Corneal Ulcer Clinical Trial
— ACSIKSOfficial title:
The Asia Cornea Society Infectious Keratitis Study
Verified date | December 2012 |
Source | Asia Cornea Society |
Contact | n/a |
Is FDA regulated | No |
Health authority | Singapore: Ministry of Health |
Study type | Observational |
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.
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 |
Observational Model: Case-Only, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
Asia Cornea Society | Singapore Clinical Research Institute |
China, India, Japan, Korea, Republic of, Philippines, Singapore, Taiwan, Thailand,
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 |
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