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

Completed

• 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

• Registration Number: NCT01255306
• Lead Sponsor: University Hospital "Sestre Milosrdnice"

Brief Summary

The aim of the study is to evaluate the influence of silicone oil on thickness of the retinal nerve fiber layer by using optical coherence tomography (OCT) in patients following pars plana vitrectomy.

Detailed Description

The aim of the study is to evaluate the influence of silicone oil on thickness of the retinal nerve fiber layer by using optical coherence tomography (OCT) in patients following pars plana vitrectomy.

The study will include 60 patients with a temporary silicone oil tamponade who will be surgically treated with pars plana vitrectomy for rhegmatogenous retinal detachment and proliferative vitreoretinopathy. All subjects will be subdued to complete ophthalmologic examinations, measurements of the retinal nerve fiber layer thickness by an OCT examination, tests of the visual field with the use of an Octopus computed perimeter (automated static perimetry) and FDT-perimetry - both prior to the surgery, and on control visits for check-up during the postoperative period.

All results provided by postoperative examinations will be compared with one another.

The study is expected to provide data on the effect of the silicone oil on thickness of the retinal nerve fiber layer. It is also planned to show possibilities and advantages of OCT as a method of choice in the follow-up of patients with intraocular silicone oil tamponade.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-06
• Study First Posted: 2010-12-07
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Results First Submitted: 2011-12-18
• Results First Submitted QC: 2011-12-18
• Results First Posted: 2012-01-24
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-22
• Last Update Posted: 2012-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients with rhegmatogenous retinal detachment

Exclusion Criteria

• preexistent glaucoma
• previous retinal surgery
• placement of scleral buckle during surgery
• patients with more than 1/2 of emulsified silicone oil in anterior chamber postoperatively
• patients who develop silicone oil keratopathy postoperatively
• patients who develop silicone oil cataract which blocks visualization of posterior segment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NO IOP	Optical coherence tomography	Patients without raised IOP
RAISED IOP	Optical coherence tomography	Patients with raised IOP
RAISED IOP	Local medical treatment of raised intraocular pressure	Patients with raised IOP

Primary Outcome Measures

Name	Time	Method
Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography	6 months	Retinal nerve fiber layer thickness change measured by optical coherence tomography might be an additional parameter that could provide new insights into clinical decision making in patients with silicone oil tamponade.

Secondary Outcome Measures

Name	Time	Method
Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade	6 months	To assess whether retinal nerve fiber layer thickness changes in patients with raised intraocular pressure secondary to silicone oil endotamponade.

Trial Locations

Locations (1)

University Department of Ophthalmology, University Hospital "Sestre milosrdnice", Vinogradska 29; 🇭🇷 Zagreb, Croatia