| CTRI Number |
CTRI/2024/11/077270 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
23/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to compare effect of silicon oil in eye of retinal detachment and comparison with normal eye of same patient |
|
Scientific Title of Study
|
A comparative interventional study of effect of silicon oil on peripapillary capillary perfusion in patients with rhegmatogenous retinal detachment at SMS hospital |
| 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 Raju Beniwal |
| Designation |
Resident doctor |
| Affiliation |
Sawai Man Singh medical College and hospital Jaipur Rajasthan |
| Address |
Gate no 6 charak bhawan upgraded department of ophthalmology Sawai Man Singh medical College and hospital Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9462964834 |
| Fax |
|
| Email |
hinaya1318@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagendra Shekhawat |
| Designation |
Senior professor |
| Affiliation |
Sawai Man Singh medical College and hospital Jaipur Rajasthan |
| Address |
Gate no 6 charak bhawan upgraded department of ophthalmology Sawai Man Singh medical College and hospital Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414138567 |
| Fax |
|
| Email |
drnshekhawat@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nagendra Shekhawat |
| Designation |
Senior professor |
| Affiliation |
Sawai Man Singh medical College and hospital Jaipur Rajasthan |
| Address |
Gate no 6 charak bhawan upgraded department of ophthalmology Sawai Man Singh medical College and hospital Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414138567 |
| Fax |
|
| Email |
drnshekhawat@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [None] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nagendra Shekhawat |
Upgraded department of ophthalmology |
Sawai Man Singh medical College and hospital Jaipur
Jaipur
RAJASTHAN |
9414138567
drnshekhawat@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H330||Retinal detachment with retinal break, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Optical coherence tomography angiography |
Comparison of peripapillary capillary perfusion at ONH after silicon oil removal surgery |
| Intervention |
Silicon Oil Removal Surgery |
After 3months of retinal detachment repair surgery silicon oil removal surgery done |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group 25 to 60 yrs
IOP between 10 to 21 mm Hg
Patients with rhegmatogenous retinal detachment surgery with silicon oil insertion and with normal other eye |
|
| ExclusionCriteria |
| Details |
Patients with recurrent retinal detachment
Patients with choroidal neovascularization or any other retinal vascular diseases
Patients with poor OCTA images with signal strength less than 40%
Had SOR combined with ERM peeling
Failed to complete follow up
Optic disc abnormalities
Any medical condition that could affect hemodynamics of eye
Poat operative complications e.g. VH, PVR, endophthalmitis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare changes in Radial peripapillary capillary perfusion after SOR in RRD patients using OCTA |
Before silicon oil removal and after that at 1 week, 1 month and 3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess changes in perfusion before and after SOR |
Baseline pre SOR
7 day
1 month
3 month |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/12/2024 |
| 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 Yet Recruiting |
| 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
|
A study to see changes in RPC perfusion after SOR in operated RRD patients with silicon oil insertion conducted at SMS Hospital Jaipur aimed to achieve objectives to compare pre and post SOR RPC perfusion at ONH by performing OCTA on operated RRD patients with SOI. Patients have been followed up after 7 days, 1 month and 3 months. Data collected would then be useful in comparing changes in RPC perfusion before and after SOR in patients of operated RRD with SOI. |