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CTRI Number  CTRI/2022/07/044246 [Registered on: 22/07/2022] Trial Registered Prospectively
Last Modified On: 26/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   To compare the bacterial keratitis patients infected with biofilm producing and non biofilm producing bacteria. 
Scientific Title of Study   Comparison of the clinico-microbiological features and outcomes in patients with bacterial keratitis caused by biofilm producing and non –biofilm producing bacteria  
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 Sujata Das 
Designation  Medical Director, DrishtiDaan Eye Bank 
Affiliation  Consultant, Cornea & Anterior Segment L V Prasad Eye Institute 
Address  Academic Block, Ground Floor Mithu Tulasi Chanrai Campus
Patia, Bhubaneswar
Khordha
ORISSA
751024
India 
Phone  06742653216  
Fax  06742653130   
Email  sujata.abani@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sujata Das 
Designation  Medical Director, DrishtiDaan Eye Bank 
Affiliation  Consultant, Cornea & Anterior Segment L V Prasad Eye Institute 
Address  Academic Block, Ground Floor Mithu Tulasi Chanrai Campus
Patia, Bhubaneswar

ORISSA
751024
India 
Phone  06742653216  
Fax  06742653130   
Email  sujata.abani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Akshat Jain 
Designation  DNB Resident 
Affiliation  L V Prasad Eye Institute 
Address  Academic Block, Ground Floor Mithu Tulasi Chanrai Campus
Patia, Bhubaneswar
Khordha
ORISSA
751024
India 
Phone  9799174555  
Fax  06742653130   
Email  jainakshat0998@gmail.com  
 
Source of Monetary or Material Support  
Hyderabad Eye Research Foundation 
 
Primary Sponsor  
Name  Hyderabad Eye Research Foundation  
Address  L V Prasad Eye Institute Mithu Tulasi Chanrai Campus Patia, Bhubaneswar Odisha, India 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sujata Das  L V PRASAD EYE INSTITUTE  Academic Block Ground Floor Clinical Research Department Mithu Tulasi Chanrai Campus Patia, Bhubaneswar
Khordha
ORISSA 		 06742653216
06742653130
sujata.abani@gmail.com 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H160||Corneal ulcer,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  The study includes patients of any age or sex diagnosed withculture positive bacterial keratitis 
 
ExclusionCriteria 
Details  1 Fungal keratitis
2 Culture negative keratitis
3 Photo keratitis
4 Neurotrophic keratitis
5 Exposure keratitis
6 Inflammatory keratitis like Mooren’s ulcer

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
•Proportion of patients with bacterial keratitis infected with biofilm positive and biofilm negative bacteria.
•Profile of antibiotic resistance in the bacterial isolates positive for biofilm and negative for biofilm.
•Comparison of the following clinical parameters in patients of bacterial keratitis with biofilm positive and biofilm negative bacteria.
oRate of corneal ulcer healed
oVisual acuity
oRate of patients with worsening despite treatment
oNeed for surgical intervention
 		 1st visit and last visit 
 
Secondary Outcome  
Outcome  TimePoints 
Type of bacteria causing bacterial keratitis will be assessed for, and it would be done based on microbiology report of corneal scrapping  1st visit 
 
Target Sample Size   Total Sample Size="119"
Sample Size from India="119" 
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)   29/07/2022 
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="1"
Months="6"
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  

Bacterial keratitis is an infection of cornea caused by invasion and multiplication of bacteriaassociated with inflammation of stroma .

Pain , redness, photophobia and blurred vision are typical symptoms. Bacterial keratitis cancomplicate to corneal scarring and even perforation, which can lead to total visual loss  .

Corneal opacity is the fifth leading cause of blindness globally, affecting approx. 6 million ofworldpopulation. Inaddition it is responsible for 1.5-2.0 million new cases of monocular

blindness highlighting an ongoing uncurbed burden on human health.

 Contact lens wear is the most common risk factor for bacterial keratitis in urbanized world,while in developing country like India, trauma with contaminated water, soil and vegetative

matter which deliver heavy microbial loads, foreign bodies and diverse microbiota to ocular surface  .The most common causative organism for bacterial keratitis is Staphylococcusspp.,

Streptococcus spp. and gram negative bacilli such as Pseudomonas spp., and many of themare associated with biofilm production  .

 Biofilm is a slimy layer of a extra cellular matrix made of polymeric substances, formed by sessile cells and can grow onto both biotic and abiotic surfaces.Biofilms form an architectural colony providing resistance not only against antibiotics but also against human

immune system. Biofilm provides protection to bacteria from altered pH, osmolarity, nutrient scarcity , mechanical forces and confers antibiotic resistance through numerous mechanisms, thus making these bacteria very dangerous and difficult to treat.

 
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