This study aims to define the factors that influenced the final visual acuity and globe survival in patients withintraocular foreign bodies that we treated by pars plana vitrectomy (PPV) over a 5-year period. We reviewed the medical records of the patients and we extracted the following parameters: age, gender, wound anatomy, characteristics of the foreign bodies, ocular lesions, initial and final visual acuities.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015040418966N3
Registration date:2015-04-09, 1394/01/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-09, 1394/01/20
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
No material or monetary support was received for this 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
Removal of Intraocular Foreign Bodies by Pars Plana Vitrectomy - Outcomes and Prognostic Factors
Public title
The removal of the foreign bodies from the eye by surgical methods
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all the patients in which pars plana vitrectomy was performed in order to extract intraocular foreign bodies.
Exclusion criteria: patients that failed the control visit.
Age
From 18 years old to 85 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
The associated lesions produced by the intraocular foreign bodies are analyzed.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee of the "Iuliu Hatieganu" University of Medicine and Pharmacy
Street address
8, V. Babes str.
City
Cluj-Napoca
Postal code
Approval date
2014-01-20, 1392/10/30
Ethics committee reference number
15
Health conditions studied
1
Description of health condition studied
Intraocular Foreign Bodies
ICD-10 code
VII
ICD-10 code description
H.44.6
Primary outcomes
1
Description
Visual acuity (vision)
Timepoint
6 months after treatment
Method of measurement
Visual acuity test with Snellen chart
Secondary outcomes
1
Description
Appearance of the eye
Timepoint
6 months after treatment
Method of measurement
Biomicroscopy of the anterior and posterior segments of the eye
Intervention groups
1
Description
We had no control group
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Ophthalmology, "Iuliu Hatieganu" University of Medicine and Pharmacy
Full name of responsible person
Street address
City
Cluj-Napoca
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Simona Delia NIcoara
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
Investigator
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
Iuliu Hatieganu University of Medicine and Pharmacy
Full name of responsible person
Simona Delia Nicoara
Position
Assoc. Professor
Other areas of specialty/work
Street address
8, V. Babes str.
City
Cluj-Napoca
Province
Cluj
Postal code
Phone
0040264596585
Fax
Email
simoananicoara1@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iuliu Hatieganu University of Medicine and Pharmacy
Full name of responsible person
Simona Delia Nicoara
Position
Assoc. Prof.
Other areas of specialty/work
Street address
8, V. Babes str.
City
Cluj-Napoca
Province
Cluj
Postal code
Phone
0040264547681
Fax
Email
stalu@umfcluj.ro
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iuliu Hatieganu University of Medicine and Pharmacy
Full name of responsible person
Simona Delia Nicoara
Position
Assoc. Prof.
Other areas of specialty/work
Street address
8, V. Babes str.
City
Cluj-Napoca
Province
Cluj
Postal code
Phone
0040264592771
Fax
Email
stalu@umfcluj.ro
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)