Microbial Keratitis in Cairo University Hospitals

Sponsor

Kasr El Aini Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05387993

Collaborator

(none)

Enrollment

Location

9.1

Actual Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study was to identify the incidence of infective keratitis presenting to the ophthalmology emergency department at Cairo University hospital, the risk factors and the bacterial/fungal spectrum causing the ulcers and to determine the best possible empirical therapy followed by specific therapy after obtaining culture results.

Condition or Disease	Intervention/Treatment	Phase
Infective Keratitis

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

85 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Incidence, Risk Factors and Microbiological Features of Infective Keratitis in Cairo University Hospitals

Actual Study Start Date :

Sep 10, 2020

Actual Primary Completion Date :

May 30, 2021

Actual Study Completion Date :

Jun 15, 2021

Outcome Measures

Primary Outcome Measures

To identify risk factors and the most common causative organisms of microbial keratitis among the Egyptian population through history taking from each patient and the results of corneal sampling taken from the ulcer. [Three weeks for each participant]
Thorough history taking including risk factors that contributed to the ulcer occurrence. Corneal sampling through corneal scraping from the base and edge of the ulcer that undergoes direct examination and culturing using standard laboratory protocols.
To detect incidence of infective keratitis amongst all ophthalmological casualty cases by documenting the number of cases presenting or referred to the casualty of the ophthalmology department. [through study completion, an average of eight months]
Noting down the number of patients diagnosed with microbial keratitis that present to the casualty of a tertiary referral hospital, and calculate the percentage amongst all other ophthalmic casualty cases that present to the emergency as well.
To detect antimicrobial susceptibility and resistance of different antimicrobial agents causing corneal infections in our study group. [two weeks for each participant]
Antibiotic susceptibility testing was performed by the disc diffusion method (Modified Kirby Bauer technique) using Muller Hinton agar, aerobic incubation at 35°C for 16-18 hours. Anti fungal susceptibility was done using microdilution testing following the CLSI reference method.

Secondary Outcome Measures

To assess the impact of culture and sensitivity results of corneal scrapings on the initial empirical therapy by calculating the number of cases that needed to shift the initial therapy to another one according to the antimicrobial susceptibility. [six months]
Empirical therapy according to the clinical impression that was shifted to another therapy according to the specific sensitivity results of positive growth cases.
Improving lines of management of microbial keratitis for a better outcome based on the cooperation between clinical ophthalmologists and microbiologists to reach a proper diagnosis and tailor the management accordingly. [six months]
Clinical impression of the nature of microbial keratitis , combined with the results of corneal scrapings positive growth cultures to detect the proper management plan for each patient to increase the chances of healed ulcers with medical therapy. Calculating the number of improving, healed and complicated cases.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients presenting at the casualty who are clinically diagnosed as infectious keratitis , of all age groups and including both genders.

Exclusion Criteria:

Patients presenting with clinical picture suggestive of

Viral keratitis solely without superimposed secondary infection.
Non infectious keratitis as peripheral ulcerative keratitis ( e.g. Mooren's ulcer, marginal keratitis, autoimmune keratitis )