The Asia Cornea Society Infectious Keratitis Study — ACSIKS  

Corneal Ulcer Clinical Trial

Official title: The Asia Cornea Society Infectious Keratitis Study

Status Recruiting

Clinical Trial Summary

Corneal diseases are a major cause of blindness worldwide, and corneal infections are a substantial cause of blindness in Asia. The aim of the Asia Cornea Society Infectious Keratitis Study (ACSIKS) is to study infectious keratitis (corneal infections) in Asian countries, so as to improve strategies for prevention and treatment, and to reduce the burden of blindness in Asia.

The first phase of ACSIKS is an 18-month observational study involving 11 eye hospitals in 8 Asian countries; these hospitals manage more than 6700 cases of corneal infections every year. From the first quarter of 2012, all patients with a corneal infection will be recruited and a standard ACSIKS protocol will be applied; this protocol includes the use of a common set of study forms and a suggested panel of microbiological examinations. However, each centre will be continue to treat their patients with the anti-infective therapy standard for their centre. Data will be recorded for each patient for a period of six months, including their medical and surgical management, the final clinical outcome and vision.

Bacterial and fungal growths from patients will also be stored for further research during a second phase of ACSIKS. These studies will focus on evaluating the resistance of the most common bacterial infections to the current available antibiotics, performing DNA testing to compare our strains with bacterial infections in the West, and to developing new diagnostic tests and anti-infective therapies tailored to corneal infections in Asia.

Clinical Trial 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 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. ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Corneal Ulcer
• Infection
• Keratitis

• NCT number: NCT01560208
• Study type: Observational
• Source: Asia Cornea Society
• Status: Recruiting
• Phase: N/A
• Start date: April 2012
• Completion date: October 2013