Deep Learning OCT and OCTA in NVC

August 3, 2023 updated by: Gilda Cennamo, Federico II University

Deep Learning OCT and OCTA Quantification in Neovascular Age Related Macular Degeneration

To evaluate the activity of neovascular macula degeneretion as assessed by SD-OCTand OCT-A using a split-person study design and deep-learning quantification.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Exudative neovascular macular degeneration is the primarily an age-related retinal condition The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features in order to choose the best therapy .

The study evaluates the changes in structural optical coherence tomography and optical coherence tomography angiography features in neovascular macular degeration patients undergoing ANTI-VEGF treatments using artificial intelligence.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

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

Study Contact

Study Locations

  • Italy
      • Naples, Italy, 80121
        • Recruiting
        • Federico II University
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The participans were older than 50 years with diagnosis of neovascular macular degeneration. They did not present other ophthalmological disease

Description

Inclusion Criteria: age older than 50 years

  • diagnosis of neovascular macular degeneration
  • absence of previous retinal surgery and congenital eye diseases.
  • absence of errors of refraction
  • absence of lens opacities
  • absence of low-quality OCT and OCTA images

Exclusion Criteria:• age younger than 50 years

  • previous retinal surgery and congenital eye diseases
  • errors of refraction
  • lens opacities
  • low-quality OCT and OCTA 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 neovascular macular degeneration
Diagnostic test: Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter
Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter before and after ANTI-VEGF treatment
healty patients matched age and sex without any ocular disease
Diagnostic test: Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter
Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter before and after ANTI-VEGF treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The measurements of retinal and choriocapillary vessel density in patients with macular degeneration complicated by nvc
Time Frame: more than sixmonths
more than sixmonths

Collaborators and Investigators

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

Sponsor

Federico II University

Investigators

  • Study Chair: Ciro Costagliola, MD, 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)

July 1, 2023

Primary Completion (Actual)

July 20, 2023

Study Completion (Estimated)

December 21, 2023

Study Registration Dates

First Submitted

July 23, 2023

First Submitted That Met QC Criteria

July 23, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05809850

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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