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

December 6, 2010
March 22, 2012
April 2010
November 2011   (final data collection date for primary outcome measure)
Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01255306 on ClinicalTrials.gov Archive Site
Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
To assess whether retinal nerve fiber layer thickness changes in patients with raised intraocular pressure secondary to silicone oil endotamponade.
Same as current
Not Provided
Not Provided
 
The Influence of Silicone Oil on Nerve Fiber Layer Thickness After Pars Plana Vitrectomy
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

tertiary care clinic

  • Rhegmatogenous Retinal Detachment
  • Toxic Effect of Silicone
  • Glaucoma Due to Silicon Oil
  • Other: Optical coherence tomography

    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 Name: Cirrus HD OCT ( Carl Zeiss Meditec, Dublin, CA )
  • Drug: Local medical treatment of raised intraocular pressure

    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
  • NO IOP
    Patients without raised IOP
    Intervention: Other: Optical coherence tomography
  • RAISED IOP
    Patients with raised IOP
    Interventions:
    • Other: Optical coherence tomography
    • Drug: Local medical treatment of raised intraocular pressure

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Croatia
 
NCT01255306
KBSM-30-1/10
Yes
Mia Zoric Geber, University Hospital "Sestre milosrdnice"
University Hospital "Sestre milosrdnice"
Not Provided
Principal Investigator: Mia Zoric Geber, MD University department of Ophthalmology, University Hospital "Sestre milosrdnice"
University Hospital "Sestre milosrdnice"
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP