Morpho-functional Evaluation of the Retina and Choroid Using Multimodal Imaging in Healthy Subjects and Patients With Retino-choroidal Diseases (RET 05-26)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Retinal Diseases; Healthy Subjects; Choroidal Diseases

• Study Type: Observational
• Enrollment (Estimated): 125

Contacts and Locations

• Study Contact: Name: Parravano; Phone Number: 0684009442; Email: mariacristina.parravano@fondazionebietti.it
• Study Contact Backup: Name: Costanzo; Email: eliana.costanzo@fondazionebietti.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with Retino-Choroidal Diseases; Subjects of any gender, aged 6 years or older, diagnosed with any type of retino-choroidal pathology. Participants in this cohort will undergo multi-device structural and functional retinal/choroidal imaging monitoring over a 5-year follow-up period.
Healthy Controls; Healthy subjects of any gender, aged 6 years or older, who do not present with any active or historical retino-choroidal pathology. This group serves as a baseline comparison to evaluate normal morpho-functional retinal and choroidal trajectories over the 5-year study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 12, 24, 36, 48, and 60 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, 12, 24, 36, 48, and 60 months.
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	Baseline, 12, 24, 36, 48, and 60 months.
Change from baseline in retinal sensitivity measured by microperimetry	Change in retinal sensitivity assessed by microperimetry and reported in decibels (dB).	Baseline, 12, 24, 36, 48, and 60 months.
Change from baseline in cone density measured by adaptive optics	Change in cone density assessed by adaptive optics imaging and reported as cones/mm²	Baseline, 12, 24, 36, 48, and 60 months
Change from baseline in qualitative retinal and choroidal imaging features	Qualitative changes in retinal and choroidal morphology, reflectivity, autofluorescence patterns, and ultra-widefield retinal features, assessed by expert ophthalmologists using multimodal imaging.	Baseline, 12, 24, 36, 48, and 60 months.

Collaborators and Investigators

• Sponsor: Fondazione G.B. Bietti, IRCCS

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2033
• Study Completion (Estimated): June 1, 2033

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Retinal Diseases; Choroid Diseases
• Other Study ID Numbers: RET 05-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No