| CTRI Number |
CTRI/2024/03/063437 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Knowledge, Attitude and Practice towards eye pressure disease in established eye pressure disease patients who are on treatment for more than one year. |
|
Scientific Title of Study
|
Knowledge, attitude and practice towards glaucoma in established glaucoma patients who are in treatment for more than one year. |
| 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 Preethi S R |
| Designation |
Primary DNB Resident |
| Affiliation |
Aravind Eye Hospital |
| Address |
21, Glaucoma Clinic, Aravind Eye Hospital
Cuddalore Main Road, Thavalakuppam, Pondicherry.
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9344517300 |
| Fax |
|
| Email |
preethisr69@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Upadhaya |
| Designation |
Medical consultant Glaucoma Services |
| Affiliation |
Aravind Eye Hospital |
| Address |
21, Glaucoma Clinic, Aravind Eye Hospital
Cuddalore Main Road, Thavalakuppam, Pondicherry.
Pondicherry
PONDICHERRY
605007
India |
| Phone |
8489810704 |
| Fax |
|
| Email |
swati.dr@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preethi S R |
| Designation |
Primary DNB Resident |
| Affiliation |
Aravind Eye Hospital |
| Address |
21, Glaucoma Clinic, Aravind Eye Hospital
Cuddalore Main Road, Thavalakuppam, Pondicherry.
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9344517300 |
| Fax |
|
| Email |
preethisr69@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry |
|
|
Primary Sponsor
|
| Name |
Dr Preethi S R |
| Address |
Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry.605007 |
| 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 Preethi S R |
Aravind Eye Hospital |
21, Glaucoma clinic, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry.605007
Pondicherry
PONDICHERRY |
9344517300
preethisr69@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Aravind Eye Hospital, Pondicherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H40-H42||Glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All glaucoma patients more than 18 years of age, who are on treatment for more than one year. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will help us to better understand the areas of gaps in knowledge among glaucoma patients and enable better targeting of awareness programmes. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
11/03/2024 |
| 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
|
Primary objective: To understand the glaucoma patient’s
knowledge about their disease progression and effect of this knowledge on their
attitude towards the disease and its management. Research question: What is the
level of knowledge that glaucoma patients have, being on treatment for more
than one year? What is
their way of approach (attitude and practice) towards the disease for leading a
good quality of life?
|