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Completed

NCT Number: NCT01255306

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

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.

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Key information

Conditions

Rhegmatogenous Retinal Detachment Glaucoma Due to Silicon Oil Toxic Effect of Silicone

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Department of Ophthalmology, University Hospital "Sestre milosrdnice", Vinogradska 29

Zagreb, 10000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

optical coherence tomography

Other

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:

  • On 7th postoperative day
  • On 30th postoperative day
  • On 90th postoperative day
  • On 180th postoperative day

Other names: Cirrus HD OCT ( Carl Zeiss Meditec, Dublin, CA )

Local medical treatment of raised intraocular pressure

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital Sestre Milosrdnice

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 7, 2010
Registry last updated
Mar 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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