The Influence of Silicone Oil on Nerve Fiber Layer Thickness After Pars Plana Vitrectomy
Information source: University Hospital "Sestre milosrdnice"
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rhegmatogenous Retinal Detachment; Toxic Effect of Silicone; Glaucoma Due to Silicon Oil
Intervention: Optical coherence tomography (Other); Local medical treatment of raised intraocular pressure (Drug)
Phase: N/A
Status: Completed
Sponsored by: University Hospital "Sestre milosrdnice" Official(s) and/or principal investigator(s): Mia Zoric Geber, MD, Principal Investigator, Affiliation: University department of Ophthalmology, University Hospital "Sestre milosrdnice"
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.
Clinical Details
Official title: The Influence of Silicone Oil on Nerve Fiber Layer Thickness After Pars Plana Vitrectomy
Study design: Observational Model: Case Control, Time Perspective: Prospective
Primary outcome: Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography
Secondary outcome: Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade
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
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
University Department of Ophthalmology, University Hospital "Sestre milosrdnice", Vinogradska 29, Zagreb 10000, Croatia
Additional Information
Related publications: 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. 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. 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. Leung CK, Cheung CY, Weinreb RN, Qiu Q, Liu S, Li H, Xu G, Fan N, Huang L, Pang CP, Lam DS. Retinal nerve fiber layer imaging with spectral-domain optical coherence tomography: a variability and diagnostic performance study. Ophthalmology. 2009 Jul;116(7):1257-63, 1263.e1-2. doi: 10.1016/j.ophtha.2009.04.013. Epub 2009 May 22. 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. 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. 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. 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. 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.
Starting date: April 2010
Last updated: March 22, 2012
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