| CTRI Number |
CTRI/2025/02/081299 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Barriers to treatment of cataract in rural patients |
|
Scientific Title of Study
|
Prevalence of cataract its risk factors and barriers of cataract surgery among older population in tertiary care centre of vidarbh region |
| 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 Janmejay Shaileshkumar Patel |
| Designation |
Postgraduate student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Ophthalmology, Ground floor AVBRH Building, Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9662687934 |
| Fax |
|
| Email |
janmejay4867@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravin Tidake |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Ophthalmology, Ground floor AVBRH Building, Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
7887476011 |
| Fax |
|
| Email |
drpravinktidake75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pravin Tidake |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Ophthalmology, Ground floor AVBRH Building, Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
7887476011 |
| Fax |
|
| Email |
drpravinktidake75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research Wardha India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha India 442001 |
| Type of Sponsor |
Private 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 Janmejay Shaileshkumar Patel |
Datta Meghe Institute of Higher Education and Research |
Department Of Ophthalmology , Ground Floor , AVBRH Building, Sawangi, Meghe , Wardha , India 442001
Wardha
MAHARASHTRA |
9662687934
janmejay4867@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Patients coming from Vidarbh region.
Aged 50 or above
Having Unilateral or Bilateral Cataract
Male / Female
Patients who gave consent
|
|
| ExclusionCriteria |
| Details |
patients below 50 years of age.
Not residents of vidarbh region .
Debilitated or terminally ill, who were currently suffering from any acute eye infections.
Those who have pseudophakia, aphakia, evisceration or enucleation in both eyes.
Patients who didn’t give consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall prevalence of cataract in the present study will be assessed. Association of risk factors like advancing age, systemic comorbidities, tobacco and alcohol usage, previous eye injuries, sunlight exposure with the prevalence of cataract will be assessed |
Assessment will be done at the end of 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
14/03/2025 |
| 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 Yet Recruiting |
| 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
|
Introduction: Cataract is the main cause of visual
impairment and preventable blindness in population aged 50 and more than 50
years. Increase in age, diabetes, hypertension, obesity, alcohol use, tobacco
use and exposure to sunlight are main risk factors for cataract development.
The prevalence of cataract is higher in low-income locality compared to
high-income locality and also higher among Older Population. So this study will
be conducted among a population, aged 50 and older.
Aim :The Aim of this study is to find the prevalence
of cataract, it’s risk factors and barriers of cataract surgery among older
population in tertiary care centre of vidarbh region.
Methodology :Approved by the local ethics committee, this study
will enroll patients coming from vidarbh
region aged 50 or above at AVBRH sawangi , Wardha. Using descriptive cross
sectional study patients will be interviewed using semi structured performa and
examined accordingly .
By simple randomized sampling patients
were examined for presence of unilateral or bilateral cataract and asked for
what are the risk factors associated with cataract development and what
barriers they face for till now not going for treatment , The data collection for this descriptive
cross-sectional study will be done over a period of 2 years |