OCTA (Optical Coherence Angiography Tomography) Versus Structural OCT(Optical Coherence Tomography) in Neovascular AMD (Age Macular Degeneration) (QUAOBARE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03939195|
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
|Condition or disease||Intervention/treatment|
|Macular Degeneration Exudative Eye Left Macular Degeneration Exudative Eye Right||Other: Follow-up|
This quantification is based on the analysis of fractal dimension (FD, without unit), lacunarity (Lac, without unit), vascular density (VD,%) and surface area of choroidal neovascular ( CNV, mm2).
The fractal dimension of a vascular structure corresponds to its degree of complexity. Fractals are models found in nature and biological systems that show self-similarity at different magnifications. It is obtained from the "box counting" method calculating the number of vascular segments contained in squares of varied size. Normal retinal vessels have a known and quantified complexity (FD = 1.7).
A neovascular tumor treated with anti-angiogenics will reduce vascular density, losing its random architecture; the investigators observe a return to a model standardized. NVCs have a random organization. The lower the FD, the more random the vascular architecture.
Lacunarity represents the texture or the homogeneity of a lesion, this one is heterogeneous when it is little vascularized and homogeneous if the vascularization is very dense. The lower the lake, the more homogeneous the lesion.
FD and Lac are obtained in Angiography Optical Coherence Tomography (OCTA) by the analysis of the hypersignal detected on the cut of the external retina.
The image is automatically binarised and skeletonized. NVC delineation is automatic and associated with automatic background noise processing. This software is fully automatic whose inter and intra grader reproducibility will be evaluated.
|Study Type :||Observational|
|Estimated Enrollment :||130 participants|
|Official Title:||OCTA Versus Structural OCT: Quantitative OCTA Biomarkers of Remission in Neovascular AMD|
|Actual Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2020|
- Other: Follow-up
4 follow-up visits with OCT Angiography and Structural OCT B
- Fractal dimension (without unit) [ Time Frame: 12 months ]Analysis of fractal dimension measured on OCT-A (Angiography Optical Coherence Tomography ) on 4 consecutive examinations.
- Fractal lacunarity (without unit) [ Time Frame: 12 months ]Analysis of lacunarity measured by OCT-A on 4 consecutive examinations.
- Vascular density (%) [ Time Frame: 12 months ]Analysis of vascular density measured by OCT-A on 4 consecutive examinations.
- Vascular surface (micronm2) [ Time Frame: 12 months ]Analysis of vascular surface measured by OCT-A on 4 consecutive examinations.
- Relationship between fractal dimension measured by OCT-A and choroidal neovascular (CNV) status [ Time Frame: 12 months ]Investigation of a relationship between fractal dimension mesured on OCT-A and the status of choroidal neovessels
- Relationship between fractal lacunarity measured by OCT-A and choroidal neovascular (CNV) status [ Time Frame: 12 months ]Investigation of a relationship between fractal lacunarity and the status of choroidal neovessels
- Relationship between vascular density measured by OCT-A and choroidal neovascular (CNV) status [ Time Frame: 12 months ]Investigation of a relationship between vascula density and the status of choroidal neovessels
- Relationship between vascular surface measured by OCT-A and choroidal neovascular (CNV) status [ Time Frame: 12 months ]Investigation of a relationship between vascular surface and the status of choroidal neovessels
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03939195
|Contact: Camille JUUNGfirstname.lastname@example.org|
|CHI Créteil||Not yet recruiting|
|Créteil, France, 94000|
|Contact: Eric Soueid|
|Centre d'exploration ophtalmologique de l'odéon||Recruiting|
|Contact: Florence Coscas, MD email@example.com|
|Centre Bergouignan||Not yet recruiting|
|Évreux, France, 27000|
|Contact: Jean-François BOULET firstname.lastname@example.org|