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

NCT07143526 | Not Yet Recruiting

• 1 other identifier: 1030725
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

AMD - Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

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

  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.

  Day 1

Interventions

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated for neovascular age related macular degeneration (AMD)

You may qualify if:

• 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)

You may not qualify if:

• Poor image quality or signal strength
• Undefined retina layers

Sponsors & Collaborators

• University of Trieste: lead

Study Sites (1)

Centre Hospitalier Intercommunal de Créteil

Créteil, Val De Marne, 94000, France

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Kamal El Majdoubi El Idrissi, MD

CONTACT

+33780410459; majkamal1995@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Ophtalmology Clinical Assistant

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 27, 2025
• Study Start: August 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)