Comparison of the Sensibility of Swept Source Optical Coherence Tomography Devices in the Detection of Neovascularisation in Large Pigment Epithelium Detachments

The goal of this observational study is to compare swept source optical coherence tomography devices ability to detect macular neovascularisation when there is a large pigment epithelium detachment higher than 250 microns

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Key information

Conditions

AMD - Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Intercommunal de Créteil

Créteil, Val De Marne, 94000, France

Location contact

Kamal El Majdoubi El Idrissi, Medical Doctor

CONTACT

[email protected]

+33780410459

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients treated for neovascular age related macular degeneration (AMD)
Presence of a pigmentary epithelium detachment higher than 250 microns measured on structural optical coherence tomography (OCT)

Exclusion criteria

Poor image quality or signal strength
Undefined retina layers

Treatment and study plan

Optical Coherence Tomography Angiography (OCT-A)

Diagnostic Test

Two Optical Coherence Tomography Angiography swept source devices are compared for the detection of large pigment epithelium detachments in age related macular degeneration. The sensitivity of the devices is compared in both the automatic segmentation done by the device and the manual segmentation done by a retina specialist.

Primary outcomes

Sensitivity of the detection of neovascularisation in large pigment epithelium detachment by swept source optical coherence tomography devices

Time frame: Day 1

The optical coherence tomography angiography devices are known to have a difficult time detecting neovascularisation in the cases of large pigment epithelium detachments (PED), because of the many layers and the distance the OCT signal has to cross. The automatic retina segmentation (done by the device of the different retina layers plays a big role in this detection. It's also disturbed by the height of the PED.

This study aims to compare the sensitivity of two swept source OCT devices available in the market : Bmizar, Towardpi and Plexelite, Zeiss.

After the exam image acquisition, a retina specialist will try to make a manual segmentation of the retina analysed to help the detection of macular neovascularisation that would have been missed in the "normal" automatic segmentation done by the device.

Study contacts

Contact information is provided by the study sponsor or research team.

Kamal El Majdoubi El Idrissi, MD

CONTACT

[email protected]

+33780410459

Sponsors and collaborators

Lead sponsor

University of Trieste

Other

Registry information

Official study title

Comparison of Two Swept-source Optical Coherence Tomography Angiography (OCTA) Devices (Bmizar and Plexelite) for Detecting Macular Neovascularisation With Large (More Than 250 Microns) Pigment Epithelium Detachment (PED) in Age Related Macular Degeneration

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Aug 27, 2025
Registry last updated: Aug 27, 2025

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.

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