BRUCH

Bruch’s Membrane’s Reflectivity: Understanding and Comparison using the High-Res OCT - BRUCH

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON58254

Enrollment

110

Registered

2025-02-13

Start date

2026-01-05

Completion date

Unknown

Last updated

2026-01-05

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

Conditions

Pseudoxanthoma Elasticum, Age-related macula degeneration, Glaucoma Pseudoxanthoma Elasticum, PXE, Age-related macula degeneration, AMD, Glaucoma

Interventions

High-Res OCT &amp

SPECTRALIS HRA+OCT - Heidelberg Engineering GmbH

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diagnosis with PXE with an early or intermediate disease progression.Early (dry) AMD diagnosis of an age below 75.Glaucoma diagnosis of an age below 75Other macular pathologiesAdult healthy controls (having a normal visual acuity and a normal fundus appearance), age matched with PXE patients.18 years or older at the time of OCT imaging.The participant may receive Tropicamide 0.5% & Phenylephrine Hydrochloride 2.5% in each eye to dilate the pupils (evaluated by a clinician).Proficiency in the Dutch languageSigned informed consent.

Exclusion criteria

Exclusion criteria: Diagnosis with PXE with an end stage of disease. E.g., Scarred, or atrophic macula leading to complicated OCT-evaluation.Subjects who are unable or unwilling to sign an informed consent.

Design outcomes

Primary

Measure	Time frame
The key metrics are retinal layer thickness (µm), intensity (dB or AU), and depth-resolved attenuation coefficient (mm?¹) measured from OCT. These parameters will be analysed to assess PXE-related patterns or differences, using the primary study parameters; Pearson’s or Spearman’s correlation to relate imaging metrics to disease progression (age or clinically classified stage). Clustering within patients due to correlation between the eyes is considered by using Generalized Estimating Equations (GEE).	—

Measure

Time frame

The key metrics are retinal layer thickness (µm), intensity (dB or AU), and depth-resolved attenuation coefficient (mm?¹) measured from OCT. These parameters will be analysed to assess PXE-related patterns or differences, using the primary study parameters; Pearson’s or Spearman’s correlation to relate imaging metrics to disease progression (age or clinically classified stage). Clustering within patients due to correlation between the eyes is considered by using Generalized Estimating Equations (GEE).

—

Secondary

Measure	Time frame
Secondary endpoints include repeatability and reproducibility of High-Res OCT via ICC, Bland–Altman plots, SEM, and between-group comparisons (PXE, AMD, glaucoma, controls) with effect sizes expressed as Cohen’s d.	—

Countries

Netherlands

Contacts

Public ContactSE Slootbeek

Universitair Medisch Centrum Utrecht

s.e.slootbeek@umcutrecht.nl088 75 74023

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)