OCTA (Optical Coherence Angiography Tomography) Versus Structural OCT(Optical Coherence Tomography) in Neovascular AMD (Age Macular Degeneration)

Completed

• Conditions: Macular Degeneration Exudative Eye Left; Macular Degeneration Exudative Eye Right

• Registration Number: NCT03939195
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

Brief Summary

The objective is to find if there is a relationship between the Fractal Dimension, the gap, vascular density (VD), the surface, the span ratio and the status of the choroidal neovessels to adjust the interval between 2 intravitreal injections nor on the qualitative aspect of Optical Coherence Structural Tomography but also on quantified quantitative and objective values.

Detailed Description

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 Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2019-01-11
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-06
• Primary Completion: 2019-07-01
• Status Verified: 2020-07
• Study Completion: 2020-07-01
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Man / woman over 50,
• Showing type 1 or type 2 CNV (choroidal neovessel) related to AMD during the second year of follow-up.
• Acceptance to participate in the protocol
• Affiliated to a social security scheme

Exclusion Criteria

• Type III CNV related to AMD,
• Other cause of CNV
• Signal less than 80 decibel and detachment of pigment epithelium (PED) greater than 250 μm on structural OCT B.
• Protected Majors (Guardianship, Curator, Safeguard of Justice)
• Participation in another interventional research.
• Refusal to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vascular surface (micronm2)	12 months	Analysis of vascular surface measured by OCT-A on 4 consecutive examinations.
Fractal lacunarity (without unit)	12 months	Analysis of lacunarity measured by OCT-A on 4 consecutive examinations.
Fractal dimension (without unit)	12 months	Analysis of fractal dimension measured on OCT-A (Angiography Optical Coherence Tomography ) on 4 consecutive examinations.
Vascular density (%)	12 months	Analysis of vascular density measured by OCT-A on 4 consecutive examinations.

Secondary Outcome Measures

Name	Time	Method
Relationship between fractal dimension measured by OCT-A and choroidal neovascular (CNV) status	12 months	Investigation of a relationship between fractal dimension mesured on OCT-A and the status of choroidal neovessels
Relationship between vascular surface measured by OCT-A and choroidal neovascular (CNV) status	12 months	Investigation of a relationship between vascular surface and the status of choroidal neovessels
Relationship between fractal lacunarity measured by OCT-A and choroidal neovascular (CNV) status	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	12 months	Investigation of a relationship between vascula density and the status of choroidal neovessels

Trial Locations

Locations (3)

CHI Créteil; 🇫🇷 Créteil, France

Centre Bergouignan; 🇫🇷 Évreux, France

Centre d'exploration ophtalmologique de l'odéon; 🇫🇷 Paris, France