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
  Purpose

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.


Condition Intervention
Rhegmatogenous Retinal Detachment
Toxic Effect of Silicone
Glaucoma Due to Silicon Oil
Other: Optical coherence tomography
Drug: Local medical treatment of raised intraocular pressure

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Influence of Silicone Oil on Nerve Fiber Layer Thickness After Pars Plana Vitrectomy

Resource links provided by NLM:


Further study details as provided by University Hospital "Sestre milosrdnice":

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 60
Study Start Date: April 2010
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
NO IOP
Patients without raised IOP
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 )
RAISED IOP
Patients with raised IOP
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

tertiary care clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255306

Locations
Croatia
University Department of Ophthalmology, University Hospital "Sestre milosrdnice", Vinogradska 29
Zagreb, Croatia, 10000
Sponsors and Collaborators
University Hospital "Sestre milosrdnice"
Investigators
Principal Investigator: Mia Zoric Geber, MD University department of Ophthalmology, University Hospital "Sestre milosrdnice"
  More Information

Publications:

Responsible Party: Mia Zoric Geber, Mia Zoric Geber, MD, University Hospital "Sestre milosrdnice"
ClinicalTrials.gov Identifier: NCT01255306     History of Changes
Other Study ID Numbers: KBSM-30-1/10
Study First Received: December 6, 2010
Results First Received: December 18, 2011
Last Updated: March 22, 2012
Health Authority: Croatia: Ethics Committee

Keywords provided by University Hospital "Sestre milosrdnice":
Rhegmatogenous retinal detachment
Pars plana vitrectomy
Silicone oil
Retinal nerve fibre layer

Additional relevant MeSH terms:
Glaucoma
Retinal Detachment
Ocular Hypertension
Eye Diseases
Retinal Diseases
Brimonidine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014