Condition category
Eye Diseases
Date applied
13/12/2009
Date assigned
06/01/2010
Last edited
06/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ying-Cheng Shen

ORCID ID

Contact details

No. 160
Sec 3
Taichung Port Rd
Taichung
403
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

YCS

Study information

Scientific title

Intracameral voriconazole injection in the treatment of fungal endophthalmitis developed from keratitis: a retrospective non-randomised non-controlled study

Acronym

Study hypothesis

Intracameral voriconazole administered may effectively treat fungal endophthalmitis located at anterior chamber.

Ethics approval

Taichung Veterans General Hospital (VGHTC) ethics board approved in 2009

Study design

Retrospective non-randomised non-controlled study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Voriconazole

Primary outcome measures

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 trial start date

01/01/2005

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10 patients

Participant exclusion criteria

1. Bacterial infection
2. Culture negative
3. Fungal infection from other source

Recruitment start date

01/01/2005

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Taiwan

Trial participating centre

No. 160, Sec 3
Taichung
403
Taiwan

Sponsor information

Organisation

Taichung Veterans General Hospital (VGHTC) (Taiwan)

Sponsor details

No. 160
Sec 3
Taichung Port Road
Taichung
403
Taiwan

Sponsor type

Hospital/treatment centre

Website

http://www.vghtc.gov.tw

Funders

Funder type

Hospital/treatment centre

Funder name

Taichung Veterans General Hospital (VGHTC) (Taiwan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes