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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Outcome  TimePoints 
NA  Na 
 
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. 

 
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