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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01255306
Recruitment Status : Completed
First Posted : December 7, 2010
Results First Posted : January 24, 2012
Last Update Posted : March 23, 2012
Information provided by (Responsible Party):
Mia Zoric Geber, University Hospital "Sestre Milosrdnice"

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

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
NO IOP Patients without raised IOP
RAISED IOP Patients with raised IOP

Participant Flow:   Overall Study
STARTED   26   33 
COMPLETED   25   32 
Physician Decision                1                1 

  Baseline Characteristics

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.
No text entered.

Reporting Groups
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 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   11   25   36 
>=65 years   15   8   23 
[Units: Years]
Mean (Standard Deviation)
 63.80  (12.97)   58.21  (12.26)   60.67  (12.77) 
[Units: Participants]
Female   16   11   27 
Male   10   22   32 
Region of Enrollment 
[Units: Participants]
Croatia   26   33   59 

  Outcome Measures

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

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
No text entered.

  More Information

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


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

Responsible Party: Mia Zoric Geber, University Hospital "Sestre Milosrdnice" Identifier: NCT01255306     History of Changes
Other Study ID Numbers: KBSM-30-1/10
First Submitted: December 6, 2010
First Posted: December 7, 2010
Results First Submitted: December 18, 2011
Results First Posted: January 24, 2012
Last Update Posted: March 23, 2012