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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NO IOP | Patients without raised IOP |
| |
| RAISED IOP | Patients with raised IOP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical coherence tomography | Other | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade | To assess whether retinal nerve fiber layer thickness changes in patients with raised intraocular pressure secondary to silicone oil endotamponade. | 6 months |
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Inclusion Criteria:
- patients with rhegmatogenous retinal detachment
Exclusion Criteria:
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tertiary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Mia Zoric Geber, MD | University department of Ophthalmology, University Hospital "Sestre milosrdnice" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Department of Ophthalmology, University Hospital "Sestre milosrdnice", Vinogradska 29 | Zagreb | 10000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9917800 | Background | 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. | |
| 15650603 | Background | 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. |
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We excluded one patient who developed severe inflammatory reaction 5 days following pars plana vitrectomy and silicone oile tamponade from the study.
Patients with a diagnosis of retinal detachment who fulfilled enrolment criteria were included in the study. All patient were enrolled through University Department of Ophthalmology, University Hospital "Sestre milosrdnice".
The recruitment started in April 2010 and the last patient was enrolled in June 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | NO IOP | Patients without raised IOP |
| FG001 | RAISED IOP | Patients with raised IOP |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Local medical treatment of raised intraocular pressure | Drug | 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. |
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| 11244337 | Background | 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. |
| 19464061 | Background | 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. |
| 12782844 | Background | 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. |
| 15289130 | Background | 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. |
| 16949444 | Background | 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. |
| 19142136 | Background | 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. |
| 19174720 | Background | 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. |
| 25510920 | Derived | 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | NO IOP | Patients without raised IOP |
| BG001 | RAISED IOP | Patients with raised IOP |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography | 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. | We included all patients that have completed necessary follow up visits and have had optical coherence tomography measurements at all visits in the final analysis. | Posted | Mean | Standard Deviation | micrometer | 6 months | eyes | Participants |
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| Secondary | Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade | To assess whether retinal nerve fiber layer thickness changes in patients with raised intraocular pressure secondary to silicone oil endotamponade. | We included all patients who completed follow up visits and who had valid OCT measurements as defined per protocol. | Posted | Mean | Standard Deviation | micrometer | 6 months | eyes | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | STUDY EYES | Study eyes that underwent pars plana vitrectomy and silicone oil tamponade | 0 | 57 | 0 | 57 | ||
| EG001 | CONTROL EYES | Fellow eye of each patient | 0 | 57 | 0 | 57 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mia Zoric Geber, MD | University Hospital "Sestre milosrdnice" | +385 1 3787 354 | mia.zoric-geber@zg.t-com.hr |
| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |
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| >=65 years |
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| Male |
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| RNFL thickness at 90th postop. day |
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| RNFL thickness at 180th postop. day |
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| eyes |
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