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

NCT06436170 | Completed

• 1 other identifier: 05809852 Federico II
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Cataract; Macular Edema

Keywords

OCTA;RPC; IGS;PCME

Outcome Measures

Primary Outcomes (1)

• the role of OCTA in diagnosis of IGS

  To evaluate the vascolarization of RPC in IGS

  10 months

Study Arms (2)

30 patiens with IGS mean age 70 ±6

Diagnostic Test: OCTA

30 healthy controls mean age 70 ±5

Diagnostic Test: OCTA

Interventions

OCTA DIAGNOSTIC_TEST

OCTA is a non invasive diagnostic technique to visualize RPC

30 healthy controls mean age 70 ±5; 30 patiens with IGS mean age 70 ±6

Eligibility Criteria

• Age: 58 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with a diagnosis of PCME following phacoemulsification, addressed to our Unit, were enrolled in the study. The diagnostic criteria for PCME were: 1) vision loss in the operated eye within 3 months after surgery in patients with acute PCME and after 3 months for patients with chronic PCME; 2) changes on B-scan structural OCT with intraretinal cystoid spaces and central macular thickness (CMT) of at least 300 micron; 3) leakage and pooling of dye in macular cystoid spaces and late hyperfluorescence of the optic nerve head on FA. Clinical suspicion of PCME was confirmed using FA and structural OCT.

You may qualify if:

• Clinical diagnosis of PCME Cataract surgery

You may not qualify if:

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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University Federico II of Naples

Naples, 80121, Italy

Location

MeSH Terms

Conditions

Cataract; Macular Edema

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Macular Degeneration; Retinal Degeneration; Retinal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 30, 2024
• Study Start: July 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: April 29, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

IT (1)