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Morpho-functional Evaluation of the Retina and Choroid Using Multimodal Imaging in Healthy Subjects and Patients With Retino-choroidal Diseases (RET 05-26)

28. maj 2026 opdateret af: Fondazione G.B. Bietti, IRCCS

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

125

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in retinal thickness measured by OCT
Tidsramme: 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.
Baseline, 12, 24, 36, 48, and 60 months.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in choroidal thickness measured by OCT
Tidsramme: 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).
Baseline, 12, 24, 36, 48, and 60 months.
Change from baseline in retinal and/or choroidal vascular density measured by OCTA
Tidsramme: 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
Baseline, 12, 24, 36, 48, and 60 months.
Change from baseline in retinal sensitivity measured by microperimetry
Tidsramme: Baseline, 12, 24, 36, 48, and 60 months.
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
Tidsramme: Baseline, 12, 24, 36, 48, and 60 months
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
Tidsramme: 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.
Baseline, 12, 24, 36, 48, and 60 months.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fondazione G.B. Bietti, IRCCS

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juni 2033

Studieafslutning (Anslået)

1. juni 2033

Datoer for studieregistrering

Først indsendt

21. maj 2026

Først indsendt, der opfyldte QC-kriterier

28. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RET 05-26

Plan for individuelle deltagerdata (IPD)

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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