Intracameral voriconazole injection in the treatment of fungal endophthalmitis developed from keratitis
| ISRCTN | ISRCTN84613089 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84613089 |
| Secondary identifying numbers | YCS |
- Submission date
- 13/12/2009
- Registration date
- 06/01/2010
- Last edited
- 06/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ying-Cheng Shen
Scientific
Scientific
No. 160, Sec 3
Taichung Port Rd
Taichung
403
Taiwan
Study information
| Study design | Retrospective non-randomised non-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Intracameral voriconazole injection in the treatment of fungal endophthalmitis developed from keratitis: a retrospective non-randomised non-controlled study |
| Study objectives | Intracameral voriconazole administered may effectively treat fungal endophthalmitis located at anterior chamber. |
| Ethics approval(s) | Taichung Veterans General Hospital (VGHTC) ethics board approved in 2009 |
| Health condition(s) or problem(s) studied | Fungal endophthalmitis developed from keratitis |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Voriconazole |
| Primary outcome measure | Clinical observation, checked 1 month and 4 months after treatments |
| Secondary outcome measures | Checked 1 month and 4 months after treatments: 1. Visual acuity 2. Fungal infiltrate disappearance |
| Overall study start date | 01/01/2005 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 10 patients |
| Key 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 |
| Key exclusion criteria | 1. Bacterial infection 2. Culture negative 3. Fungal infection from other source |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
No. 160, Sec 3
Taichung
403
Taiwan
403
Taiwan
Sponsor information
Taichung Veterans General Hospital (VGHTC) (Taiwan)
Hospital/treatment centre
Hospital/treatment centre
No. 160, Sec 3
Taichung Port Road
Taichung
403
Taiwan
| Website | http://www.vghtc.gov.tw |
|---|---|
"ROR" |
https://ror.org/00e87hq62 |
Funders
Funder type
Hospital/treatment centre
Taichung Veterans General Hospital (VGHTC) (Taiwan)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
