Morpho-functional Evaluation of the Retina and Choroid Using Multimodal Imaging in Healthy Subjects and Patients With Retino-choroidal Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Retinal Diseases, Choroidal Diseases, Healthy Subjects. Basic parameters: from 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Valutazione Morfo-funzionale Della Retina e Della Coroide Mediante Imaging Multimodale in Soggetti Sani e in Pazienti Con Patologie Retino-coroideali
Overview
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.
Primary outcome measures
- Change from baseline in retinal thickness measured by OCT [Time frame: Baseline, 12, 24, 36, 48, and 60 months.]
Secondary outcome measures (5)
- Change from baseline in choroidal thickness measured by OCT [Time frame: Baseline, 12, 24, 36, 48, and 60 months.]
- Change from baseline in retinal and/or choroidal vascular density measured by OCTA [Time frame: Baseline, 12, 24, 36, 48, and 60 months.]
- Change from baseline in retinal sensitivity measured by microperimetry [Time frame: Baseline, 12, 24, 36, 48, and 60 months.]
- Change from baseline in cone density measured by adaptive optics [Time frame: Baseline, 12, 24, 36, 48, and 60 months]
- Change from baseline in qualitative retinal and choroidal imaging features [Time frame: Baseline, 12, 24, 36, 48, and 60 months.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07615699 · RET 05-26