The Asia Cornea Society Infectious Keratitis Study (ACSIKS)

December 18, 2012 updated by: Prof Donald TH Tan, Asia Cornea Society

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

6750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Qingdao, China, 266071
        • Recruiting
        • Shandong Eye Institute
        • Contact:
        • Principal Investigator:
          • Lixin Xie
      • Xiamen, China
        • Recruiting
        • Xiamen Eye Center
        • Contact:
        • Principal Investigator:
          • Zuguo Liu
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500 034
        • Recruiting
        • L.V.Prasad Eye Institute
        • Contact:
        • Principal Investigator:
          • Prashant Garg
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625 020
        • Recruiting
        • Aravind Eye Hospital
        • Contact:
        • Principal Investigator:
          • Venkatesh Prajna
  • Japan
      • Osaka, Japan, 565-0871
        • Recruiting
        • Department of Ophthalmology, Faculty of Medicine, Osaka University Graduate School of Medicine Hospital
        • Contact:
        • Principal Investigator:
          • Kohji Nishida
      • Tottori, Japan, 683-8504
        • Recruiting
        • Department of Ophthalmology, Tottori University Hospital
        • Contact:
        • Principal Investigator:
          • Yoshitsugu Inoue
  • Korea, Republic of
      • Seoul, Korea, Republic of, 137-701
        • Recruiting
        • Department of Opthalmology & Visual Science, The Catholic University of Korea, Seoul St. Mary's Eye Institute
        • Contact:
        • Principal Investigator:
          • Choun-Ki Joo
  • Philippines
      • Manila, Philippines, 1223
        • Recruiting
        • Department of Ophthalmology and Visual Sciences, Philippine General Hospital
        • Contact:
        • Principal Investigator:
          • Ma Dominga B Padilla
  • Singapore
      • Singapore, Singapore, 168751
        • Recruiting
        • Singapore Eye Research Institute
        • Contact:
        • Principal Investigator:
          • Jodhbir Mehta
  • Taiwan
      • Taipei City, Taiwan, 100
        • Recruiting
        • Department of Opthalmology, National Taiwan University Hospital
        • Contact:
        • Principal Investigator:
          • Fung Rong Hu
  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Department of Ophthalmology, Faculty of Medicine, Siriraj Hospital, Mahidol University
        • Contact:
        • Principal Investigator:
          • Panida Goseyarakwong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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").

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of infectious keratitis
Time Frame: 6 months from enrollment
Resolution of the infectious keratitis occurs when the infiltrate clears, epithelium heals over, and inflammation subsides.
6 months from enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of acute surgical interventions required.
Time Frame: 6 months from enrollment
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
Visual acuity outcome of management.
Time Frame: 6 months from enrollment
Visual acuity will be documented. Reasons for poor visual acuity (less than 6/18 or 0.3) will be recorded.
6 months from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asia Cornea Society

Collaborators

Singapore Clinical Research Institute

Investigators

  • Principal Investigator: Donald TH Tan, FRCS(G), Singapore National Eye Centre, Singapore Eye Research Institute, National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

October 1, 2013

Study Registration Dates

First Submitted

March 20, 2012

First Submitted That Met QC Criteria

March 21, 2012

First Posted (Estimate)

March 22, 2012

Study Record Updates

Last Update Posted (Estimate)

December 20, 2012

Last Update Submitted That Met QC Criteria

December 18, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACSIKS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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