To compare the bacterial keratitis patients infected with biofilm producing and non biofilm producing bacteria.

Recruiting

• Conditions: Corneal ulcer,

• Registration Number: CTRI/2022/07/044246
• Lead Sponsor: Hyderabad Eye Research Foundation

Brief Summary

Bacterial keratitis is an infection of cornea causedby invasion and multiplication of bacteriaassociated with inflammation ofstroma .

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

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

blindness highlighting an ongoing uncurbed burden onhuman health.

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

matter which deliver heavy microbial loads, foreignbodies and diverse microbiota to ocular surface  .The most common causative organism forbacterial keratitis is Staphylococcusspp.,

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

Biofilm is a slimy layer of a extra cellular matrixmade of polymeric substances, formed by sessile cells and can grow onto bothbiotic and abiotic surfaces.Biofilms form an architectural colony providingresistance not only against antibiotics but also against human

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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-07-26
• Study Start: 2022-07-29

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

The study includes patients of any age or sex diagnosed withculture positive bacterial keratitis.

Exclusion Criteria

1 Fungal keratitis 2 Culture negative keratitis 3 Photo keratitis 4 Neurotrophic keratitis 5 Exposure keratitis 6 Inflammatory keratitis like Mooren’s ulcer.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Proportion of patients with bacterial keratitis infected with biofilm positive and biofilm negative bacteria.	1st visit and last visit
•Profile of antibiotic resistance in the bacterial isolates positive for biofilm and negative for biofilm.	1st visit and last visit
•Comparison of the following clinical parameters in patients of bacterial keratitis with biofilm positive and biofilm negative bacteria.	1st visit and last visit
oRate of corneal ulcer healed	1st visit and last visit
oVisual acuity	1st visit and last visit
oRate of patients with worsening despite treatment	1st visit and last visit
oNeed for surgical intervention	1st visit and last visit

Secondary Outcome Measures

Name	Time	Method
Type of bacteria causing bacterial keratitis will be assessed for, and it would be done based on microbiology report of corneal scrapping	1st visit

Trial Locations

Locations (1)

L V PRASAD EYE INSTITUTE; 🇮🇳 Khordha, ORISSA, India

L V PRASAD EYE INSTITUTE

🇮🇳Khordha, ORISSA, India

Dr Sujata Das

Principal investigator

06742653216

sujata.abani@gmail.com