The study presents the experience of the Ophthalmology Department from Cluj-Napoca (Romania) in treating posttraumatic endophthalmitis, expressed by the recovery of the visual acuity
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014082918966N1
Registration date:2014-09-05, 1393/06/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-05, 1393/06/14
Registrant information
Name
Simona Delia Nicoara
Name of organization / entity
Iuliu Hatieganu University of Medicine
Country
Romania
Phone
0040264597256
Email address
stalu@umfcluj.ro
Recruitment status
Recruitment complete
Funding source
We received no monetary or material support for the study
Expected recruitment start date
2009-01-01, 1387/10/12
Expected recruitment end date
2013-12-31, 1392/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Outcome and prognostic factors for traumatic endophthalmitis over a 5-year period
Public title
Visual recovery after the intraocular infections following eye trauma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all the consecutive cases with the clinical diagnosis of traumatic endophthalmitis
Exclusion criteria: none
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
14
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the "Iuliu Hatieganu" University of Medicine and Pharmacy
Street address
8, V. Babes str.
City
Cluj-Napoca
Postal code
Approval date
2014-02-20, 1392/12/01
Ethics committee reference number
19
Health conditions studied
1
Description of health condition studied
Posttraumatic endophthalmitis
ICD-10 code
H.44.0
ICD-10 code description
Primary outcomes
1
Description
Visual acuity
Timepoint
Six months after treatment
Method of measurement
Measurement of the visual acuity
Secondary outcomes
1
Description
Anatomical integrity of the eye
Timepoint
One month after treatment
Method of measurement
Slit lamp examination of the eye
Intervention groups
1
Description
Intervention consisted in parts plana vitrectomy (removal of the vitreous body) completed with the intraocular injection of antibiotics (vancomycin 1 mg/0.01 ml and ceftazidim 2.2 mg/0.01 ml) and steroids (dexamethasone 0.4 mg/0.1 ml)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Ophthalmology,
Full name of responsible person
Neagoe Ioana
Street address
8, V. Babes str.
City
Cluj-Napoca
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nicoara Simona Delia
Full name of responsible person
Cristian Cristina
Street address
8, V. Babes str.
City
Cluj-Napoca
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nicoara Simona Delia
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Full name of responsible person
Nicoara Simona Delia
Position
Assoc. Prof
Other areas of specialty/work
Street address
8, V. Babes str.
City
Cluj-Napoca
Province
Cluj
Postal code
400012
Phone
0040264597256
Fax
Email
simonanicoara1@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Full name of responsible person
Irimescu Iulian
Position
MD
Other areas of specialty/work
Street address
8, V. Babes str.
City
Cluj-Napoca
Province
Cluj
Postal code
400012
Phone
0040264597256
Fax
Email
iulirimes@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Cristian Cristina
Position
MD
Other areas of specialty/work
Street address
8, V. Babes str.
City
Cluj-Napoca
Province
Cluj
Postal code
400012
Phone
0040264597256
Fax
Email
christinacristian@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)