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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07143526
Enrollment
50
Registered
2025-08-27
Start date
2025-08-31
Completion date
2025-09-30
Last updated
2025-08-27

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

Conditions

AMD - Age-Related Macular Degeneration

Brief summary

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

Interventions

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.

Sponsors

University of Trieste
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity of the detection of neovascularisation in large pigment epithelium detachment by swept source optical coherence tomography devicesDay 1The 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.

Countries

France

Contacts

Primary ContactKamal El Majdoubi El Idrissi, MD
majkamal1995@gmail.com+33780410459

Outcome results

None listed

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