Choroidal Blood Flow and Progression of Age-Related Macular Degeneration in the Fellow Eye in Patients With Unilateral Choroidal Neovascularisation
| Tracking Information | |||||
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| First Received Date ICMJE | December 12, 2008 | ||||
| Last Updated Date | December 12, 2008 | ||||
| Start Date ICMJE | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Choroidal Blood Flow and Progression of Age-Related Macular Degeneration in the Fellow Eye in Patients With Unilateral Choroidal Neovascularisation | ||||
| Official Title ICMJE | Choroidal Blood Flow and Progression of Age-Related Macular Degeneration in the Fellow Eye in Patients With Unilateral Choroidal Neovascularisation | ||||
| Brief Summary | Age-related macular degeneration (AMD) is the chief cause of severe and irreversible loss of vision in developed countries. The prevalence of AMD increases dramatically with age. The early stage (or dry AMD) is associated with minimal visual impairment and is characterized by large drusen and pigmentary abnormalities in the macula. The late stage is a neovascular, exudative form. This so called exudative AMD includes serous or hemorrhagic detachment of retinal pigment epithelium and choroidal neovascularization leading to severe loss of vision (20/200 or worse). Patients with unilateral CNV (choroidal neovascularisation) have a significant risk of CNV developing in the second eye. Choroidal blood flow is of great importance for normal visual function. Several reports have provided evidence suggesting that choroidal blood flow is decreased in subjects with AMD. In late stages of AMD angiogenesis leads to the formation of choroidal neovascularization that can cause severe visual impairment by disrupting normal macular function. The purpose of this evaluation is to investigate a possible link between alterations in choroidal blood flow and the development of CNV and serous detachment in the fellow eye of patients with AMD and unilateral neovascular maculopathy. This longitudinal study may provide important findings with respect to natural history and visual prognosis of patients with neovascularized AMD. Ocular blood flow will be determined by non-invasive methods, including laser Doppler flowmetry and laser interferometry |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE | Regional Blood Flow | ||||
| Intervention ICMJE | Procedure: ocular blood flow measurement
Ocular blood flow will be determined by non-invasive methods, including laser Doppler flowmetry and laser interferometry |
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| Study Arm (s) | Experimental: 1
Observatory, longitudinal, 3-years follow up study
Intervention: Procedure: ocular blood flow measurement |
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| Publications * | Not Provided | ||||
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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 | ||||
| Estimated Enrollment ICMJE | 41 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Austria | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00808197 | ||||
| Other Study ID Numbers ICMJE | OPHT-140501 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Medical University of Vienna | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Medical University of Vienna | ||||
| Verification Date | December 2008 | ||||
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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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