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 volunteersQualifiers
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
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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).
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
Change from baseline in retinal sensitivity measured by microperimetry
Change in retinal sensitivity assessed by microperimetry and reported in decibels (dB).
Change from baseline in cone density measured by adaptive optics
Change in cone density assessed by adaptive optics imaging and reported as cones/mm²
Locations
Sponsors and contacts
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