Optical Coherence Tomography Angiography and Pseudophakic Cystoid Edema

• Sponsor: Federico II University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05117411
• Collaborator: (none)
• Enrollment: 25
• Actual Duration (Months): 60

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pseudophakic Cystoid Macular Edema	Diagnostic Test: OCTA and pseudophakin cystoid edema

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 Design

• Study Type: Observational
• Actual Enrollment: 25 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Peripapillary Vascular Density in the Pathogenesis of Pseudophakic Cystoid Edema
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Dec 15, 2020
• Actual Study Completion Date: Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Patients group Subjects over 18 years that after cataract surgery, showed pseudophakic cystoid macula edema.	Diagnostic Test: OCTA and pseudophakin cystoid edema; Patients underwent OCT angiografia after cataract surgery
Control Group Normal subjects over 18 years that did not show pseudophakic cystoid macula edema.	Diagnostic Test: OCTA and pseudophakin cystoid edema; Patients underwent OCT angiografia after cataract surgery

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Federico II University

Investigators

• Principal Investigator: Gilda Cennamo, Università Federico II

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gilda Cennamo, Principal Investigator, Federico II University
• ClinicalTrials.gov Identifier: NCT05117411
• Other Study ID Numbers: 09/21
• First Posted: Nov 11, 2021
• Last Update Posted: Nov 11, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Macular Edema; Edema

Study Results

No Results Posted as of Nov 11, 2021