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

March 22, 2012 updated by: Mia Zoric Geber, University Hospital "Sestre Milosrdnice"
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.

Study Overview

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zagreb, Croatia, 10000
        • University Department of Ophthalmology, University Hospital "Sestre milosrdnice", Vinogradska 29

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

tertiary care clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NO IOP
Patients without raised IOP

Optical coherence tomography will be performed in all study patients following pars plans vitrectomy and silicone oil tamponade. A fellow eye of each patient will serve as a control. Each patient enrolled in a study will receive 4 measurements:

  1. On 7th postoperative day
  2. On 30th postoperative day
  3. On 90th postoperative day
  4. On 180th postoperative day
Other Names:
  • Cirrus HD OCT ( Carl Zeiss Meditec, Dublin, CA )
RAISED IOP
Patients with raised IOP

Optical coherence tomography will be performed in all study patients following pars plans vitrectomy and silicone oil tamponade. A fellow eye of each patient will serve as a control. Each patient enrolled in a study will receive 4 measurements:

  1. On 7th postoperative day
  2. On 30th postoperative day
  3. On 90th postoperative day
  4. On 180th postoperative day
Other Names:
  • Cirrus HD OCT ( Carl Zeiss Meditec, Dublin, CA )

In patients with raised intraocular pressure following medications will be employed in order to control the intraocular pressure:

Cosopt (dorzolamide hydrochloride-timolol maleate ophthalmic solution; b.i.d.) Ganfort (Bimatoprost, timolol maleate ophthalmic solution; once daily) Alphagan (Brimonidine ophthalmic solution; b.i.d.) In patients with intraocular pressure less than 27 mmHg Alphagan will be prescribed. In patients with intraocular pressure greater than 27 mmHg either Cosopt, or Ganfort will be prescribed under the discretion of treating physician. If intraocular pressure in patients treated with either Cosopt or Ganfort does not drop under 21 mmHg, Alphagan will be added.

Other Names:
  • 1. Cosopt
  • 2. Ganfort
  • 3. Alphagan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography
Time Frame: 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.
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mia Zoric Geber, MD, University department of Ophthalmology, University Hospital "Sestre milosrdnice"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

December 6, 2010

First Submitted That Met QC Criteria

December 6, 2010

First Posted (Estimate)

December 7, 2010

Study Record Updates

Last Update Posted (Estimate)

March 23, 2012

Last Update Submitted That Met QC Criteria

March 22, 2012

Last Verified

March 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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