OCTA and Retinal Angiomatous Proliferation

December 29, 2020 updated by: Gilda Cennamo, Federico II University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

118

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Napoli
      • Naples, Napoli, Italy, 80131
        • Federico II University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participans were older than 65 years with diagnosis of age-related macular degeneration and in particular retinal angiomatous proliferation and reticular pseudodrusen.

They did not present other ophthalmological diseases.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 20, 2020

Study Registration Dates

First Submitted

December 29, 2020

First Submitted That Met QC Criteria

December 29, 2020

First Posted (Actual)

December 30, 2020

Study Record Updates

Last Update Posted (Actual)

December 30, 2020

Last Update Submitted That Met QC Criteria

December 29, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2912/20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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