| CTRI Number |
CTRI/2024/03/064649 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Accounting the number of patients with Glaucoma, among those attending Community outreach camps |
|
Scientific Title of Study
|
Prevalence of Glaucoma in patients attending Community outreach camps |
| 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 Patibanda Durga Subha Keerthi |
| Designation |
Fellow in Glaucoma |
| Affiliation |
Sankara Eye Hospital |
| Address |
Department of Glaucoma, Sankara Eye Hospital, Pedakakani, Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8500544905 |
| Fax |
|
| Email |
sk.patibanda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Malleswari M |
| Designation |
Consultant Glaucoma |
| Affiliation |
Sankara Eye Hospital |
| Address |
Department of Glaucoma, Sankara Eye hospital, Pedakakani, Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9493714701 |
| Fax |
|
| Email |
malleswari6372@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Patibanda Durga Subha Keerthi |
| Designation |
Fellow in Glaucoma |
| Affiliation |
Sankara Eye Hospital |
| Address |
Department of Glaucoma, Sankara eye hospital, Pedakakani, Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8500544905 |
| Fax |
|
| Email |
sk.patibanda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patients attending Community outreach camps conducted by Sankara Eye hospital, Guntur |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital, Pedakakani, Guntur |
| Type of Sponsor |
Research institution and hospital |
|
|
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 PDS Keerthi |
Sankara Eye Hospital |
Department of Glaucoma, Sankara Eye Hospital ,Pedakakani, Guntur
Guntur
ANDHRA PRADESH |
8500544905
sk.patibanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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: H42||Glaucoma in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients of age above 40 years, attending Community outreach camps |
|
| ExclusionCriteria |
| Details |
Patients with acute infective conditions |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the prevalence of Glaucoma among patients attending Community outreach camps |
Study is done over a period of 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the undiagnosed Glaucoma cases, to identify different subtypes of Glaucoma, to identify potential risk factors |
3 months |
|
|
Target Sample Size
|
Total Sample Size="2500"
Sample Size from India="2500"
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)
|
01/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/04/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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
|
ALL
PATIENTS FOUND TO HAVE
- RAISED IOP
- SHALLOW PERIPHERAL ANTERIOR CHAMBER
DEPTH
- GLAUCOMATOUS OPTIC DISC CHANGES
- KNOWN CASES OF GLAUCOMA
ARE EVALUATED IN DETAIL IN GLAUCOMA
CLINIC |