Non-invasive Optical Angiography in Age-related Macular Degeneration

NCT ID: NCT02521142

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2023-12-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

AMD: treatment-naive

Non-invasive OCT based optical angiography

Intervention Type: OTHER

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.

Oxymap T1

Intervention Type: OTHER

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.

OCT

Intervention Type: OTHER

non-invasive imaging of retinal and choroidal structures.

FLA/ICG angiography

Intervention Type: OTHER

Fluorescein Angiography and Indocianine Angiography

AMD: active neovascular AMD

Non-invasive OCT based optical angiography

Intervention Type: OTHER

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.

Oxymap T1

Intervention Type: OTHER

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.

OCT

Intervention Type: OTHER

non-invasive imaging of retinal and choroidal structures.

FLA/ICG angiography

Intervention Type: OTHER

Fluorescein Angiography and Indocianine Angiography

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

OCT

non-invasive imaging of retinal and choroidal structures.

Intervention Type: OTHER

FLA/ICG angiography

Fluorescein Angiography and Indocianine Angiography

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with active CNV due to AMD as assessed by FLA/ICG angiography within 1 week prior to study inclusion

Exclusion Criteria

Any of the following will exclude a patient from the study:

• Previous application of intravitreal drugs except anti-VEGF injections
• Active intraocular inflammation
• Presence of an intraocular disease except AMD and cataract

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Stefan Sacu

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Andreas Pollreisz, MD

Role: CONTACT

andreas.pollreisz@meduniwien.ac.at

+4314040048470

Facility Contacts

Reinhard Told, MD, PhD

Role: primary

+43140400 ext. 48470

References

Told R, Reumueller A, Schranz M, Brugger J, Weigert G, Reiter GS, Sacu S, Schmidt-Erfurth U. OCTA Biomarker Search in Patients with nAMD: Influence of Retinal Fluid on Time-Dependent Biomarker Response. Curr Eye Res. 2023 Jun;48(6):600-604. doi: 10.1080/02713683.2023.2184318. Epub 2023 Mar 9.

Reference Type: DERIVED

PMID: 36891909 (View on PubMed)

Other Identifiers

NOAA

Identifier Type: -

Identifier Source: org_study_id