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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
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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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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 
Overall Participants Analyzed 
[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 ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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