The Influence of Silicone Oil on Nerve Fiber Layer Thickness After Pars Plana Vitrectomy
NCT ID: NCT01255306
Last Updated: 2012-03-23
Study Results
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View full resultsBasic Information
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COMPLETED
60 participants
OBSERVATIONAL
2010-04-30
2011-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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NO IOP
Patients without raised IOP
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
RAISED IOP
Patients with raised IOP
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
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.
Interventions
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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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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University Hospital Sestre Milosrdnice
OTHER
Responsible Party
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Mia Zoric Geber
Mia Zoric Geber, MD
Principal Investigators
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Mia Zoric Geber, MD
Role: PRINCIPAL_INVESTIGATOR
University department of Ophthalmology, University Hospital "Sestre milosrdnice"
Locations
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University Department of Ophthalmology, University Hospital "Sestre milosrdnice", Vinogradska 29
Zagreb, , Croatia
Countries
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References
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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.
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.
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.
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. doi: 10.1097/00061198-200306000-00012.
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.
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.
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.
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.
Other Identifiers
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KBSM-30-1/10
Identifier Type: -
Identifier Source: org_study_id
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