NCT05117411

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 11, 2021

Completed
Last Updated

November 11, 2021

Status Verified

November 1, 2021

Enrollment Period

5 years

First QC Date

September 27, 2021

Last Update Submit

November 2, 2021

Conditions

Pseudophakic Cystoid Macular Edema

Outcome Measures

Primary Outcomes (1)

  • OCTA and pseudophakic cystoid macular oedema

    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

Study Arms (2)

Patients group

Subjects over 18 years that after cataract surgery, showed pseudophakic cystoid macula edema.

Diagnostic Test: OCTA and pseudophakin cystoid edema

Control Group

Normal subjects over 18 years that did not show pseudophakic cystoid macula edema.

Diagnostic Test: OCTA and pseudophakin cystoid edema

Interventions

OCTA and pseudophakin cystoid edemaDIAGNOSTIC_TEST

Patients underwent OCT angiografia after cataract surgery

Control GroupPatients group

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Gilda Cennamo

    Università Federico II

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 27, 2021

First Posted

November 11, 2021

Study Start

January 1, 2016

Primary Completion

December 15, 2020

Study Completion

December 30, 2020

Last Updated

November 11, 2021

Record last verified: 2021-11