Wide Field OCTA in Ocular Diseases

Sponsor
IRCCS San Raffaele
Study ID
NCT07298174
Status
Not Yet Recruiting

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Conditions

  • Age - Related Macular Degeneration (AMD)
  • Best Disease
  • Central Serous Choroidopathy
  • Diabetic Macular Edema
  • Diabetic Retinopathy
  • Geographic Atrophy
  • Inherited Retinal Disease
  • Macular Neovascularisation
  • Myopia
  • Ocular Surface Disease
  • Pachychoroid Disease
  • Retinal Vein Occlusion
  • Retinitis Pigmentosa (RP)
  • Stargardt Disease
  • Uveitis
  • Vitreoretinal Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
Dec 23, 2025
Start date
Jan 31, 2026
Status verified
Dec 2025
Primary completion
Jan 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Patients affected by ocular diseases
    Patients affected by one of the following: AMD, diabetic retinopathy, pachychoroid spectrum, inherited retinal diseases, uveitis, ocular surface disorders

Primary Outcome Measure

Retinal vessel density [ Time Frame: Cross-sectional investigation at baseline and after 1-year follow-up ]

Central Contacts

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