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

Not yet recruiting

• Conditions: AMD - Age-Related Macular Degeneration

• Registration Number: NCT07143526
• Lead Sponsor: University of Trieste

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-08-01
• Study First Submitted: 2025-08-11
• Study First Submitted QC: 2025-08-19
• Last Update Submitted: 2025-08-19
• Study First Posted: 2025-08-27
• Last Update Posted: 2025-08-27
• Primary Completion: 2025-09
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Intercommunal de Créteil; 🇫🇷 Créteil, Val De Marne, France