NCT02521142

Non-invasive Optical Angiography in Age-related Macular Degeneration

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 72 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Age-related macular degeneration (AMD) is the leading cause of severe and irreversible visual loss and classified blindness in the elderly throughout Europe and the US. Among these patients, about 6%-8% are afflicted with the advanced stages of AMD, which are responsible for the most severe visual loss. There is now convincing evidence that vascular endothelial growth factor (VEGF) is a major trigger for the formation of pathological choroidal vessels, responsible for the development of the neovascular form of AMD. Today, the gold standard for vascular imaging of the retina and diagnosis of CNV is angiography using fluorescein (FLA) or indocyanine green (ICG), which involves injection of the dye into a vein of the arm. In the recent years tremendous enhancements in the field of optical coherence tomography have been achieved. These developments made it possible to visualize the retinal vasculature in a full depth manner without the application of an intravenous marker. The proposed study tests the hypothesis that visualisation of CNV lesion size with non-invasive OCT angiography is not inferior to FLA/ICG angiography in treatment naïve and previously treated AMD patients.

Conditions

• Age Related Macular Degeneration

Interventions

Type	Name	Description
OTHER	Non-invasive OCT based optical angiography	This measurement will be obtained after the dilation of the pupil. Optical coherence tomography (OCT) is a non-invasive optical imaging modality enabling cross-sectional tomographic in vivo visualization of internal microstructure in biological systems. In ophthalmology OCT has become a standard device in visualizing the retina and is also considered a standard tool in the diagnosis of retinal disease. In optical angiography blood vessels contrasting against static tissue are visualized in a full depth resolved and label-free manner.
OTHER	Oxymap T1	The Oxymap system T1 is installed on a conventional fundus camera (Topcon TRC-50DX), which is operated as for color photography. The Oxymap T1 simultaneously acquires two images of the same area of the fundus at two different wavelengths of light. One of the two wavelengths is sensitive to oxygen saturation, i.e. the light absorbance changes with the oxygen saturation, while the other is insensitive to oxygen saturation and is used to calibrate the light intensity. The two spectral images are automatically processed by the Oxymap Analyzer software. Oxymap Analyzer detects blood vessels and estimates the light absorbance (optical density) at each point along the vessels at each wavelength. The ratio of the optical densities (optical density ratio or ODR) has been shown to be linearly related to hemoglobin oxygen saturation.
OTHER	OCT	non-invasive imaging of retinal and choroidal structures.
OTHER	FLA/ICG angiography	Fluorescein Angiography and Indocianine Angiography

Timeline

• Start date: 2015-11-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2015-08-13
• Last updated: 2023-01-17

Locations

1 site across 1 country: Austria