| CTRI Number |
CTRI/2023/05/052747 [Registered on: 17/05/2023] Trial Registered Prospectively |
| Last Modified On: |
16/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
hospital based |
| Study Design |
Other |
|
Public Title of Study
|
TOTAL NUMBER CASES AND CAUSATIVE AGENT OF GLAUCOMA IN TERTIARY EYE CARE CENTRE |
|
Scientific Title of Study
|
PREVALENCE AND RISK FACTORS OF GLAUCOMA IN A TERTIARY EYE CARE CENTRE-A hospital based prospective study |
| Trial Acronym |
NO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KAJAL PRIYA |
| Designation |
GLAUCOMA FELLOW |
| Affiliation |
sankara eye hospital |
| Address |
GLAUCOMA DEPARTMENT
SANKARA EYE HOSPITAL GUNTUR
VIJAYAWADA EXPRESSWAY PEDAKAKANI
GUNTUR
ANDHRA PRADESH
522509
INDIA
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8826722272 |
| Fax |
|
| Email |
kajalpriya965@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MALLESWARI MEDIKONDA |
| Designation |
GLAUCOMA CONSULTANT |
| Affiliation |
SANKARA EYE HOSPITAL |
| Address |
DEPARTMENT OF GLAUCOMA
SANKARA EYE HOSPITAL GUNTUR
VIJAYAWADA EXPRESSWAY PEDAKAKANI
GUNTUR
ANDHRA PRADESH
522509
INDIA
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9493714701 |
| Fax |
|
| Email |
malleswari6372@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MALLESWARI MEDIKONDA |
| Designation |
GLAUCOMA CONSULTANT |
| Affiliation |
SANKARA EYE HOSPITAL |
| Address |
DEPARTMENT OF GLAUCOMA
SANKARA EYE HOSPITAL GUNTUR
VIJAYAWADA EXPRESSWAY PEDAKAKANI
GUNTUR
ANDHRA PRADESH
522509
INDIA
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9493714701 |
| Fax |
|
| Email |
malleswari6372@gmail.com |
|
|
Source of Monetary or Material Support
|
| SANKARA EYE HOSPITAL, GUNTUR ( all patients attending OPD and outreach department of sankara eye hospital) |
|
|
Primary Sponsor
|
| Name |
SANKARA EYE HOSPITAL |
| Address |
DEPARTMENT OF GLAUCOMA
SANKARA EYE HOSPITAL GUNTUR
VIJAYAWADA EXPRESSWAY PEDAKAKANI
GUNTUR
ANDHRA PRADESH
522509
INDIA |
| 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 KAJAL PRIYA |
SANKARA EYE HOSPITAL |
DEPARTMENT OF GLAUCOMA
SANKARA EYE HOSPITAL GUNTUR
VIJAYAWADA EXPRESSWAY PEDAKAKANI
GUNTUR
ANDHRA PRADESH
522509
INDIA
Guntur
ANDHRA PRADESH |
8826722272
kajalpriya965@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H40||Glaucoma, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients attending opd and outreach dapartment of Sankara Eye Hospital of any age |
|
| ExclusionCriteria |
| Details |
1. patients with neurological disc changes only without glaucomatous change i.e primary and secondary optic atrophy
2. abnormal disc morphology mimicking glaucoma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to study the prevalence and associated risk factors of glaucoma in tertiary eye care hospital in south india |
at the time of presentation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the prevalence of different types of glaucoma in urban and rural subjects in Southern India
2.To study the associated risk factors of different subtypes of glaucoma
|
at the time of presentation |
|
|
Target Sample Size
|
Total Sample Size="425"
Sample Size from India="425"
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)
|
01/06/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Glaucoma is the leading cause of irreversible blindness and second leading cause of blindness. The global prevalence of glaucoma is estimated at 3.54%. The estimated prevalence of glaucoma cases in India is reported to be 11.9 million. Purpose of this study to know the prevalence and associated risk factors of different types of glaucoma in patients attending the tertiary eye care hospital in south India So we can improve the screening techniques to identify the glaucoma patients early our study include patients of all age group, who will present in opd and outreach department of Sankara eye hospital , Guntur. A detailed history will be taken, complete ophthalmological examination will be done. all patients who were suspicious of glaucoma wiil be examined by VOLK’S 4 mirror gonioprism and will be attempted for automated visual field analysis and central corneal thickness examination |