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NCT Number: NCT07615699

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

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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Key information

Conditions

Retinal Diseases Choroid Diseases Choroidal Diseases Eye Diseases Healthy Subjects Uveal Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change from baseline in retinal thickness measured by OCT

    Time frame: Baseline, 12, 24, 36, 48, and 60 months.

    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.

Secondary outcomes

  1. Change from baseline in choroidal thickness measured by OCT

    Time frame: Baseline, 12, 24, 36, 48, and 60 months.

    Change in choroidal thickness from baseline to each follow-up visit, measured by OCT and reported in micrometers (µm).

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

    Time frame: Baseline, 12, 24, 36, 48, and 60 months.

    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

  3. Change from baseline in retinal sensitivity measured by microperimetry

    Time frame: Baseline, 12, 24, 36, 48, and 60 months.

    Change in retinal sensitivity assessed by microperimetry and reported in decibels (dB).

  4. Change from baseline in cone density measured by adaptive optics

    Time frame: Baseline, 12, 24, 36, 48, and 60 months

    Change in cone density assessed by adaptive optics imaging and reported as cones/mm²

  5. Change from baseline in qualitative retinal and choroidal imaging features

    Time frame: Baseline, 12, 24, 36, 48, and 60 months.

    Qualitative changes in retinal and choroidal morphology, reflectivity, autofluorescence patterns, and ultra-widefield retinal features, assessed by expert ophthalmologists using multimodal imaging.

Study contacts

Contact information is provided by the study sponsor or research team.

Costanzo

CONTACT

[email protected]

Parravano

CONTACT

[email protected]

0684009442

Sponsors and collaborators

Lead sponsor

Fondazione G.B. Bietti, IRCCS

Other

Registry information

Official study title

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

Acronym: RET 05-26

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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