The Influence of Silicone Oil on Nerve Fiber Layer Thickness After Pars Plana Vitrectomy
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| Tracking Information | |||||
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| First Received Date ICMJE | December 6, 2010 | ||||
| Last Updated Date | March 22, 2012 | ||||
| Start Date ICMJE | April 2010 | ||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Evidence of Retinal Nerve Fibre Layer Thickness Change Measured by Optical Coherence Tomography [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01255306 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Retinal Nerve Fiber Layer Thickness Change in Patients With Raised Intraocular Pressure Secondary to Silicone Oil Endotamponade [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] To assess whether retinal nerve fiber layer thickness changes in patients with raised intraocular pressure secondary to silicone oil endotamponade. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Influence of Silicone Oil on Nerve Fiber Layer Thickness After Pars Plana Vitrectomy | ||||
| Official Title ICMJE | The Influence of Silicone Oil on Nerve Fiber Layer Thickness After Pars Plana Vitrectomy | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | tertiary care clinic |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Group/Cohort (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 60 | ||||
| Completion Date | December 2011 | ||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: - patients with rhegmatogenous retinal detachment Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Croatia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01255306 | ||||
| Other Study ID Numbers ICMJE | KBSM-30-1/10 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Mia Zoric Geber, University Hospital "Sestre milosrdnice" | ||||
| Study Sponsor ICMJE | University Hospital "Sestre milosrdnice" | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital "Sestre milosrdnice" | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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