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

NCT07615699 | Not Yet Recruiting

• 1 other identifier: RET 05-26
• Study Type: observational
• Target: 125
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Retinal Diseases; Choroidal Diseases; Healthy Subjects

Outcome Measures

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.

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

Secondary Outcomes (5)

• Change from baseline in choroidal thickness measured by OCT

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

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

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

• Change from baseline in retinal sensitivity measured by microperimetry

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

• Change from baseline in cone density measured by adaptive optics

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

• Change from baseline in qualitative retinal and choroidal imaging features

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

Study Arms (2)

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.

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione G.B. Bietti, IRCCS: lead

MeSH Terms

Conditions

Retinal Diseases; Choroid Diseases

Condition Hierarchy (Ancestors)

Eye Diseases; Uveal Diseases

Central Study Contacts

Parravano

CONTACT

0684009442; mariacristina.parravano@fondazionebietti.it

Costanzo

CONTACT

eliana.costanzo@fondazionebietti.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 29, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2033
• Study Completion (Estimated): June 1, 2033
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share