Optical Coherence Tomography Angiography and Pseudophakic Cystoid Edema

Completed

• Conditions: Pseudophakic Cystoid Macular Edema
• Interventions: Diagnostic Test: OCTA and pseudophakin cystoid edema

• Registration Number: NCT05117411
• Lead Sponsor: Federico II University

Brief Summary

This study evaluates the retinal vascular features in macula and papillary regions in patients affected by pseudophakic cystoid edema using optical coherence tomography angiography

Detailed Description

Pseudophakic cystoid edema represents one of the most common causes of poor visual outcome following cataratta surgery.

It is still source of debate the pathogenesis of Pseudophakic cystoid edema. Optical coherence tomography angiography represents a novel and non-invasive diagnostic technique that allows a detailed analysis of retinal vascular features. The study evaluates retrospectively the changes in optical coherence tomography angiography parameters at baseline and after three monthly after surgery.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-30
• Study First Submitted: 2021-09-27
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-02
• Last Update Submitted: 2021-11-02
• Study First Posted: 2021-11-11
• Last Update Posted: 2021-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• age older than 60 years
• diagnosis of pseudophakic cystoid macular oedema
• treatment-naïve for pseudophakic cystoid macular oedema
• absence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration)

Exclusion Criteria

• age younger than 60 years
• No diagnosis of pseudophakic cystoid macular oedema
• previous treatment for pseudophakic cystoid macular oedema
• presence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group	OCTA and pseudophakin cystoid edema	Normal subjects over 18 years that did not show pseudophakic cystoid macula edema.
Patients group	OCTA and pseudophakin cystoid edema	Subjects over 18 years that after cataract surgery, showed pseudophakic cystoid macula edema.

Primary Outcome Measures

Name	Time	Method
OCTA and pseudophakic cystoid macular oedema	3 months	The parameters analyzed by OCTA three months after surgery are: Vessel density (%) of superficial capillary plexus, deep capillary plexus, coriocapillary plexus in macular region Vessel density (%) of radial peripapillary capillary plexus in papilllary region