Epiretinal Membrane and Pseudophakic Cystoid Macular Edema

March 17, 2019 updated by: David Sierpina, Loma Linda University

Association of Cystoid Macular Edema After Cataract Surgery in Patients With and Without Epiretinal Membrane

Prospective, observational cohort study evaluating the association between pre-surgical existence of an epiretinal membrane (ERM) and the development of pseudophakic cystoid macular edema (PCME) using spectral domain optical coherence tomography (OCT) measurements.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients over 18 who are undergoing cataract surgery at Loma Linda University Eye Institute

Description

Inclusion Criteria:

  • 18 years or older
  • Cataract surgery patients

Exclusion Criteria:

  • Pre-existing macular edema
  • Choroidal neovascularization
  • Uveitis
  • Age-related macular degeneration
  • Myopia > 6 diopters
  • Proliferative diabetic retinopathy
  • Diabetics retinopathy great than mild in serverity

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
Study Group
Patients with diagnosed epiretinal membrane undergoing cataract surgery.
Control Group
Patients without epiretinal membrane undergoing cataract surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cystoid Macular Edema diagnosed by OCT
Time Frame: Within 90 days post op
Within 90 days post op

Collaborators and Investigators

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

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: David Sierpina, MD, Loma Linda University Medical Center

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)

February 1, 2016

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

February 24, 2016

First Submitted That Met QC Criteria

February 24, 2016

First Posted (Estimate)

February 26, 2016

Study Record Updates

Last Update Posted (Actual)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 17, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5150420

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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