of Punjab |
2 years approximately |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Describe association between vision related quality of life index and amount of visual disability |
2 years approximately |
|
|
Target Sample Size
|
Total Sample Size="385"
Sample Size from India="385"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
|
a) Study Setting: Department
of Ophthalmology 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
|
|