| CTRI Number |
CTRI/2024/01/061740 [Registered on: 23/01/2024] Trial Registered Prospectively |
| Last Modified On: |
25/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Quality of Life among Cataract Patients |
|
Scientific Title of Study
|
Quality of Life among Cataract Patients in a selected hospital Mangaluru |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashritha Mendon |
| Designation |
Undergraduate Student |
| Affiliation |
FATHER MULLER COLLEGE OF NURSING |
| Address |
Father Muller College of Nursing
Father Muller Road
Kankanady
Mangaluru
Father Muller College of Nursing
Father Muller Road
Kankanady
Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
7676389589 |
| Fax |
|
| Email |
rpractical219@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashritha Mendon |
| Designation |
Undergraduate Student |
| Affiliation |
FATHER MULLER COLLEGE OF NURSING |
| Address |
Father Muller College of Nursing
Father Muller Road
Kankanady
Mangaluru
Father Muller College of Nursing
Father Muller Road
Kankanady
Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
7676389589 |
| Fax |
|
| Email |
rpractical219@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Precilla Dsilva |
| Designation |
Associate Professor |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing
Father Muller Road
Kankanady
Mangaluru
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9731873891 |
| Fax |
|
| Email |
precilladsilva25@fathermuller.in |
|
|
Source of Monetary or Material Support
|
| Father Muller Research Center Mangaluru |
|
|
Primary Sponsor
|
| Name |
Father Muller Research Center |
| Address |
Father Muller College of Nursing
Father Muller Road
Kankanady
Mangaluru |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Annmaria Babu |
Father Muller College of Nursing
Father Muller Road
Kankanady
Mangaluru |
| Ans Maria Joy |
Father Muller College of Nursing
Father Muller Road
Kankanady
Mangaluru |
| Anupama Johnson |
Father Muller College of Nursing
Father Muller Road
Kankanady
Mangaluru |
| Arya Raphel |
Father Muller College of Nursing
Father Muller Road
Kankanady
Mangaluru |
| Ashmitha Rodrigues |
ather Muller College of Nursing
Father Muller Road
Kankanady
Mangaluru |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Precilla Dsilva |
Father Muller Medical College Hospital |
Opthalmalogy OPD number 28 , Ophthalmology wards
Father Muller Medical College Hospital
Father Muller Road
Kankanady
Mangaluru
Dakshina Kannada
KARNATAKA |
9731873891
precilladsilva25@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Comitte |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H258||Other age-related cataract, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed with single or both eye cataract |
|
| ExclusionCriteria |
| Details |
Patients who are mentally unstable |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life among cataract patients (QOL) |
Visual Quality of life scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between QOL and sample characteristics |
significant association |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
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)
|
26/01/2024 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Published in Manipal Journal of Nursing and Health Sciences |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Cataracts are a leading global cause of blindness that steadily worsen over time . Cataract causes clouded, blurry, or dim vision, increased difficulties seeing at night, sensitivity to light and glare, difficulty reading, retreat from social activities, and sense of pessimism makes the people difficult to engage in their day today life activities. In addition to these, cataract has a greater impact on older adults, including increased depression, social isolation, and a risk of falls and fractures, as well as insomnia-related symptoms, such as reduced sleep quality and duration, which may worsen the patients’ quality of life. Cataracts are the main cause of vision impairment in India, accounting for more than 73.8% of cases in the North and 71.8% in the South. The average incidence of cataract is nearly 3.8 million. This disease usually affects infants, adults, and older people above. |