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The Influence of Silicone Oil on Nerve Fiber Layer Thickness After Pars Plana Vitrectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mia Zoric Geber, University Hospital "Sestre milosrdnice"
ClinicalTrials.gov Identifier:
NCT01255306
First received: December 6, 2010
Last updated: March 22, 2012
Last verified: March 2012
History of Changes
Results First Received: December 18, 2011  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Conditions: Rhegmatogenous Retinal Detachment
Toxic Effect of Silicone
Glaucoma Due to Silicon Oil
Interventions: Other: Optical coherence tomography
Drug: Local medical treatment of raised intraocular pressure

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Patients with a diagnosis of retinal detachment who fulfilled enrolment criteria were included in the study. All patient were enrolled through University Department of Ophthalmology, University Hospital "Sestre milosrdnice".

The recruitment started in April 2010 and the last patient was enrolled in June 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
We excluded one patient who developed severe inflammatory reaction 5 days following pars plana vitrectomy and silicone oile tamponade from the study.

Reporting Groups
  Description
NO IOP Patients without raised IOP
RAISED IOP Patients with raised IOP

Participant Flow:   Overall Study
    NO IOP     RAISED IOP  
STARTED     26     33  
COMPLETED     25     32  
NOT COMPLETED     1     1  
Physician Decision                 1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
NO IOP Patients without raised IOP
RAISED IOP Patients with raised IOP
Total Total of all reporting groups

Baseline Measures
    NO IOP     RAISED IOP     Total  
Number of Participants  
[units: participants]
 		  26     33     59  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     11     25     36  
>=65 years     15     8     23  
Age  
[units: years]
Mean ± Standard Deviation 		  63.80  ± 12.97     58.21  ± 12.26     60.67  ± 12.77  
Gender  
[units: participants]
 		     
Female     16     11     27  
Male     10     22     32  
Region of Enrollment  
[units: participants]
 		     
Croatia     26     33     59  



  Outcome Measures
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1.  Primary:   Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography   [ Time Frame: 6 months ]
  Show Outcome Measure 1

2.  Secondary:   Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade   [ Time Frame: 6 months ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Mia Zoric Geber, MD
Organization: University Hospital "Sestre milosrdnice"
phone: +385 1 3787 354
e-mail: mia.zoric-geber@zg.t-com.hr


Publications:


Responsible Party: Mia Zoric Geber, University Hospital "Sestre milosrdnice"
ClinicalTrials.gov Identifier: NCT01255306     History of Changes
Other Study ID Numbers: KBSM-30-1/10
Study First Received: December 6, 2010
Results First Received: December 18, 2011
Last Updated: March 22, 2012
Health Authority: Croatia: Ethics Committee