The Asia Cornea Society Infectious Keratitis Study

NCT01560208 | Unknown

• 1 other identifier: ACSIKS
• Study Type: observational
• Target: 6,750
• Locations: 8 countries
• Sites: 11

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.

Conditions

Corneal Ulcer

Keywords

infectious keratitis; infective keratitis; prospective multicentre study; Asia

Outcome Measures

Primary Outcomes (1)

• Resolution of infectious keratitis

  Resolution of the infectious keratitis occurs when the infiltrate clears, epithelium heals over, and inflammation subsides.

  6 months from enrollment

Secondary Outcomes (2)

• Number of acute surgical interventions required.

  6 months from enrollment

• Visual acuity outcome of management.

  6 months from enrollment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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").

You may qualify if:

• all patients presenting to an ACSIKS site during the study period with an initial diagnosis of infectious keratitis in one or both eyes

You may not qualify if:

• patients who are cognitively impaired or otherwise unable to give direct informed consent

Sponsors & Collaborators

• Asia Cornea Society: lead
• Singapore Clinical Research Institute: collaborator

Study Sites (11)

Shandong Eye Institute

Qingdao, 266071, China

RECRUITING

Xiamen Eye Center

Xiamen, China

RECRUITING

L.V.Prasad Eye Institute

Hyderabad, Andhra Pradesh, 500 034, India

RECRUITING

Aravind Eye Hospital

Madurai, Tamil Nadu, 625 020, India

RECRUITING

Department of Ophthalmology, Faculty of Medicine, Osaka University Graduate School of Medicine Hospital

Osaka, 565-0871, Japan

RECRUITING

Department of Ophthalmology, Tottori University Hospital

Tottori, 683-8504, Japan

RECRUITING

Department of Ophthalmology and Visual Sciences, Philippine General Hospital

Manila, 1223, Philippines

RECRUITING

Singapore Eye Research Institute

Singapore, 168751, Singapore

RECRUITING

Department of Opthalmology & Visual Science, The Catholic University of Korea, Seoul St. Mary's Eye Institute

Seoul, 137-701, South Korea

RECRUITING

Department of Opthalmology, National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Department of Ophthalmology, Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Corneal Ulcer

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Keratitis; Corneal Diseases; Eye Diseases

Study Officials

• Donald TH Tan, FRCS(G)

  Singapore National Eye Centre, Singapore Eye Research Institute, National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Chairman, ACSIKS Council

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 22, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 20, 2012

Record last verified: 2012-12

Locations

CN (2); IN (2); SG (1); JP (2); KR (1); TH (1); PH (1); TW (1)