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

U

University Hospital "Sestre Milosrdnice"

Status

Completed

Conditions

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

Treatments

Drug: Local medical treatment of raised intraocular pressure
Other: Optical coherence tomography

Study type

Observational

Funder types

Other

Identifiers

NCT01255306
KBSM-30-1/10

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

NO IOP
Description:
Patients without raised IOP
Treatment:
Other: Optical coherence tomography
RAISED IOP
Description:
Patients with raised IOP
Treatment:
Other: Optical coherence tomography
Drug: Local medical treatment of raised intraocular pressure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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