Clinical trial NCT01255306: The Influence of Silicone Oil on Nerve Fiber Layer Thickness After Pars Plana Vitrectomy
Official title: The Influence of Silicone Oil on Nerve Fiber Layer Thickness After Pars Plana Vitrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhegmatogenous Retinal Detachment
Toxic Effect of Silicone
Glaucoma Due to Silicon Oil
Keywords: Rhegmatogenous retinal detachment
Pars plana vitrectomy
Silicone oil
Retinal nerve fibre layer
Lead sponsor: University Hospital Sestre Milosrdnice
Sponsor class: OTHER
First posted: 2010-12-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: tertiary care clinic

Brief summary: 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.

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 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

Primary outcomes:
measure: Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography
timeFrame: 6 months
Secondary outcomes:
measure: Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade
timeFrame: 6 months
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Department of Ophthalmology, University Hospital "Sestre milosrdnice", Vinogradska 29
Study officials:
affiliation: University department of Ophthalmology, University Hospital "Sestre milosrdnice"
name: Mia Zoric Geber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Honavar SG, Goyal M, Majji AB, Sen PK, Naduvilath T, Dandona L. Glaucoma after pars plana vitrectomy and silicone oil injection for complicated retinal detachments. Ophthalmology. 1999 Jan;106(1):169-76; discussion 177. doi: 10.1016/S0161-6420(99)90017-9.
citation: Al-Jazzaf AM, Netland PA, Charles S. Incidence and management of elevated intraocular pressure after silicone oil injection. J Glaucoma. 2005 Feb;14(1):40-6. doi: 10.1097/01.ijg.0000145811.62095.fa.
citation: Mastropasqua L, Carpineto P, Ciancaglini M, Falconio G, Harris A. Reproducibility of nerve fiber layer thickness measurements using optical coherence tomography in silicone oil-filled eyes. Ophthalmologica. 2001 Mar-Apr;215(2):91-6. doi: 10.1159/000050836.
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citation: Kee C, Cho C. Evaluation of retinal nerve fiber layer thickness in the area of apparently normal hemifield in glaucomatous eyes with optical coherence tomography. J Glaucoma. 2003 Jun;12(3):250-4. doi: 10.1097/00061198-200306000-00012.
citation: Wollstein G, Schuman JS, Price LL, Aydin A, Beaton SA, Stark PC, Fujimoto JG, Ishikawa H. Optical coherence tomography (OCT) macular and peripapillary retinal nerve fiber layer measurements and automated visual fields. Am J Ophthalmol. 2004 Aug;138(2):218-25. doi: 10.1016/j.ajo.2004.03.019.
citation: Shah NN, Bowd C, Medeiros FA, Weinreb RN, Sample PA, Hoffmann EM, Zangwill LM. Combining structural and functional testing for detection of glaucoma. Ophthalmology. 2006 Sep;113(9):1593-602. doi: 10.1016/j.ophtha.2006.06.004.
citation: Yalvac IS, Altunsoy M, Cansever S, Satana B, Eksioglu U, Duman S. The correlation between visual field defects and focal nerve fiber layer thickness measured with optical coherence tomography in the evaluation of glaucoma. J Glaucoma. 2009 Jan;18(1):53-61. doi: 10.1097/IJG.0b013e318179f751.
citation: Inoue M, Iriyama A, Kadonosono K, Tamaki Y, Yanagi Y. Effects of perfluorocarbon liquids and silicone oil on human retinal pigment epithelial cells and retinal ganglion cells. Retina. 2009 May;29(5):677-81. doi: 10.1097/IAE.0b013e318196fca1.
citation: Zoric Geber M, Bencic G, Vatavuk Z, Ivekovic R, Friberg TR. Retinal nerve fibre layer thickness measurements after successful retinal detachment repair with silicone oil endotamponade. Br J Ophthalmol. 2015 Jun;99(6):853-8. doi: 10.1136/bjophthalmol-2014-305839. Epub 2014 Dec 15.