Optical Coherence Tomography Angiography and Pseudophakic Cystoid Edema

November 2, 2021 updated by: Gilda Cennamo, Federico II University

Peripapillary Vascular Density in the Pathogenesis of Pseudophakic Cystoid Edema

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

25

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participans were older than 18 years with diagnosis of pseudophakic cystoid macular oedema. The participans did not present other ophthalmological diseases.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OCTA and pseudophakic cystoid macular oedema
Time Frame: 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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Investigators

  • Principal Investigator: Gilda Cennamo, Università Federico II

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 15, 2020

Study Completion (Actual)

December 30, 2020

Study Registration Dates

First Submitted

September 27, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (Actual)

November 11, 2021

Study Record Updates

Last Update Posted (Actual)

November 11, 2021

Last Update Submitted That Met QC Criteria

November 2, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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