## Protocol Section
### Identification Module
**NCT ID:** NCT06436170

**Acronym:** OCTA and PMCE

**Brief Title:** The Role of Radial Peripapillary Vessel Density in Irvine-gass Syndrome

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

#### Organization Study ID Info
**ID:** 05809852 Federico II
#### Organization
**Class:** OTHER
**Full Name:** Federico II University
### Status Module
#### Completion Date
**Date:** 2024-04-29

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-12-30

**Type:** ACTUAL

#### Start Date
**Date:** 2023-07-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Federico II University

#### Responsible Party

**Investigator Affiliation:** Federico II University

**Investigator Full Name:** Gilda Cennamo

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Cataract

- Macular Edema

**Keywords:**

- OCTA;RPC; IGS;PCME

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Diagnostic Test: OCTA

**Label:** 30 patiens with IGS mean age 70 ±6

#### Arm Group 2

**Intervention Names:**

- Diagnostic Test: OCTA

**Label:** 30 healthy controls mean age 70 ±5

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 30 healthy controls mean age 70 ±5

- 30 patiens with IGS mean age 70 ±6

**Description:** OCTA is a non invasive diagnostic technique to visualize RPC

**Name:** OCTA

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** To evaluate the vascolarization of RPC in IGS

**Measure:** the role of OCTA in diagnosis of IGS

**Time Frame:** 10 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Clinical diagnosis of PCME Cataract surgery

Exclusion Criteria:

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

-

**Healthy Volunteers:** True

**Maximum Age:** 75 Years

**Minimum Age:** 58 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Naples

**Country:** Italy

**Facility:** University Federico II of Naples

**Zip:** 80121

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007905

- Term: Lens Diseases

- ID: D000005128

- Term: Eye Diseases

- ID: D000008268

- Term: Macular Degeneration

- ID: D000012162

- Term: Retinal Degeneration

- ID: D000012164

- Term: Retinal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC11

- Name: Eye Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M5638

- Name: Cataract

- Relevance: HIGH

- As Found: Cataract

- ID: M11261

- Name: Macular Edema

- Relevance: HIGH

- As Found: Irvine-Gass Syndrome

- ID: M7657

- Name: Edema

- Relevance: LOW

- As Found: Unknown

- ID: M10917

- Name: Lens Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11260

- Name: Macular Degeneration

- Relevance: LOW

- As Found: Unknown

- ID: M14997

- Name: Retinal Degeneration

- Relevance: LOW

- As Found: Unknown

- ID: M14999

- Name: Retinal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002386

- Term: Cataract

- ID: D000008269

- Term: Macular Edema

### Misc Info Module

- Version Holder: 2024-05-31
