Morpho-functional Evaluation of the Retina and Choroid Using Multimodal Imaging in Healthy Subjects and Patients With Retino-choroidal Diseases

Valutazione Morfo-funzionale Della Retina e Della Coroide Mediante Imaging Multimodale in Soggetti Sani e in Pazienti Con Patologie Retino-coroideali

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07615699

Acronym

RET 05-26

Enrollment

125

Registered

2026-05-29

Start date

2026-10-01

Completion date

2033-06-01

Last updated

2026-09-04

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

Conditions

Choroidal Diseases, Healthy Subjects, Retinal Diseases

Brief summary

The purpose of this prospective, longitudinal, single-center observational study is to identify, describe, and measure the morpho-functional characteristics and modifications of the retina and choroid using advanced multimodal imaging techniques. The study will evaluate patients affected by retino-choroidal diseases and compare them with healthy controls over a 5-year follow-up period to track the evolution of these parameters over time.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* freely given informed consent acquired prior to the start of the study. * Participant's capacity to understand the informed consent and study procedures. * Age ≥ 6 years (with parental/guardian consent for minors). * Patients affected by any retino-choroidal disease. * Healthy subjects showing no retino-choroidal pathology.

Exclusion criteria

* Patient unable and/or unwilling to cooperate. * Presence of media opacities (dioptric media) that prevent image acquisition or significantly reduce the quality of the obtained images.

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in retinal thickness measured by OCT	Baseline, 12, 24, 36, 48, and 60 months.	Change in retinal thickness from baseline to each follow-up visit, measured by optical coherence tomography (OCT). Retinal thickness will be reported in micrometers (µm), including central macular thickness and/or retinal layer thicknesses, as applicable.

Secondary

Measure	Time frame	Description
Change from baseline in choroidal thickness measured by OCT	Baseline, 12, 24, 36, 48, and 60 months.	Change in choroidal thickness from baseline to each follow-up visit, measured by OCT and reported in micrometers (µm).
Change from baseline in retinal and/or choroidal vascular density measured by OCTA	Baseline, 12, 24, 36, 48, and 60 months.	Change in vascular parameters assessed by OCT angiography, including perfusion density, vessel length density, FAZ area, and/or choriocapillaris flow deficit, reported according to the specific metric generated by the device or analysis software
Change from baseline in retinal sensitivity measured by microperimetry	Baseline, 12, 24, 36, 48, and 60 months.	Change in retinal sensitivity assessed by microperimetry and reported in decibels (dB).
Change from baseline in cone density measured by adaptive optics	Baseline, 12, 24, 36, 48, and 60 months	Change in cone density assessed by adaptive optics imaging and reported as cones/mm²
Change from baseline in qualitative retinal and choroidal imaging features	Baseline, 12, 24, 36, 48, and 60 months.	Qualitative changes in retinal and choroidal morphology, reflectivity, autofluorescence patterns, and ultra-widefield retinal features, assessed by expert ophthalmologists using multimodal imaging.

Contacts

CONTACTParravano

mariacristina.parravano@fondazionebietti.it0684009442

CONTACTCostanzo

eliana.costanzo@fondazionebietti.it

Outcome results