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NCT06436170 Clinical Trial

The Role of Radial Peripapillary Vessel Density in Irvine-gass Syndrome

Cataract Clinical Trial

— OCTA and PMCE  

Official title:
Radial Peripapillary Vessel Density as a New Biomarker in Irvine-Gass Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06436170
Other study ID # 05809852 Federico II
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2023
Est. completion date April 29, 2024

Study information
Verified date May 2024
Source Federico II University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pseudophakic cystoid macular edema (PCME), also known as Irvine-Gass syndrome (IGS), is an accumulation of fluid in the macula that occurs after cataract surgery, with an early or late presentation (cut-off 3 months) . It is the most common cause of decreased vision after uneventful phacoemulsification, with a rare incidence of 0.1-2.35% for clinically significant PCME . Macular edema in IGS can be diagnosed and classified by optical coherence tomography (OCT), which enables its morphologic assessment. Fluorescein angiography (FA) is the gold standard to perform differential diagnosis for macular edema. To date, OCT angiography (OCTA) has been proposed to study various retinal vascular diseases. In contrast to FA, OCTA is able to visualize Radial peripapillary vessel density (RCP). The aim of this study was to investigate abnormalities in the vascular network of the optic nerve head in patients with IGS compared to healthy eyes, using OCT-A

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date April 29, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 58 Years to 75 Years
Eligibility Inclusion Criteria: Clinical diagnosis of PCME Cataract surgery Exclusion Criteria: diabetes vein occlusion uveitis vasculitis age-related macular degeneration hereditary macular dystrophy -

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• OCTA
OCTA is a non invasive diagnostic technique to visualize RPC

Locations
Country Name City State
Italy University Federico II of Naples Naples

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 role of OCTA in diagnosis of IGS To evaluate the vascolarization of RPC in IGS 10 months
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