| CTRI Number |
CTRI/2025/09/094153 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
EIMA Imaging tool is a tool to identify infection of the inner cavity of the eye after cataract surgery (endophthalmitis) before further microbiology confirmation |
|
Scientific Title of Study
|
Validating the Endophthalmitis Infectivity Measurement Algorithm (EIMA) Imaging tool |
| 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 Taraprasad Das |
| Designation |
consultant, opthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
Kallam Anji Reddy Campus,GPR Building, Room No:207,1st floor,Clinical Research Department, L V Prasad Marg, Banjara Hills, Road No:02,Hyderabad
Hyderabad TELANGANA 500034 India |
| Phone |
9848303571 |
| Fax |
|
| Email |
tpd@lvpei.org |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Taraprasad Das |
| Designation |
consultant, opthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
Kallam Anji Reddy Campus,GPR Building, Room No:207,1st floor,Clinical Research Department, L V Prasad Marg, Banjara Hills, Road No:02,Hyderabad
Hyderabad TELANGANA 500034 India |
| Phone |
9848303571 |
| Fax |
|
| Email |
tpd@lvpei.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Taraprasad Das |
| Designation |
consultant, opthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
Kallam Anji Reddy Campus,GPR Building, Room No:207,1st floor,Clinical Research Department, L V Prasad Marg, Banjara Hills, Road No:02,Hyderabad
Hyderabad TELANGANA 500034 India |
| Phone |
9848303571 |
| Fax |
|
| Email |
tpd@lvpei.org |
|
|
Source of Monetary or Material Support
|
| Hyderabad Eye Research Foundation,L V Prasad Eye Institute |
|
|
Primary Sponsor
|
| Name |
Hyderabad Eye Research Foundation |
| Address |
L V Prasad Eye Institute
Kallam Anji Reddy Campus, L V Prasad Marg, Banjara Hills, Road No:02,Hyderabad 500 034, Telangana, India
|
| Type of Sponsor |
Other [Non Profitable Organization] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kim Ramasamy |
Aravind Eye Care System |
Retina Division,Clinical Research Department, 1, Anna Nagar, Madurai, Tamil Nadu - 625 020 Madurai TAMIL NADU |
91 452 435 6100
kim@aravind.org |
| Manisha Agarwal |
Dr Shroff Charity Eye |
Retina Division,Clinical Research Department,5027, Kedarnath Ln, opposite DAV School, Daryaganj, Delhi, 110002 Central DELHI |
98115 84615
agarwalmannii@yahoo.co.in |
| Sucheta Kulkarni |
HV Desai Eye Hospital |
Retina Division,Clinical Research Department,93, Tarawade Vasti, Mohammadwadi, Hadapsar, Pune, Maharashtra 411060 Pune MAHARASHTRA |
95033 81879
drsucheta.kulkarni@gmail.com |
| Anup Kelgaonkar |
L V Prasad Eye Institute |
Retina Division,Clinical Research Department,Mithu Tulsi Chanrai Campus, Patia Rd, Bhubaneswar, Odisha 751024 Khordha ORISSA |
83697 91276
dranupkelgaonkar@lvpei.org |
| Ashwini Kulkarni |
L V Prasad Eye Institute |
Retina Division,Clinical Research Department,Kode Venkatadri Chowdary Campus, 6-46, Tadigadapa - Penamaluru Rd, Tadigadapa, Poranki, Vijayawada, Andhra Pradesh 521134 Krishna ANDHRA PRADESH |
70304 80404
ashwini.kulkarni@lvpei.org |
| Dr Taraprasad Das |
L V Prasad Eye Institute |
Room No:207, 1st floor, GPR building, Clincial Research Department,Kallam Anji Reddy Campus, L V Prasad Marg, Banjara Hills, Road No:02, Hyderabad 500034
Hyderabad TELANGANA |
9848303571
tpd@lvpei.org |
| Thomas Cherian |
Little Flower Eye Hospital |
Retina Division, Clinical Research Department,SH1,Angamaly Ernakulam KERALA |
9388605608
tcherian.retina@gmail.com |
| Anil B Gangwe |
MGM Eye Institute |
Retina Division,Clinical Research Department,5th Mile, Vidhan Sabha Road, Saddu Rd, Raipur, Chhattisgarh 493111 Raipur CHHATTISGARH |
77129 70670
anil@mgmeye.org |
| Alok Sen |
Sadguru Netra Chikitsalaya |
Retina Division,Clinical Research Department,Sri Sadguru Seva Sangh Trust, Janki Kund, Chitrakoot, Madhya Pradesh 485334 Satna MADHYA PRADESH |
78982 01605
draloksen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Dr.Shroff Charity Eye Hospital Ethics Committee |
Approved |
| Ethical Committee |
Approved |
| Institute Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| L V Prasad Eye Institute, Ethics Committee |
Approved |
| L V Prasad Eye Institute, Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H301||Disseminated chorioretinal inflammation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
No |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults more than 40 years in age post-age related cataract endophthalmitis.
2. Endophthalmitis occurring within six weeks of standard (small incision or phacoemulsification) cataract surgery.
|
|
| ExclusionCriteria |
| Details |
1. Cataract other than age-related cataract
2. People under 40
3. Cataract surgery other than small incision and phacoemulsification
4. Endophthalmitis occurring after six weeks of cataract surgery
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Algorithmic Scoring to differentiate infection from non infection |
Only one visit (Screening) |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="289" Sample Size from India="289"
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)
|
17/09/2025 |
| 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="2" Months="1" Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Endophthalmitis after cataract surgery is rare but a potentially blinding condition if not recognised and treated early. The Endophthalmitis Vitrectomy Study (EVS)- guided current management strategies of acute endophthalmitis after cataract surgery are microbiological workup of undiluted vitreous, intravitreal antibiotics in all patients and vitrectomy in eyes with poor presenting vision. If required, the treatment is revised after the culture-susceptibility report is available, usually in three to five days. Two important criteria in decision-making are the culture positivity and the presenting vision. The clinical course and features of culture-negative endophthalmitis (other than the toxic anterior segment syndrome) are likely to have different severity of the symptoms and signs than the culture-positive ones. It is challenging to differentiate culture-positive endophthalmitis from culture-negative endophthalmitis from the presenting vision alone. Poor presenting vision could be due to media opacity, such as corneal edema and inflammatory exudates in the pupillary area. Like infection, inflammation plays an equally important role in endophthalmitis. The inflammatory cascade activated by specific toxic effects of the pathogen ultimately determines the final anatomical and functional outcome. Anticipation of infectivity based on the clinical clues at presentation could help the treating ophthalmologist choose an initial treatment close to the final treatment before the microbiology reports are available. We hypothesize that the presenting vision (a surrogate measure for severity of infection) and the presenting inflammation score (a surrogate measure for inflammation) together are likely to differentiate infectious from non-infectious endophthalmitis. Using the clinical clues we have developed to quantify inflammation in acute post-cataract endophthalmitis. The Inflammation score (IS) is measured from the at-presentation clinical status of four ocular tissues: cornea (clarity and abscess), anterior chamber (flare/cell and fibrin/hypopyon), iris (blood vessels, exudates over iris), and vitreous (flare, and opacities). The scoring was done from 0 to 4 in each category, with an additional allowance for poor ocular tissue clarity. The IS has been earlier used and validated and is currently used in the Endophthalmitis Management Study (EMS, a prospective randomized clinical trial) Using large retrospective data, we constructed the Endophthalmitis Infectivity Measurement Algorithm (EIMA) to identify and differentiate infective from non-infective post-cataract surgery acute endophthalmitis. We validated it with a set of prospective data. |