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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Parravano | Contact | 0684009442 | mariacristina.parravano@fondazionebietti.it | |
| Costanzo | Contact | eliana.costanzo@fondazionebietti.it |
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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. |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D015862 | Choroid Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
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