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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6+
SponsorFondazione G.B. Bietti, IRCCS

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The study population consists of both healthy volunteers and patients diagnosed with any type of retino-choroidal pathology. Participants will be selected from individuals who routinely attend or are referred to the outpatient clinics at the IRCCS Fondazione G. B. Bietti in Rome, Italy. The sample is designed to include a wide age range (age ≥ 6 years old) to capture the natural progression and morpho-functional characteristics of these conditions across different demographics. The cohort will feature a 4:1 allocation ratio, comprising 100 patients with retino-choroidal diseases and 25 age- and sex-matched healthy controls to ensure adequate statistical power for longitudinal progression analysis.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

125 Participants
are grouped into 2 trial groups
Group A: Patients with Retino-Choroidal Diseases
Group B: Healthy Controls

Trial outcomes

Primary outcomes

1

Change from baseline in retinal thickness measured by OCT

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.

Time frame
Baseline, 12, 24, 36, 48, and 60 months.

Secondary outcomes

1

Change from baseline in choroidal thickness measured by OCT

Change in choroidal thickness from baseline to each follow-up visit, measured by OCT and reported in micrometers (µm).

Time frame
Baseline, 12, 24, 36, 48, and 60 months.
2

Change from baseline in retinal and/or choroidal vascular density measured by OCTA

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

Time frame
Baseline, 12, 24, 36, 48, and 60 months.
3

Change from baseline in retinal sensitivity measured by microperimetry

Change in retinal sensitivity assessed by microperimetry and reported in decibels (dB).

Time frame
Baseline, 12, 24, 36, 48, and 60 months.
4

Change from baseline in cone density measured by adaptive optics

Change in cone density assessed by adaptive optics imaging and reported as cones/mm²

Time frame
Baseline, 12, 24, 36, 48, and 60 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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