|
ISRCTN
|
ISRCTN84613089
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Intracameral voriconazole injection in the treatment of fungal endophthalmitis developed from keratitis
|
|
Scientific title
|
Intracameral voriconazole injection in the treatment of fungal endophthalmitis developed from keratitis: a retrospective non-randomised non-controlled study
|
|
Acronym
|
N/A
|
|
Serial number at source
|
YCS
|
|
Study hypothesis
|
Intracameral voriconazole administered may effectively treat fungal endophthalmitis located at anterior chamber.
|
|
Lay summary
|
|
|
Ethics approval
|
Taichung Veterans General Hospital (VGHTC) ethics board approved in 2009
|
|
Study design
|
Retrospective non-randomised non-controlled study
|
|
Countries of recruitment
|
Taiwan
|
|
Disease/condition/study domain
|
Fungal endophthalmitis developed from keratitis
|
|
Participants - inclusion criteria
|
1. Fungal endophthalmitis from keratitis
2. Anterior chamber shows fungal web, fungal balls or endothelial plaque
3. Culture approved
4. Aged 38 - 78 years, either sex
|
|
Participants - exclusion criteria
|
1. Bacterial infection
2. Culture negative
3. Fungal infection from other source
|
|
Anticipated start date
|
01/01/2005
|
|
Anticipated end date
|
31/12/2008
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
10 patients
|
|
Interventions
|
100 μg of voriconazole in 0.1 ml was injected into the anterior chamber using a 30-gauge needle attached to a 1.0 ml regular insulin syringe. Intracameral voriconazole injection was given once a day and the treatment discontinued while the eyes showed disappearance of the endothelial plaque and resolution of the anterior chamber fungal infiltrate. Patients diagnosed with filamentous fungal keratitis progressing to endophthalmitis who had undergone treatment with intracameral voriconazole injection and were followed up for at least 4 months.
|
|
Primary outcome measure(s)
|
Clinical observation, checked 1 month and 4 months after treatments
|
|
Secondary outcome measure(s)
|
Checked 1 month and 4 months after treatments:
1. Visual acuity
2. Fungal infiltrate disappearance
|
|
Sources of funding
|
Taichung Veterans General Hospital (VGHTC) (Taiwan)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Ying-Cheng
Shen
|
|
Address
|
No. 160, Sec 3
Taichung Port Rd
|
|
City/town
|
Taichung
|
|
Zip/Postcode
|
403
|
|
Country
|
Taiwan
|
|
Sponsor
|
Taichung Veterans General Hospital (VGHTC) (Taiwan)
|
|
Address
|
No. 160, Sec 3
Taichung Port Road
|
|
City/town
|
Taichung
|
|
Zip/Postcode
|
403
|
|
Country
|
Taiwan
|
|
Sponsor website:
|
http://www.vghtc.gov.tw
|
|
Date applied
|
13/12/2009
|
|
Last edited
|
06/01/2010
|
|
Date ISRCTN assigned
|
06/01/2010
|
