The Asia Cornea Society Infectious Keratitis Study

Summary

Participation Requirements

Description

Summary of the ACSIKS Clinical Protocol: All patients with an initial clinical diagnosis of infectious keratitis will be referred by the attending ophthalmologist-in-charge to an ACSIKS co-investigator or trial coordinator for recruitment into the study. Patients will be enrolled in the study after ...

Summary of the ACSIKS Clinical Protocol: All patients with an initial clinical diagnosis of infectious keratitis will be referred by the attending ophthalmologist-in-charge to an ACSIKS co-investigator or trial coordinator for recruitment into the study. Patients will be enrolled in the study after study informed consent is obtained and a trained interviewer will administer a standardized ACSIKS Clinical Case Report Form to each recruited subject. Information that will be documented would include the demographic profile (e.g. age, gender, ethnic group, occupation, etc), risk factors for infectious keratitis, presenting symptoms and prior treatment. Patients who are contact lens wearers will also complete a separate contact lens questionnaire, with specific questions on duration of contact lens wear, type of contact lens and solutions used, lens wear schedule and habits, and adherence to lens care practices. All patients will undergo a thorough ocular examination by the ophthalmologist-in-charge or an ACSIKS co-investigator, and details of the infectious keratitis and associated findings documented on the ACSIKS Clinical CRF. With the approval of the ophthalmologist-in-charge, corneal scrapings will then be collected as per the ACSIKS Microbiological Protocol. Each study subject will consequently still be managed by the ophthalmologist-in-charge according to his/her current clinical approach, with appropriate medical or surgical treatment carried out in accordance with the practice patterns and standards of his/her institution, and no attempt to deviate from current treatment practices. Regular chart reviews will be performed by ACSIKS trial coordinators for the six months duration of the subjects' involvement to document the initial differential diagnoses and medical treatment, the microbiological results, and any changes to the diagnosis and treatment. The last consultation with the ophthalmologist-in-charge during that six month-period will be taken as the final study review. Summary of the ACSIKS Microbiological Protocol: At the discretion of the ophthalmologist-in-charge, corneal scrapings will be collected based on a list of investigations suggested by the ACSIKS Group. All microbiological specimens will be incubated, interpreted and reported according to agreed upon common standards, regardless of the number of colonies present. Bacterial organisms will also be tested using standardized antibiograms agreed upon by microbiologists from the various participating institutions. Results of any and all microbiological testing will be collected and recorded into the ACSIKS Microbiological Case Report Form. If these samples do yield a positive growth of either fungal or bacterial organisms (or both), the causative organisms cultured will be sub-cultured and stored at each site's ACSIKS freezer, for subsequent transport to the ACSIKS Central Repository in Singapore for use in future microbial studies under Phase 2 of the ACSIKS project.

Tracking Information