Morpho-functional Evaluation of the Retina and Choroid Using Multimodal Imaging in Healthy Subjects and Patients With Retino-choroidal Diseases (RET 05-26)
2026年9月2日 更新者：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.
研究概览
研究类型
观察性的
注册 (估计的)
125
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Parravano
- 电话号码：0684009442
- 邮箱：mariacristina.parravano@fondazionebietti.it
研究联系人备份
- 姓名：Costanzo
- 邮箱：eliana.costanzo@fondazionebietti.it
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
是的
取样方法
非概率样本
研究人群
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.
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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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.
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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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline in retinal thickness measured by OCT
大体时间：Baseline, 12, 24, 36, 48, and 60 months.
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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.
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Baseline, 12, 24, 36, 48, and 60 months.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from baseline in choroidal thickness measured by OCT
大体时间：Baseline, 12, 24, 36, 48, and 60 months.
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Change in choroidal thickness from baseline to each follow-up visit, measured by OCT and reported in micrometers (µm).
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Baseline, 12, 24, 36, 48, and 60 months.
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Change from baseline in retinal and/or choroidal vascular density measured by OCTA
大体时间：Baseline, 12, 24, 36, 48, and 60 months.
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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
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Baseline, 12, 24, 36, 48, and 60 months.
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Change from baseline in retinal sensitivity measured by microperimetry
大体时间：Baseline, 12, 24, 36, 48, and 60 months.
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Change in retinal sensitivity assessed by microperimetry and reported in decibels (dB).
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Baseline, 12, 24, 36, 48, and 60 months.
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Change from baseline in cone density measured by adaptive optics
大体时间：Baseline, 12, 24, 36, 48, and 60 months
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Change in cone density assessed by adaptive optics imaging and reported as cones/mm²
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Baseline, 12, 24, 36, 48, and 60 months
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Change from baseline in qualitative retinal and choroidal imaging features
大体时间：Baseline, 12, 24, 36, 48, and 60 months.
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Qualitative changes in retinal and choroidal morphology, reflectivity, autofluorescence patterns, and ultra-widefield retinal features, assessed by expert ophthalmologists using multimodal imaging.
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Baseline, 12, 24, 36, 48, and 60 months.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2033年6月1日
研究完成 (估计的)
2033年6月1日
研究注册日期
首次提交
2026年5月21日
首先提交符合 QC 标准的
2026年5月28日
首次发布 (实际的)
2026年5月29日
研究记录更新
最后更新发布 (实际的)
2026年9月4日
上次提交的符合 QC 标准的更新
2026年9月2日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.