| CTRI Number |
CTRI/2022/04/042245 [Registered on: 28/04/2022] Trial Registered Prospectively |
| Last Modified On: |
26/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
prospective study of the incidence and risk factors of cystoid macular edema post vitrectomy for rhegmatogenous retinal detachment. |
|
Scientific Title of Study
|
Cystoid Macular Edema After Post Vitrectomy For Rhegmatogenous Retinal Detachment: A Prospective Study
|
| 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 Mukesh Jain |
| Designation |
Consultant, Vitreo-Retinal Services |
| Affiliation |
L V Prasad Eye Institute |
| Address |
Academic Block,
First Floor
Mithu Tulsi Chanrai Campus,
At-Patia
Po-KIIT
Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9786022417 |
| Fax |
06742653130 |
| Email |
jainmukesh@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Jain |
| Designation |
Consultant, Vitreo-Retinal Services |
| Affiliation |
L V Prasad Eye Institute |
| Address |
Academic Block,
First Floor
Mithu Tulsi Chanrai Campus,
At-Patia
Po-KIIT
Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9786022417 |
| Fax |
06742653130 |
| Email |
jainmukesh@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
Mohammed Hasibur Rahman |
| Designation |
Clinical Research Supervisor |
| Affiliation |
L V Prasad Eye Institute |
| Address |
Academic Block,
Ground Floor
Mithu Tulsi Chanrai Campus,
At-Patia
Po-KIIT
Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9937278658 |
| Fax |
06742653130 |
| Email |
hasiburrahman@lvpei.org |
|
|
Source of Monetary or Material Support
|
|
Hyderabad Eye Research Foundation |
|
|
Primary Sponsor
|
| Name |
Hyderabad Eye Research Foundation |
| Address |
L V Prasad Eye Institute
Mithu Tulsi Chanrai Campus, Patia, Bhubaneswar
|
| Type of Sponsor |
Research institution |
|
|
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 Mukesh Jain |
L V PRASAD EYE INSTITUTE |
Academic Block, Ground Floor Clinical Research Department Mithu Tulsi Chanrai Campus Patia Bhubaneswar
Khordha
ORISSA |
9786022417
06743987130
jainmukesh@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, L V Prasad Eye Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H338||Other retinal detachments, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Prednisolone Eye Drops (1%)
|
Prednisolone Eye Drops (1%)- 4 Times a
day for duration of 3 weeks.
|
| Intervention |
Dorzolamide Eye Drops (2%) |
Dorzolamide Eye Drops (2%)-3 Times a day for duration of 3 weeks |
| Comparator Agent |
NA |
NA |
| Intervention |
Nepafenac Eye Drops (0.1%) |
Nepafenac Eye Drops(0.1%)- 3 times a day for duration of 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 to 70 years
2. All cases of rhegmatogenous retinal detachments
which undergo pars-plana vitrectomy using 23 g
vitrectomy system.
3. Follow up for 6 months following cataract
surgery.
4. Only cases with Silicone oil tamponade/ SF6
injection will be taken to facilitate
the post-operative OCT in follow up. |
|
| ExclusionCriteria |
| Details |
1. Patients with retinal vascular disorders
2. Patients with uveitis
3. Patients with myopic retinoschisis
4. Patients with AMD or PCV or other macular conditions unrelated to retinal
detachment.
5. With co-existing retinal dystrophies
6. Case with combined retinal detachment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the incidence and risk factors of the cystoid macular edema post
vitrectomy for rhegmatogenous retinal detachment |
Post-operative 3 weeks, 3 months
and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| INCIDENCE OF ER POST PPV IN RD S |
3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/05/2022 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
CME POST CATARATC SURGERY LEADS TO SUB-OPTICAL OUTCOMES. THE INCIDENCE OF THE SAME POST VITRECTOMY HAS NOT BE PROSPECTIVELY STUIDED. WE AIM TO STUDY THE INCIDENCE AND RISK FACTORS FOR THE SAME POST PPV IN RHEGMATOGENOUS RD |