Clinical trial NCT01560208: The Asia Cornea Society Infectious Keratitis Study
Official title: The Asia Cornea Society Infectious Keratitis Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Corneal Ulcer
Keywords: infectious keratitis
infective keratitis
prospective multicentre study
Asia
Lead sponsor: Asia Cornea Society
Sponsor class: OTHER
Collaborators: name: Singapore Clinical Research Institute
First posted: 2012-03-22
Enrollment: 6750
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ACSIKS will recruit all patients with infectious keratitis from 11 Study Centres in eight different countries (India, China, Japan, South Korea, Taiwan, Thailand, the Philippines and Singapore), each evaluating all cases of infectious keratitis presenting over a 12 month period.

There will be a total of 11 Study Centres¸ with India, China and Japan each having 2 separate study centres. Some Study Centres will also be responsible for coordinating cases accrued from affiliated hospitals ("Participating Institutions").

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Resolution of infectious keratitis
timeFrame: 6 months from enrollment
Secondary outcomes:
measure: Number of acute surgical interventions required.
timeFrame: 6 months from enrollment
measure: Visual acuity outcome of management.
timeFrame: 6 months from enrollment
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Shandong Eye Institute
city: Xiamen
country: China
facility: Xiamen Eye Center
city: Hyderabad
country: India
facility: L.V.Prasad Eye Institute
state: Andhra Pradesh
city: Madurai
country: India
facility: Aravind Eye Hospital
state: Tamil Nadu
city: Osaka
country: Japan
facility: Department of Ophthalmology, Faculty of Medicine, Osaka University Graduate School of Medicine Hospital
city: Tottori
country: Japan
facility: Department of Ophthalmology, Tottori University Hospital
city: Seoul
country: Korea, Republic of
facility: Department of Opthalmology & Visual Science, The Catholic University of Korea, Seoul St. Mary's Eye Institute
city: Manila
country: Philippines
facility: Department of Ophthalmology and Visual Sciences, Philippine General Hospital
city: Singapore
country: Singapore
facility: Singapore Eye Research Institute
city: Taipei City
country: Taiwan
facility: Department of Opthalmology, National Taiwan University Hospital
city: Bangkok
country: Thailand
facility: Department of Ophthalmology, Faculty of Medicine, Siriraj Hospital, Mahidol University
Study officials:
affiliation: Singapore National Eye Centre, Singapore Eye Research Institute, National University Hospital
name: Donald TH Tan, FRCS(G)
role: PRINCIPAL_INVESTIGATOR
References: