The Asia Cornea Society Infectious Keratitis Study

Corneal Ulcer Clinical Trial

— ACSIKS  

Official title:

The Asia Cornea Society Infectious Keratitis Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01560208
• Other study ID #: ACSIKS
• Status: Recruiting
• Phase: N/A
• First received: March 20, 2012
• Last updated: December 18, 2012
• Start date: April 2012
• Est. completion date: October 2013

Study information

• Verified date: December 2012
• Source: Asia Cornea Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Ministry of Health
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6750
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all patients presenting to an ACSIKS site during the study period with an initial diagnosis of infectious keratitis in one or both eyes

Exclusion Criteria:

• patients who are cognitively impaired or otherwise unable to give direct informed consent

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Corneal Ulcer
• Infection
• Keratitis

Locations

Country	Name	City	State
China	Shandong Eye Institute	Qingdao
China	Xiamen Eye Center	Xiamen
India	L.V.Prasad Eye Institute	Hyderabad	Andhra Pradesh
India	Aravind Eye Hospital	Madurai	Tamil Nadu
Japan	Department of Ophthalmology, Faculty of Medicine, Osaka University Graduate School of Medicine Hospital	Osaka
Japan	Department of Ophthalmology, Tottori University Hospital	Tottori
Korea, Republic of	Department of Opthalmology & Visual Science, The Catholic University of Korea, Seoul St. Mary's Eye Institute	Seoul
Philippines	Department of Ophthalmology and Visual Sciences, Philippine General Hospital	Manila
Singapore	Singapore Eye Research Institute	Singapore
Taiwan	Department of Opthalmology, National Taiwan University Hospital	Taipei City
Thailand	Department of Ophthalmology, Faculty of Medicine, Siriraj Hospital, Mahidol University	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Asia Cornea Society	Singapore Clinical Research Institute

Countries where clinical trial is conducted

China,  India,  Japan,  Korea, Republic of,  Philippines,  Singapore,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of infectious keratitis	Resolution of the infectious keratitis occurs when the infiltrate clears, epithelium heals over, and inflammation subsides.	6 months from enrollment	No
Secondary	Number of acute surgical interventions required.	Any form of surgery performed during the acute stage of the infection. The number and type of surgery performed and the surgical outcomes will be captured.	6 months from enrollment	No
Secondary	Visual acuity outcome of management.	Visual acuity will be documented. Reasons for poor visual acuity (less than 6/18 or 0.3) will be recorded.	6 months from enrollment	No