An observational study in Retinal Diseases, Choroidal Diseases and Healthy Subjects, sponsored by Fondazione G.B. Bietti, IRCCS. Not yet recruiting. Open to participants aged 6 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Fondazione G.B. Bietti, IRCCS · Observational
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.
333 studies on the registry are indexed under Retinal Diseases; 60 are open to participants now.
This study's planned enrollment of 125 is below the median of 200 across 118 observational studies indexed under Retinal Diseases.
Browse Retinal Diseases studies →Fondazione G.B. Bietti, IRCCS is the lead sponsor of 19 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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.
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.
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.
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.
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.
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
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.
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fondazione G.B. Bietti, IRCCS