| CTRI Number |
CTRI/2024/11/076788 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The Impact Of Cataract Surgery On Vision For Various Jobs And Daily Life In The Community |
|
Scientific Title of Study
|
Occupation-Specific Visual Outcomes And Quality Of Life Post Cataract Surgery In a Community Setting |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shruti Dagar |
| Designation |
Assistant Professor, Optometrist |
| Affiliation |
Sankara Eye Hospital |
| Address |
Room no 10, department of refraction, sankara eye hospital,Ludhiana 141101
Room no 10, department of refraction, sankara eye hospital, Ludhiana 141101
Ludhiana
PUNJAB
141101
India |
| Phone |
8585925728 |
| Fax |
|
| Email |
shruti.dagar09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shruti Dagar |
| Designation |
Assistant Professor, Optometrist |
| Affiliation |
Sankara Eye Hospital |
| Address |
Room no 10, department of refraction, Sankara eye hospital hospital, Ludhiana 141101
Room no 10, department of refraction, Sankara eye hospital hospital, Ludhiana 141101
Ludhiana
PUNJAB
141101
India |
| Phone |
8585925728 |
| Fax |
|
| Email |
shruti.dagar09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruti Dagar |
| Designation |
Assistant Professor, Optometrist |
| Affiliation |
Sankara Eye Hospital |
| Address |
Room no 10, department of refraction, Sankara eye hospital hospital, Ludhiana 141101
Room no 10, department of refraction, Sankara eye hospital hospital, Ludhiana 141101
Ludhiana
PUNJAB
141101
India |
| Phone |
8585925728 |
| Fax |
|
| Email |
shruti.dagar09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 10, department of refraction, sankara eye hospital, Ludhiana 141101 |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital |
| Address |
Room no 10, department of refraction, Sankara eye hospital hospital, Ludhiana 141101 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sankara Eye Hospital |
Ludhiana, Punjab |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kanak Shami |
Sankara eye hospital |
department of optometry, Sankara eye hospital, ludhiana
Ludhiana
PUNJAB |
8126595648
knksh03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sankara Eye Hospital Sri Kanchi Kamakoti Medical Trust Institutional Ethics Committee |
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 |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Community based cataract surgeries
2. Patients diagnosed with cataract
|
|
| ExclusionCriteria |
| Details |
1. Post cataract complications.
2. History of ocular diseases.
3. History of systemic disease.
4. History of Strabismus.
5. History of previous eye surgery or trauma
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess visual outcomes across different occupations |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess quality of life across different occupations |
12 months |
|
|
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)
|
29/11/2024 |
| 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
|
Study Title is Occupation-Specific Visual Outcomes and Quality of Life Post Cataract Surgery in a Community Setting. Introduction This study focuses on the impact of community-based cataract surgery on visual outcomes and quality of life, particularly how these factors vary across different occupations. Cataract surgery is the most common surgical procedure globally, yet in underserved rural areas, outcomes can be suboptimal, affecting both visual function and quality of life. the Aim is To evaluate how cataract surgery performed in a community setting influences patients quality of life based on occupational demands. Objectives are to Assess post-operative quality of life across different occupations using a quality of life questionnaire and Compare pre and post-surgery visual acuity, contrast sensitivity, and color vision. the study Design is Cross-sectional study with a sample size of 385 participants, conducted over 12 months at Sankara Hospital in Ludhiana. Visual function will be assessed using tools like the Snellen Chart, Ishihara color vision chart, and contrast sensitivity chart. Collected data will be analyzed with normative statistical tests in MS Excel.
|