An observational study in Age - Related Macular Degeneration (AMD), Diabetic Macular Edema and Diabetic Retinopathy, sponsored by IRCCS San Raffaele. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-30.
Sponsored by IRCCS San Raffaele · Observational
The main retinal diseases, whether or not associated with specific mutations genetic, cause progressive degeneration of vascular retinal structures and not vascular, resulting in decreased visual function. Often, such diseases affect the noblest part of the retina, called macula. Many retinal diseases can be complicated by choroidal neovascularization which causes frequent bleeding and fluid leakage that accumulates in the subretinal and intraretinal spaces. Although the investigators know many details of each disease affecting the retina, very often the correct diagnostic framework can be complicated, given the presence of morphological elements common to the different pathologies. Similarly, predicting the effect of treatment and the patient's outcome is a constant challenge for the ophthalmologists. Most of the current research has been focused on the assessment of vascular alterations localized in the macula. However, growing evidence highlight the importance of peripheral vascular changes on the outcome of retinal diseases. These changes can be detected only be wide field OCT devices.
On the other hand, ocular inflammation and hyperemia represent major assessments in anterior segment disorders, such as dry eye disease. The current grading systems of ocular inflammation, redness and hyperemia are characterized by several limitations, thus making these evaluations still mainly confined to the subjective assessment performed by the ophthalmologist. However, the new generation OCT devices may include also an anterior segment module which can reconstruct anterior segment vessels, non-invasively, using the same technology described for retinal diseases.
The main goal of the study is to evaluate the diagnostic contribution of a new generation wide field OCTA device in ocular diseases, which has recently received CE marking. In particular, the investigators will evaluate this new generation device both in retinal and anterior segments diseases, testing for common points and differences with the standard of care non-invasive diagnostic devices. Secondary outcomes include the assessment of the correlation between the patient's visual function (visual acuity) and morphological changes (standard of care imaging assessment) highlighted by the wide field OCT device, with particular attention to microstructural differences between major ocular diseases and the possible development of non-invasive biomarkers, useful for the diagnosis and follow-up of such pathologies.
Hypothesis: wide field OCT may remarkably contribute on the improvement of diagnostic workup and precision medicine of ocular diseases.
Design: Post-market medical device, monocentric trial. Both cross-sectional and prospective.
The number of study groups and study duration: patients affected by ocular diseases (age-related macular degeneration, diabetic retinopathy, inherited retinal dystrophies, uveitis, myopia, pachychoroid spectrum, dry eye) and healthy controls. Duration 2-years.
the investigators will not expect remarkable biases since our evaluation will be based on the statistical analysis of quantitative imaging metrics coming from the investigational device and the comparator devices.
Both patients and controls will undergo complete ophthalmology assessment and non-invasive imaging diagnostic investigation.
In this study, the investigators will employ one standard-of-care device-Heidelberg Spectralis for retinal imaging and Keratograph 4M for anterior segment evaluation-alongside DreamOCT as the comparator device, replacing the second standard-of-care device typically used in our clinic. This is accepted and agrees with study design since, for diagnostic devices, the procedure to obtain CE approval includes safety check and comparability with other existing devices. Hence, the above described procedure represents the standard of care methodology when testing a novel device in clinical practice.
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
This study's planned enrollment of 200 is above the median of 110 across 409 observational studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →IRCCS San Raffaele is the lead sponsor of 453 studies on the registry; 234 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients affected by ocular diseases and healthy controls to be considered as reference.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients affected by one of the following: AMD, diabetic retinopathy, pachychoroid spectrum, inherited retinal diseases, uveitis, ocular surface disorders
Retinal vessel density
Quantitative analysis of macular and peripheral capillary perfusion
Time frame: Cross-sectional investigation at baseline and after 1-year follow-up
Conjunctival vessel density
Conjuctival perfusion in ocular surface diseases
Time frame: Cross-sectional investigation at baseline and after 1-year follow-up
No study locations are listed for this record.
Plan to share: No — There is not a plan to make IPD available
No publications or documents are linked to this record.
Start is estimated for Jan 2026; primary completion for Jan 2028, 24 months later.
Of 104 non-industry observational studies under Macular Degeneration, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 98. This study's planned 24 months is below that.
Counting every sponsor, half of 160 studies reached it within 45 months; a quarter within 16 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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