| CTRI Number |
CTRI/2020/06/025685 [Registered on: 08/06/2020] Trial Registered Prospectively |
| Last Modified On: |
05/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
to find out how effective ultrasound is in determining glaucoma in patients with unclear cornea |
|
Scientific Title of Study
|
Correlation of clinical and ultrasonographic evaluation of optic nerve head cupping in patients with clear media and opaque cornea |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Simran chhabra |
| Designation |
Junior resident |
| Affiliation |
Government medical college and hospital, sector 32 chandigarh |
| Address |
eye office D block level 3, Government medical college and hospital, sector 32 chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
8860684022 |
| Fax |
|
| Email |
simranchhabra14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr suresh kumar |
| Designation |
Professor and head of department |
| Affiliation |
Department of ophthalmology Government medical college and hospital, sector 32 chandigarh |
| Address |
D block level 3, Department of ophthalmology Government medical college and hospital, sector 32 chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121588 |
| Fax |
|
| Email |
drsuresh.kumar.gupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr simran chhabra |
| Designation |
Junior resident |
| Affiliation |
Department of ophthalmology, Government medical college and hospital, sector 32 chandigarh |
| Address |
D block level 3, Department of ophthalmology, Government medical college and hospital, sector 32 chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
8860684022 |
| Fax |
|
| Email |
simranchhabra14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of ophthalmology, government medical college and hospital, sector 32, chandigarh |
|
|
Primary Sponsor
|
| Name |
Department of ophthalmology |
| Address |
government medical college and hospital sector 32 chandigarh |
| Type of Sponsor |
Government medical college |
|
|
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 Simran Chhabra |
Government medical college and hospital, sector 32, chandigarh |
Block d level 3, Department of ophthalmolgyGovernment medical college and hospital, sector 32, chandigarh
Chandigarh
CHANDIGARH |
8860684022
simranchhabra14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee (GMCH, Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H409||Unspecified glaucoma, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Cooperative patients and patients consenting for examination
Group 1 patients with centrally opaque cornea ( leucomatous opacity, healed keratitis, vascularized failed grafts )
Group 2 All patients with established glaucoma and disc suspects with clear media |
|
| ExclusionCriteria |
| Details |
For patients with clear media
Tilted discs
Refractive error more than 5D
Cylindrical astigmatism more than 2 D at any axis
Any other optic neuropathy ( optic neuritis, non glaucomatous optic disc cupping, AION) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To sonographically pick up glaucomatous optic disc cupping in patients with opaque cornea especially if optic disc cupping is more than 0.7
To conpare ophthalmoscopic cup to disc ratiowith sonographic vertical optic disc diameter in patients with clearedia |
At presentation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
08/06/2020 |
| 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="6"
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)?
|
|
Brief Summary
|
The present study is being undertaken to identify and evaluate sonographic optic disc diameter in patients with opaque cornea and compare it with patients with clear media. It will also compare the accuracy of ultrasound in picking up optic cup ratios in patients with various optic disc size |