| CTRI Number |
CTRI/2024/12/078201 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Mobile Application] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The Impact of Post cataract surgery patient care management application |
|
Scientific Title of Study
|
The Impact of a Novel Mobile Application on Compliance, surveillance and post operative recovery and satisfaction in Cataract Surgery Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Likhita Movva |
| Designation |
Junior Resident |
| Affiliation |
Saveetha Medical College Hospital |
| Address |
Department of Ophthalmology, Ground floor, Saveetha Medical College Hospital,
Saveetha Nagar,
Thandalam- 602105,
Tamil Nadu
India
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8148667150 |
| Fax |
|
| Email |
likhita3116@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Supreeth Reddy Chiramana |
| Designation |
Assistant Professor ,Ophthalmology |
| Affiliation |
Saveetha Medical College Hospital |
| Address |
Department of Ophthalmology, Ground floor,Saveetha Medical College Hospital,
Saveetha Nagar,
Thandalam- 602105,
Tamil Nadu
India
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9642404048 |
| Fax |
|
| Email |
supreethreddy.ch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Supreeth Reddy Chiramana |
| Designation |
Assistant Professor ,Ophthalmology |
| Affiliation |
Saveetha Medical College Hospital |
| Address |
Department of Ophthalmology,Ground floor,Saveetha Medical College Hospital,
Saveetha Nagar,
Thandalam- 602105,
Tamil Nadu
India
TAMIL NADU
602105
India |
| Phone |
9642404048 |
| Fax |
|
| Email |
supreethreddy.ch@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College Hospital,SIMATS,Thandalam,Chennai,602105,INDIA. |
|
|
Primary Sponsor
|
| Name |
Likhita Movva |
| Address |
Saveetha Medical College Hospital,
Saveetha Nagar,
Thandalam, 602105 ,
Tamil Nadu ,India |
| 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 Likhita Movva |
SAVEETHA MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF OPHTHALMOLOGY,GROUND FLOOR,SAVEETHA MEDICAL COLLEGE AND HOSPITAL, SAVEETHA UNIVERSITY, THANDALAM, CHENNAI, 602105
Kancheepuram
TAMIL NADU |
8148667150
likhita3116@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College And Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H538||Other visual disturbances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mobile application for post cataract surgery patients |
the application helps with medication adherence and followup visits by sending reminders |
| Comparator Agent |
Post op visual outcome |
post op visual outcome, satisfaction ,pain score ,and post op complications were all compared between the 2 groups |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-underwent cataract surgery
-access to smartphone or tablet
-ability to understand and use technology |
|
| ExclusionCriteria |
| Details |
-severe visual impairment or blindness
-severe cognitive impairment
-any other vision impairing conditions other than cataract
-language literacy barriers
-participation in other interventional studies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improved medication adherence, increased attendance at followup appointments, enhanced visual acuity, greater patient satisfaction and engagement, reduced healthcare utilisation and complications. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| enhanced visual acuity, greater patient satisfaction and engagement, reduced healthcare utilisation and complications. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="360"
Sample Size from India="360"
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)
|
05/12/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
lntroduction:Cataract surgery is one of the most commonly performed surgeries worldwide, yet post-operative care and medication adherence has significant challenges. This research project aims to address these challenges by developing a mobile application to improve medication compliance, provide essential information, and support patients during their recovery process. Objectives:The primary objective of this research project is to develop a user-friendly mobile application specifically designed to assist post-cataract surgery patients in medication compliance and recovery management. Secondary objectives include evaluating the app’s usability, assessing its impact on medication adherence and recovery outcomes, and gathering feedback from patients and healthcare providers for further improvement. Outcome- The ultimate outcome of this research project is the development of a valuable tool that empowers post-cataract surgery patients to take control of their recovery process, leading to improved outcomes and enhanced quality of life. |