Wide Field OCTA in Ocular Diseases

NCT07298174 | Not Yet Recruiting

• 1 other identifier: WOOD-2025
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

wide-field octa; multimodal retinal imaging; quantitative imaging; retinal disease; macular disease; ocular surface disease

Outcome Measures

Primary Outcomes (2)

• Retinal vessel density

  Quantitative analysis of macular and peripheral capillary perfusion

  Cross-sectional investigation at baseline and after 1-year follow-up

• Conjunctival vessel density

  Conjuctival perfusion in ocular surface diseases

  Cross-sectional investigation at baseline and after 1-year follow-up

Study Arms (1)

Patients affected by ocular diseases

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by ocular diseases and healthy controls to be considered as reference.

You may qualify if:

• Age \> 18 years
• Both genders
• Confirmed diagnosis of one of the above diseases
• Age-related macular degeneration
• Diabetic retinopathy
• Myopia
• Pachychoroid spectrum disease
• Inherited retinal dystrophy
• Uveitis
• Dry eye
• Visual acuity of at least 1/20
• Signed informed consent for the participation to the trial.

You may not qualify if:

• Media opacities
• Any other eye or systemic condition that may irreversibly impair the results of the study
• Surgery in the eye in the study, including cataract extraction, in the three months prior to recruitment

Sponsors & Collaborators

• IRCCS San Raffaele: lead

MeSH Terms

Conditions

Macular Degeneration; Diabetic Retinopathy; Myopia; Stargardt Disease; Retinitis Pigmentosa; Vitelliform Macular Dystrophy; Geographic Atrophy; Central Serous Chorioretinopathy; Uveitis; Retinal Vein Occlusion; Retinal Diseases

Condition Hierarchy (Ancestors)

Retinal Degeneration; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Refractive Errors; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Retinal Dystrophies; Uveal Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis

Central Study Contacts

Alessandro Arrigo, MD, PhD

CONTACT

+390226432648; arrigo.alessandro@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Head of Imaging Unit, Ophthalmology Department

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 23, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share