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Not yet recruitingNCT07143526Updated Aug 27, 2025

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

An observational study in AMD - Age-Related Macular Degeneration, sponsored by University of Trieste. Not yet recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2025-08-27.

Sponsored by University of Trieste · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Sex
All
01

Study 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

02

Conditions studied

  • AMD - Age-Related Macular Degeneration
03

In context

Macular Degeneration

1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.

This study's planned enrollment of 50 is below the median of 110 across 409 observational studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

University of Trieste is the lead sponsor of 39 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients treated for neovascular age related macular degeneration (AMD)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Poor image quality or signal strength
  • Undefined retina layers
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testOptical Coherence Tomography Angiography (OCT-A)

    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.

06

What researchers measure

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.

    Time frame: Day 1

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2025; primary completion for Sep 2025, 1 month later.

Of 104 non-industry observational studies under Macular Degeneration, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 98. This study's planned 1 month is below that.

Counting every sponsor, half of 160 studies reached it within 45 months; a quarter within 16 and three quarters within 77.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2025
First posted
Aug 27, 2025
StartEst.
Aug 2025
Primary completionEst.
Sep 2025
CompletionEst.
Sep 2025
Last update
Aug 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07143526
Lead sponsor
University of Trieste
Responsible party
Marco Rocco Pastore (Department of Ophtalmology Clinical Assistant, University of Trieste) — Principal investigator
First posted
Aug 27, 2025
Start date
Aug 2025 (estimated)
Primary completion
Sep 2025 (estimated)
Completion
Sep 2025 (estimated)
Last update
Aug 27, 2025

Study contacts

Kamal El Majdoubi El Idrissi, MD
Contact
majkamal1995@gmail.com
+33780410459

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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