OCTA and Retinal Angiomatous Proliferation

Age Related Macular Degeneration Clinical Trial

Official title:

The Role of Quantitative Deep Capillary Plexus in the Pathogenesis of Retinal Angiomatous Proliferation: an Optical Coherence Tomography Angiography Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04689789
• Other study ID #: 2912/20
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: December 20, 2020

Study information

• Verified date: December 2020
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To investigate, using optical coherence tomography angiography, the retinal vascular features in patients affected by RAP.

Description:

Retinal vascular anomalous complex represents a distinct form of neovascularization in patients with age-related macular degeneration.

The study investigated the changes in retinal vascular network using optical coherence tomography angiography, a novel and non invasive diagnostic technique that allows to better understand the pathophysiologic mechanism of this neovascularization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 20, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

Inclusion Criteria:

• age older than 65 years

• diagnosis of retinal angiomatous proliferation and reticular pseudodrusen

• absence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.

• absence of significant lens opacities, low-quality OCT-A images.

Exclusion Criteria:

• age older than 80 years

• absence of diagnosis of retinal angiomatous proliferation and reticular pseudodrusen

• presence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.

• presence of significant lens opacities, low-quality OCT-A images.

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Diagnostic Test:
• optical coherence tomography angiography
optical coherence tomography aniography is a non-invasive, fast, diagnostic imaging technique that evaluates the retinal vascular network

Locations

Country	Name	City	State
Italy	Federico II University	Naples	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The measurements of retinal vascular network in patients with age-related macular degeneration, using optical coherence tomography angiography, compared to controls	The parameters analyzed by optical coherence tomography angiography were: vessel density of superficial capillary plexus and deep capillary plexus	15 months