The Asia Cornea Society Infectious Keratitis Study (ACSIKS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Asia Cornea Society
Sponsor:
Collaborator:
Singapore Clinical Research Institute
Information provided by (Responsible Party):
Prof Donald TH Tan, Asia Cornea Society
ClinicalTrials.gov Identifier:
NCT01560208
First received: March 20, 2012
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

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.


Condition
Corneal Ulcer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Asia Cornea Society Infectious Keratitis Study

Resource links provided by NLM:


Further study details as provided by Asia Cornea Society:

Primary Outcome Measures:
  • Resolution of infectious keratitis [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
    Resolution of the infectious keratitis occurs when the infiltrate clears, epithelium heals over, and inflammation subsides.


Secondary Outcome Measures:
  • Number of acute surgical interventions required. [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
    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.

  • Visual acuity outcome of management. [ Time Frame: 6 months from enrollment ] [ Designated as safety issue: No ]
    Visual acuity will be documented. Reasons for poor visual acuity (less than 6/18 or 0.3) will be recorded.


Biospecimen Retention:   Samples Without DNA

Positive bacterial and fungal growth obtained from the cornea samples of ACSIKS patients will be retained and stored.


Estimated Enrollment: 6750
Study Start Date: April 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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").

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560208

Locations
China
Shandong Eye Institute Recruiting
Qingdao, China, 266071
Contact: Lixin Xie, MD       lixin_xie@yahoo.com   
Principal Investigator: Lixin Xie         
Xiamen Eye Center Recruiting
Xiamen, China
Contact: Li Wei       wei1018@gmail.com   
Principal Investigator: Zuguo Liu         
India
L.V.Prasad Eye Institute Recruiting
Hyderabad, Andhra Pradesh, India, 500 034
Contact: Prashant Garg       prashant@lvpei.org   
Principal Investigator: Prashant Garg         
Aravind Eye Hospital Recruiting
Madurai, Tamil Nadu, India, 625 020
Contact: Sean D'Silva       sean.socrates@gmail.com   
Principal Investigator: Venkatesh Prajna         
Japan
Department of Ophthalmology, Faculty of Medicine, Osaka University Graduate School of Medicine Hospital Recruiting
Osaka, Japan, 565-0871
Contact: Takeshi Soma       soma@ophthal.med.osaka-u.ac.jp   
Principal Investigator: Kohji Nishida         
Department of Ophthalmology, Tottori University Hospital Recruiting
Tottori, Japan, 683-8504
Contact: Chizu Touge       chizuchizu116@yahoo.co.jp   
Principal Investigator: Yoshitsugu Inoue         
Korea, Republic of
Department of Opthalmology & Visual Science, The Catholic University of Korea, Seoul St. Mary's Eye Institute Recruiting
Seoul, Korea, Republic of, 137-701
Contact: Choun-Ki Joo       ckjoo@catholic.ac.kr   
Principal Investigator: Choun-Ki Joo         
Philippines
Department of Ophthalmology and Visual Sciences, Philippine General Hospital Recruiting
Manila, Philippines, 1223
Contact: Denise Mae Palmos       denicepalmos@gmail.com   
Principal Investigator: Ma Dominga B Padilla         
Singapore
Singapore Eye Research Institute Recruiting
Singapore, Singapore, 168751
Contact: Abriena Xie       abriena.xie.e.j@seri.com.sg   
Principal Investigator: Jodhbir Mehta         
Taiwan
Department of Opthalmology, National Taiwan University Hospital Recruiting
Taipei City, Taiwan, 100
Contact: Stephanie Chu       einahpets18@gmail.com   
Principal Investigator: Fung Rong Hu         
Thailand
Department of Ophthalmology, Faculty of Medicine, Siriraj Hospital, Mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: Pormsiri Chinawangwatarnakrnl       srpea@mahidol.ac.th   
Principal Investigator: Panida Goseyarakwong         
Sponsors and Collaborators
Asia Cornea Society
Singapore Clinical Research Institute
Investigators
Principal Investigator: Donald TH Tan, FRCS(G) Singapore National Eye Centre, Singapore Eye Research Institute, National University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Prof Donald TH Tan, Principal Investigator and Chairman, ACSIKS Council, Asia Cornea Society
ClinicalTrials.gov Identifier: NCT01560208     History of Changes
Other Study ID Numbers: ACSIKS
Study First Received: March 20, 2012
Last Updated: December 18, 2012
Health Authority: Singapore: Ministry of Health

Keywords provided by Asia Cornea Society:
infectious keratitis
infective keratitis
prospective multicentre study
Asia

Additional relevant MeSH terms:
Communicable Diseases
Infection
Corneal Ulcer
Keratitis
Ulcer
Eye Infections
Corneal Diseases
Eye Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014