OCTA and Retinal Angiomatous Proliferation

Sponsor
Federico II University (Other)
Overall Status
Completed
CT.gov ID
NCT04689789
Collaborator
(none)
118
1
15.6
7.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: optical coherence tomography angiography

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
118 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Role of Quantitative Deep Capillary Plexus in the Pathogenesis of Retinal Angiomatous Proliferation: an Optical Coherence Tomography Angiography Study.
Actual Study Start Date :
Sep 1, 2019
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Dec 20, 2020

Arms and Interventions

Arm Intervention/Treatment
Patients with RAP

Patients with previous diagnosis of retinal angiomatous proliferation

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

Patients with reticular pseudodrusen

Patients with previous diagnosis of reticular pseudodrusen

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

Control group

Healthy eyes without actual and previous ocular diseases

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

Outcome Measures

Primary Outcome Measures

  1. The measurements of retinal vascular network in patients with age-related macular degeneration, using optical coherence tomography angiography, compared to controls [15 months]

    The parameters analyzed by optical coherence tomography angiography were: vessel density of superficial capillary plexus and deep capillary plexus

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Federico II University Naples Napoli Italy 80131

Sponsors and Collaborators

  • Federico II University

Investigators

  • Principal Investigator: Gilda Cennamo, Federico II University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gilda Cennamo, Principal Investigator, Federico II University
ClinicalTrials.gov Identifier:
NCT04689789
Other Study ID Numbers:
  • 2912/20
First Posted:
Dec 30, 2020
Last Update Posted:
Dec 30, 2020
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 30, 2020