Corneal UlcerACSIKSNCT01560208
The Asia Cornea Society Infectious Keratitis Study
An observational study of Corneal Ulcer, run by Asia Cornea Society at 11 sites in 8 countries.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Corneal Ulcer
- How many people
- 6,750 participants
- Where
- 11 sitesin 8 countries
- Study dates
- Apr 2012to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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").
Who may be able to join
- all patients presenting to an ACSIKS site during the study period with an initial diagnosis of infectious keratitis in one or both eyes
Who cannot join
- patients who are cognitively impaired or otherwise unable to give direct informed consent
Trial locations and contacts
11 sites in 8 countries.
11 sites in 8 countries
China2 sites, 2 recruiting
- Recruiting
Shandong Eye Institute
Qingdao, 266071
Lixin Xie, MD, lixin_xie@yahoo.com
Lixin Xie
- Recruiting
Xiamen Eye Center
Xiamen
Li Wei, wei1018@gmail.com
Zuguo Liu
India2 sites, 2 recruiting
- Recruiting
L.V.Prasad Eye Institute
Hyderabad, Andhra Pradesh, 500 034
Prashant Garg, prashant@lvpei.org
Prashant Garg
- Recruiting
Aravind Eye Hospital
Madurai, Tamil Nadu, 625 020
Sean D'Silva, sean.socrates@gmail.com
Venkatesh Prajna
Japan2 sites, 2 recruiting
- Recruiting
Department of Ophthalmology, Faculty of Medicine, Osaka University Graduate School of Medicine Hospital
Osaka, 565-0871
Takeshi Soma, soma@ophthal.med.osaka-u.ac.jp
Kohji Nishida
- Recruiting
Department of Ophthalmology, Tottori University Hospital
Tottori, 683-8504
Chizu Touge, chizuchizu116@yahoo.co.jp
Yoshitsugu Inoue
Philippines1 site, 1 recruiting
- Recruiting
Department of Ophthalmology and Visual Sciences, Philippine General Hospital
Manila, 1223
Denise Mae Palmos, denicepalmos@gmail.com
Ma Dominga B Padilla
Singapore1 site, 1 recruiting
- Recruiting
Singapore Eye Research Institute
Singapore, 168751
Abriena Xie, abriena.xie.e.j@seri.com.sg
Jodhbir Mehta
South Korea1 site, 1 recruiting
- Recruiting
Department of Opthalmology & Visual Science, The Catholic University of Korea, Seoul St. Mary's Eye Institute
Seoul, 137-701
Choun-Ki Joo, ckjoo@catholic.ac.kr
Choun-Ki Joo
Taiwan1 site, 1 recruiting
- Recruiting
Department of Opthalmology, National Taiwan University Hospital
Taipei, 100
Stephanie Chu, einahpets18@gmail.com
Fung Rong Hu
Thailand1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, 10700
Pormsiri Chinawangwatarnakrnl, srpea@mahidol.ac.th
Panida Goseyarakwong
About this study
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.
Read the 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.
- Conditions
- Corneal Ulcer
- Keywords
- infectious keratitis, infective keratitis, prospective multicentre study, Asia
- Medical subject headings
- Corneal Ulcer
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of infectious keratitis
Resolution of the infectious keratitis occurs when the infiltrate clears, epithelium heals over, and inflammation subsides.
Measured: 6 months from enrollment
Secondary outcomes (2)
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.
Measured: 6 months from enrollment
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.
Measured: 6 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 6,750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asia Cornea Society
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore Clinical Research Institute
- Responsible party
- Principal investigator, Prof Donald TH Tan, Asia Cornea Society
- Investigators
- Donald TH Tan, FRCS(G), Principal investigator, Singapore National Eye Centre, Singapore Eye Research Institute, National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560208
- Sponsor's protocol ID
- ACSIKS
- Acronym
- ACSIKS
- Status last verified
- Dec 2012
- First submitted
- 20 Mar 2012
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Asia Cornea Society Infectious Keratitis Study
- ClinicalTrials.gov ID
- NCT01560208
- Acronym / sponsor ID
- ACSIKS / ACSIKS
- Conditions
- Corneal Ulcer
- Keywords
- infectious keratitis, infective keratitis, prospective multicentre study, Asia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,750 participants (estimated)
- Lead sponsor
- Asia Cornea SocietyUniversity, hospital or other
- Collaborators
- Singapore Clinical Research Institute
- Study start
- Apr 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 22 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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").
Key inclusion criteria (1 listed)
- all patients presenting to an ACSIKS site during the study period with an initial diagnosis of infectious keratitis in one or both eyes
Key exclusion criteria (1 listed)
- patients who are cognitively impaired or otherwise unable to give direct informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Number of acute surgical interventions required.
Time frame: 6 months from enrollment
Visual acuity outcome of management.
Time frame: 6 months from enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
Related trials for Corneal Ulcer
Not yet recruiting
A Single-Center Clinical Study Evaluating the Efficacy and Safety of Allogeneic Natural Killer (NK) Cell Transplantation for Mooren's Ulcer
Cornea Disease
RecruitingPhase 2
Efficacy of Locally Delivered Allogeneic Mesenchymal Stromal Cells
Corneal Ulcer
RecruitingPhase 3
Parasitic Ulcer Treatment Trial
Acanthamoeba Keratitis
Recruiting
Intrastromal Moxifloxacin as an Adjunctive Therapy in Recalcitrant Bacterial Keratitis
Bacterial Keratitis, Recalcitrant Infectious Keratitis
Not yet recruitingPhase 2
Fluorometholone Study
Keratitis Bacterial, Corneal Ulcer (Diagnosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald TH Tan, FRCS(G) principal investigator
Singapore National Eye Centre, Singapore Eye Research Institute, National University Hospital
11 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Ulcer, run by Asia Cornea Society at 11 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China, India, Japan, Philippines, Singapore and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of infectious keratitis (time frame: 6 months from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2012.