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Trial registered on ANZCTR


Registration number
ACTRN12614000089639
Ethics application status
Approved
Date submitted
11/01/2014
Date registered
23/01/2014
Date last updated
23/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of Surgical Results of 23-gauge Vitrectomy and Silicone Oil Tamponade Combined with and without Phacoemulsification
Scientific title
Safety and efficacy of 23-gauge vitrectomy and silicone oil tamponade combined with and without phacoemulsification in patients undergoing vitreoretinal surgery.
Secondary ID [1] 283892 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
rhegmatogenous retinal detachment 290877 0
proliferative diabetic retinopathy 290980 0
vitreous hemorrhage 290981 0
Condition category
Condition code
Eye 291236 291236 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
23-gauge vitrectomy and silicone oil tamponade combined with phacoemulsification were allocated to the group 1.

Trans-scleral cannulas were placed through the pars plana in the superonasal, superotemporal, and inferotemporal quadrants, per standard vitrectomy protocol. In the combined group, phacoemulsification and IOL implantation was performed before PPV through a 2.75 mm superior clear corneal incision. Hydrophilic acrylic IOL inserted to the capsular bag in all cases. All eyes underwent core vitrectomy followed by removal of the posterior hyaloid membrane and vitreous traction. Retinal photocoagulation was performed in selected eyes. The fluid in the vitreous cavity was exchanged with silicone oil after vitrectomy. The approximate duration of procedure is 90 minutes.
Intervention code [1] 288567 0
Treatment: Surgery
Comparator / control treatment
23-gauge vitrectomy and silicone oil tamponade alone were allocated to the group 2.

Trans-scleral cannulas were placed through the pars plana in the superonasal, superotemporal, and inferotemporal quadrants, per standard vitrectomy protocol. All eyes underwent core vitrectomy followed by removal of the posterior hyaloid membrane and vitreous traction. Retinal photocoagulation was performed in selected eyes. The fluid in the vitreous cavity was exchanged with silicone oil after vitrectomy. The approximate duration of procedure is 70 minutes.
Control group
Active

Outcomes
Primary outcome [1] 291233 0
The clinical outcomes of 23-gauge vitrectomy and silicone oil tamponade were evaluated. A complete ophthalmologic examination was performed including best corrected visual acuity (BCVA) with the Snellen chart, intraocular pressure (IOP) with applanation tonometry, slit-lamp biomicroscopy, and dilated fundus examination.
Timepoint [1] 291233 0
two year
Secondary outcome [1] 306300 0
Recurrent retinal detachments rate between two groups.

Snellen chart, applanation tonometry, slit-lamp biomicroscopy, and dilated fundus examination.
Timepoint [1] 306300 0
two year

Eligibility
Key inclusion criteria
The patients that underwent 23-gauge vitrectomy and silicone oil tamponade combined with and without phacoemulsification with following conditions included the study; rhegmatogenous retinal detachment, proliferative diabetic retinopathy with tractional retinal detachment, proliferative diabetic retinopathy with nonclearing vitreous hemorrhage, central retinal vein occlusion with vitreous hemorrhage and idiopathic epiretinal membrane.
Minimum age
38 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a history of prior vitreoretinal surgery and any corneal pathology were excluded from the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Nineteen eyes of 19 cases that underwent 23-gauge vitrectomy and silicone oil tamponade combined with phacoemulsification were allocated to the group 1, and 19 eyes of 19 cases that underwent 23-gauge vitrectomy and silicone oil tamponade alone were allocated to the group 2. Surgery was performed for the following retinal conditions: rhegmatogenous retinal detachment, proliferative diabetic retinopathy with tractional retinal detachment, proliferative diabetic retinopathy with nonclearing vitreous hemorrhage, central retinal vein occlusion with vitreous hemorrhage and idiopathic epiretinal membrane.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nonrandomised trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All statistics in this study were analyzed using SPSS for Windows (SPSS Inc., Chicago, IL, USA). Preoperative numerical data of the first groups were compared with the Mann Whitney U test which of the difference between the distributions of data collected in two experimental conditions applied to unmatched groups of subjects but comparing the distributions of the ranks of the scores.

In order to do the inferential analyses of three times studied between themselves it was used the Friedman test. This test was complemented by the Wilcoxon signed rank test to cases in which there were significant statistical difference pointed by the Friedman test. Bonferonni corrected, was used to perform pairwise comparisons (in the text, p-values are corrected). Visual acuity was measured with the Snellen chart, then converted to the logMAR chart and mean best-corrected visual acuities were calculated. Finally, LogMAR scores were converted back to snellen. The level of significance was set at <0.05.

To determine the sample size we need to specify, a form of a priori power analysis is used. G Power 3 is used for calculating statistical power. The graph was generated from G Power on power analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/01/2009
Actual
9/01/2009
Date of last participant enrolment
Anticipated
30/12/2011
Actual
30/12/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
38
Accrual to date
Final
Recruitment outside Australia
Country [1] 5744 0
Turkey
State/province [1] 5744 0
Ankara

Funding & Sponsors
Funding source category [1] 288534 0
Self funded/Unfunded
Name [1] 288534 0
none
Country [1] 288534 0
Primary sponsor type
Hospital
Name
SB Ankara Ulucanlar Eye Education and Research Hospital, Ankara, Turkey
Address
ULUCANLAR CAD. NO:59 06230 ALTINDAG/ANKARA
Country
Turkey
Secondary sponsor category [1] 287245 0
None
Name [1] 287245 0
Address [1] 287245 0
Country [1] 287245 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290401 0
Diskapi training and research hospital
Ethics committee address [1] 290401 0
Ethics committee country [1] 290401 0
Turkey
Date submitted for ethics approval [1] 290401 0
01/01/2009
Approval date [1] 290401 0
05/01/2009
Ethics approval number [1] 290401 0
06

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45482 0
A/Prof Mehmet CITIRIK
Address 45482 0
SB Ankara Ulucanlar Eye Education and Research Hospital, Ankara, Turkey

Fakulteler Mah. Yazgan Sk. No: 34/12 06590 Cebeci/ANKARA/TURKEY
Country 45482 0
Turkey
Phone 45482 0
90-312-3126261
Fax 45482 0
90-312-3124827
Email 45482 0
[email protected]
Contact person for public queries
Name 45483 0
Mehmet CITIRIK
Address 45483 0
SB Ankara Ulucanlar Eye Education and Research Hospital, Ankara, Turkey

Fakulteler Mah. Yazgan Sk. No: 34/12 06590 Cebeci/ANKARA/TURKEY
Country 45483 0
Turkey
Phone 45483 0
90-312-3126261
Fax 45483 0
90-312-3124827
Email 45483 0
[email protected]
Contact person for scientific queries
Name 45484 0
Mehmet CITIRIK
Address 45484 0
SB Ankara Ulucanlar Eye Education and Research Hospital, Ankara, Turkey

Fakulteler Mah. Yazgan Sk. No: 34/12 06590 Cebeci/ANKARA/TURKEY
Country 45484 0
Turkey
Phone 45484 0
90-312-3126261
Fax 45484 0
90-312-3124827
Email 45484 0
[email protected]

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

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