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OpenTrials
Completed

NCT Number: NCT06436170

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

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

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases

Age range

58 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Federico II of Naples

Naples, 80121, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of PCME Cataract surgery

Exclusion criteria

diabetes vein occlusion uveitis vasculitis age-related macular degeneration hereditary macular dystrophy

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Treatment and study plan

OCTA

Diagnostic Test

OCTA is a non invasive diagnostic technique to visualize RPC

Primary outcomes

  1. the role of OCTA in diagnosis of IGS

    Time frame: 10 months

    To evaluate the vascolarization of RPC in IGS

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Acronym: OCTA and PMCE

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
May 30, 2024
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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