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Deep Learning OCT and OCTA in NVC

Sponsor
Federico II University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05969418
Collaborator
(none)
50
Enrollment
1
Location
5.7
Anticipated Duration (Months)
8.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Diagnostic test: using artificial intelligence to evaluate the changes OCT and OCTA parameter

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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Deep Learning OCT and OCTA Quantification in Neovascular Age Related Macular Degeneration
Actual Study Start Date :
Jul 1, 2023
Actual Primary Completion Date :
Jul 20, 2023
Anticipated Study Completion Date :
Dec 21, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. The measurements of retinal and choriocapillary vessel density in patients with macular degeneration complicated by nvc [more than sixmonths]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Federico II University Naples Italy 80121

Sponsors and Collaborators

  • Federico II University

Investigators

  • Study Chair: Ciro Costagliola, MD, Federico II University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gilda Cennamo, Doctor, Federico II University
ClinicalTrials.gov Identifier:
NCT05969418
Other Study ID Numbers:
  • 05809850
First Posted:
Aug 1, 2023
Last Update Posted:
Aug 7, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Macular Degeneration
Choroidal Neovascularization
Neovascularization, Pathologic

Study Results

No Results Posted as of Aug 7, 2023