Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000961640
Ethics application status
Approved
Date submitted
29/08/2014
Date registered
9/09/2014
Date last updated
9/09/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Visual recovery after the intraocular infections following eye trauma
Scientific title
The experience of the Ophthalmology Department from Cluj-Napoca (Romania) in treating posttraumatic endophthalmitis, expressed by the recovery of the visual acuity
Secondary ID [1] 285251 0
None
Universal Trial Number (UTN)
U1111-1161-0370
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic endophthalmitis 292893 0
Condition category
Condition code
Eye 293184 293184 0 0
Diseases / disorders of the eye
Infection 293244 293244 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a retrospective study performed on all the consecutive cases of posttraumatic endophthalmitis that were treated in the same department over a 5-year period.
Local treatment consisted in surgery (pars plana vitrectomy) associated with intraocular antibiotics (vancomycin 1 mg, ceftazidime 2.2.mg)and steroids (dexamethasone 0.4 mg). Each of the above mentioned drugs was administered just once, at the end of the surgery.
Intervention code [1] 290131 0
Not applicable
Comparator / control treatment
There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293050 0
Visual acuity was assessed using Snellen Chart.
Timepoint [1] 293050 0
Six months after treatment
Secondary outcome [1] 310242 0
Anatomical integrity of the eye was assessed by the slit lamp examination.
Timepoint [1] 310242 0
One month after treatment
Secondary outcome [2] 310326 0
The condition of the crystalline lens, evaluated by the slit lamp examination.
Timepoint [2] 310326 0
One month after treatment
Secondary outcome [3] 310327 0
The condition of the retina (retinal detachment present or not), evaluated by the biomicroscopic examination of the retina and indirect ophthalmoscopy.
Timepoint [3] 310327 0
One month after treatment.

Eligibility
Key inclusion criteria
Patients with posttraumatic endophthalmitis
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
Program SPSS version 20.0.0. There were calculated frequencies for the following parameters: age, gender, the association or not of an intraocular foreign body, wound anatomy, the associated ocular lesions (direct traumatic cataract, retinal detachment, ocular tissue prolapse), initial visual acuity, culture (positive or negative), the interval between the trauma and the treatment initiation, initial visual acuity. The parameter according to which the outcome was defined was the final visual acuity: less than 0.1 or greater than or equal to 0.1. In every case, we considered as final, the visual acuity tested at the last visit. Statistical analyses were used to compare treatment outcomes among the study groups. Chi-square test was used to calculate the association between the categorical variables. Value less than 0.05 was considered statistically significant. In case of unequal data distribution, the p value was given by Fisher’s Exact test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/01/2014
Actual
27/01/2014
Date of last participant enrolment
Anticipated
10/02/2014
Actual
10/02/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment outside Australia
Country [1] 6322 0
Romania
State/province [1] 6322 0
Cluj

Funding & Sponsors
Funding source category [1] 289871 0
Self funded/Unfunded
Name [1] 289871 0
Not applicable (unfunded)
Country [1] 289871 0
Primary sponsor type
Individual
Name
Nicoara Simona Delia
Address
"Iuliu Hatieganu" University of Medicine and Pharmacy, 8, V. Babes str., 400012, Cluj-Napoca, Romania
Country
Romania
Secondary sponsor category [1] 288552 0
None
Name [1] 288552 0
Not applicable
Address [1] 288552 0
Not applicable
Country [1] 288552 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291594 0
Ethics Committee of the "Iuliu Hatieganu" UNiversity of Medicine and Pharmacy
Ethics committee address [1] 291594 0
8, V. Babes str., 400012, Cluj-Napoca
Ethics committee country [1] 291594 0
Romania
Date submitted for ethics approval [1] 291594 0
20/01/2014
Approval date [1] 291594 0
20/02/2014
Ethics approval number [1] 291594 0
19

Summary
Brief summary
Intraocular infections following trauma are severe conditions touching mainly young adults and can lead to permanent visual loss. The primary outcome of this study is to outline the importance of prompt intervention in this condition, by surgery and intraocular injections of antibiotics and steroids. The study presents our experience over a 5 year period. The outcomes are evaluated according to the vision, 6 months after treatment. The gravity of the lesions produced by trauma (e.g. retinal detachment) and the delayed intervention (more than 72 houts after trauma) were associated with worse outcomes.
Trial website
Trial related presentations / publications
Not applicable
Public notes
We started the enrolment of the patients after we registered the data to the Ethics Commitee, 20/01/2014. We obtained the verbal approval of the Ethics Commitee, but the written approval is dated 20/02/2014.

Contacts
Principal investigator
Name 51066 0
A/Prof Simona Delia Nicoara
Address 51066 0
"Iuliu Hatieganu" University of Medicine and Pharmacy, 8, V. Babes str.,400012, Cluj-Napoca
Country 51066 0
Romania
Phone 51066 0
+40264592771
Fax 51066 0
Email 51066 0
simonanicoara1@gmail.com
Contact person for public queries
Name 51067 0
Dr Cristina Cristian
Address 51067 0
"Iuliu Hatieganu" University of Medicine and Pharmacy, 8, V. Babes str., 400012, Cluj-Napoca
Country 51067 0
Romania
Phone 51067 0
+40264592771
Fax 51067 0
Email 51067 0
christinacristian@gmail.com
Contact person for scientific queries
Name 51068 0
Dr Iulian Irimescu
Address 51068 0
"Iuliu Hatieganu" University of Medicine and Pharmacy, 8, V. Babes str., 400012, Cluj-Napoca
Country 51068 0
Romania
Phone 51068 0
+40264592771
Fax 51068 0
Email 51068 0
iulirimes@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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