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

OCTA Versus Structural OCT: Quantitative OCTA Biomarkers of Remission in Neovascular AMD

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03939195
Acronym
QUAOBARE
Enrollment
130
Registered
2019-05-06
Start date
2018-12-01
Completion date
2020-07-01
Last updated
2020-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Degeneration Exudative Eye Left, Macular Degeneration Exudative Eye Right

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.

Interventions

OTHERFollow-up

4 follow-up visits with OCT Angiography and Structural OCT B

Sponsors

Centre Hospitalier Intercommunal Creteil
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Vascular surface (micronm2)12 monthsAnalysis of vascular surface measured by OCT-A on 4 consecutive examinations.
Fractal dimension (without unit)12 monthsAnalysis of fractal dimension measured on OCT-A (Angiography Optical Coherence Tomography ) on 4 consecutive examinations.
Fractal lacunarity (without unit)12 monthsAnalysis of lacunarity measured by OCT-A on 4 consecutive examinations.
Vascular density (%)12 monthsAnalysis of vascular density measured by OCT-A on 4 consecutive examinations.

Secondary

MeasureTime frameDescription
Relationship between fractal dimension measured by OCT-A and choroidal neovascular (CNV) status12 monthsInvestigation 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) status12 monthsInvestigation of a relationship between fractal lacunarity and the status of choroidal neovessels
Relationship between vascular density measured by OCT-A and choroidal neovascular (CNV) status12 monthsInvestigation of a relationship between vascula density and the status of choroidal neovessels
Relationship between vascular surface measured by OCT-A and choroidal neovascular (CNV) status12 monthsInvestigation of a relationship between vascular surface and the status of choroidal neovessels

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026