| CTRI Number |
CTRI/2024/05/067218 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
12/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Use of digital devices and its association with eye disorders in adult population of a rural area in Delhi |
|
Scientific Title of Study
|
Use of digital devices and its association with ocular morbidity in adult population of a rural area in Delhi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajat Rupam |
| Designation |
Postgraduate student |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Department of Community Medicine, 3rd floor pathology Block, Maulana Azad Medical College, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
7538928736 |
| Fax |
|
| Email |
rajatrupam1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bratati Banerjee |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Department of Community Medicine, 3rd floor pathology Block, Maulana Azad Medical College, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968604251 |
| Fax |
|
| Email |
bratati1@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajat Rupam |
| Designation |
Postgraduate student |
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
Department of Community Medicine, 3rd floor pathology Block, Maulana Azad Medical College, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
7538928736 |
| Fax |
|
| Email |
rajatrupam1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Community Medicine, Maulana Azad Medical College, New Delhi, Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College Campus,
2, Bahadur Shah Zafar Marg, near Delhi Gate,
Balmiki Basti, New Delhi, Delhi, 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Rajat Rupam |
Rural Health Training Centre, Barwala |
Health Centre, Barwala, Sector-35, Rohini, Delhi- 110039
North West
DELHI |
7538928736
rajatrupam1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospital Institutional Ethics Committee |
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 |
59.00 Year(s) |
| Gender |
Both |
| Details |
Any adult individual of the age group 18-59 years residing in the study area for at least 6 months, who has access to any digital device. |
|
| ExclusionCriteria |
| Details |
1. Participants with visual acuity less than 3/60 or inability to count fingers at 3 metres.
2. Participants who are unable to communicate.
3. Participants with severe acute illnesses.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
i. Proportion of study participants with excessive use of digital devices.
ii. Prevalence of ocular morbidities under consideration.
iii. Association between use of digital device and ocular morbidities.
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i. Mean time and pattern of use of digital devices.
ii. Association of sociodemographic and behavioural factors with use of digital device and ocular morbidities.
|
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="263"
Sample Size from India="263"
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)
|
24/05/2024 |
| 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="1"
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
|
The aim of the thesis is to study the association between use of digital devices and common
ocular morbidities in adult individuals residing
in a rural area of Delhi. There is a paucity of studies related
to use of digital devices and
its association with ocular morbidities in adult population of a rural area in
India. The study will be
conducted at Barwala village in the rural field practice area under Department
of Community Medicine, Maulana Azad Medical College, New Delhi. The study population is adult population of 18-59 years of age with access to a digital device, residing in the area for at least 6 months where the study will be conducted. |