| CTRI Number |
CTRI/2019/02/017876 [Registered on: 28/02/2019] Trial Registered Prospectively |
| Last Modified On: |
18/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Endophthalmitis Management Study |
|
Scientific Title of Study
|
"The Endophthalmitis Management (EMS):The results of inflammatory score based management of post operative endophthalmitis"
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vivek Dave |
| Designation |
Consultant-Ophthalmologist |
| Affiliation |
LV Prasad Eye Institute |
| Address |
LV Prasad Eye Institute,
Kallam Anji Reddy Campus,
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana.
Hyderabad
TELANGANA
500034
India |
| Phone |
04030612656 |
| Fax |
04023548271 |
| Email |
vivekdave@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Dave |
| Designation |
Consultant-Ophthalmologist |
| Affiliation |
LV Prasad Eye Institute |
| Address |
LV Prasad Eye Institute,
Kallam Anji Reddy Campus,
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana.
LV Prasad Eye Institute,
Kallam Anji Reddy Campus,
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana.
Hyderabad
TELANGANA
500034
India |
| Phone |
04030612656 |
| Fax |
04023548271 |
| Email |
vivekdave@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivek Dave |
| Designation |
Consultant-Ophthalmologist |
| Affiliation |
LV Prasad Eye Institute |
| Address |
LV Prasad Eye Institute,
Kallam Anji Reddy Campus,
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana.
Hyderabad
TELANGANA
500034
India |
| Phone |
04030612656 |
| Fax |
04023548271 |
| Email |
vivekdave@lvpei.org |
|
|
Source of Monetary or Material Support
|
| L V Prasad Eye Institute,
Kallam Anji Reddy Campus,
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana. |
|
|
Primary Sponsor
|
| Name |
L V Prasad Eye Institute |
| Address |
LV Prasad Eye Institute,
Kallam Anji Reddy Campus,
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad,Telangana
Hyderabad-500034,
Telangana. |
| Type of Sponsor |
Other [Non Profitable organization] |
|
|
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 Vivek Dave |
LV Prasad Eye Institute |
LV Prasad Eye Institute,
Kallam Anji Reddy Campus,
L.V Prasad Marg,
1st floor, GPR Building,Room No:123,Clinical Research Department
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana.
Hyderabad
TELANGANA |
04030612656
04023548271
vivekdave@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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: H308||Other chorioretinal inflammations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1.Ceftazidime
2. Amphotericin |
1.Imipenam
2.voriconazole |
| Intervention |
Intravitreal Antibiotics |
Empirically one arm will be injected with intavitreal vancomycin + Ceftazidime and other arm will be injected with vancomycin + Imipenem.
If fungus is detected, one arm will be injected with intravitreal Amphotericin B and other arm with intravitreal Voriconazole |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinical signs and/or symptoms of endophthalmitis (bacterial and fungal)
2. Post surgical endophthalmitis cases following any intraocular surgery
3. Visual acuity from 6/12 to Light perception
4 Signed consent
|
|
| ExclusionCriteria |
| Details |
1.Patient 18 years or younger
2. One eyed person
3. Unfit for surgery
4. Retina detached at time of presentation (indirect ophthalmoscopy/ ultrasonography)
5.Lack of signed consent
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of BCVA at one month by 2 lines or more |
1 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Decrease in Inflammatory score at the end of 1 month
2.Retinal detachment any time within 3 months
3.Hypotony 5 mm Hg between 1- 3 months
4.Loss of BCVA by 2 lines or more at the end of 1 month
|
1 Month |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
25/03/2019 |
| 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="3"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The current study, the Endophthalmitis Management Study is a prospective
randomized clinical trial. In this study, cases of post-operative
endophthalmitis will be graded in the retina clinic based on a pre-decided
inflammatory score. Based on the score, the patients will be advised either a
vitreous tap procedure or a pars plana vitrectomy. In each group patients will
be randomized to either the standard empirical intravitreal injection
combination of vancomycin+ceftazidime or
vancomycin+imipenem. In cases where microbiologic work up reveals fungal
elements, the patients will be randomized to receive either Amphotericin B or
Voriconazole. The patients will be followed up as per set schedule till 3
months. The cases will be evaluated for the primary and secondary outcome
measures as described in the protocol.
|