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OpenTrials
Completed

NCT Number: NCT03939195

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

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.

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Key information

Conditions

Macular Degeneration Exudative Eye Left Macular Degeneration Exudative Eye Right

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHI Créteil, Créteil, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follow-up

Other

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

Primary outcomes

  1. Fractal dimension (without unit)

    Time frame: 12 months

    Analysis of fractal dimension measured on OCT-A (Angiography Optical Coherence Tomography ) on 4 consecutive examinations.

  2. Fractal lacunarity (without unit)

    Time frame: 12 months

    Analysis of lacunarity measured by OCT-A on 4 consecutive examinations.

  3. Vascular density (%)

    Time frame: 12 months

    Analysis of vascular density measured by OCT-A on 4 consecutive examinations.

  4. Vascular surface (micronm2)

    Time frame: 12 months

    Analysis of vascular surface measured by OCT-A on 4 consecutive examinations.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Official study title

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

Acronym: QUAOBARE

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
May 6, 2019
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.