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

NCT ID: NCT06436170

Last Updated: 2024-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-04-29

Brief Summary

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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

Detailed Description

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Conditions

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Cataract Macular Edema

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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30 patiens with IGS mean age 70 ±6

OCTA

Intervention Type DIAGNOSTIC_TEST

OCTA is a non invasive diagnostic technique to visualize RPC

30 healthy controls mean age 70 ±5

OCTA

Intervention Type DIAGNOSTIC_TEST

OCTA is a non invasive diagnostic technique to visualize RPC

Interventions

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OCTA

OCTA is a non invasive diagnostic technique to visualize RPC

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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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Minimum Eligible Age

58 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Gilda Cennamo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Federico II of Naples

Naples, , Italy

Site Status

Countries

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Italy

Other Identifiers

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05809852 Federico II

Identifier Type: -

Identifier Source: org_study_id

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