"Cataract Surgery in Eyes With Epiretinal Membrane"

January 18, 2018 updated by: Barbara Wetzel, St John of God Hospital, Vienna

"Retinal Thickness Change Following Cataract Surgery in Eyes With Epiretinal Membrane"

The purpose of the study is to evaluate retinal thickness change and the occurrence of central structural retinal changes after uneventful small-incision cataract surgery in eyes with asymptomatic early stages of epiretinal membrane.

Study Overview

Status

Completed

Conditions

Detailed Description

Optical coherence tomography (OCT) is nowadays used in daily clinical practice and has become a helpful tool for detection of macular changes also in presence of opacification of the lens before cataract surgery. Using recent high-resolution OCT technology, early stages of epiretinal membranes can easily be detected and analysed. Since cataract surgery is one of the most frequently performed operations worldwide, this study was aimed to investigate the influence of uncomplicated cataract surgery on central retinal thickness and the incidence of structural and morphological macular changes after surgery in eyes with asymptomatic epiretinal membrane.

Study Type

Observational

Enrollment (Actual)

30

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 to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Thirty patients with visually compromising cataract and asymptomatic epiretinal membrane (ERM group) and 15 consecutive eyes with senile cataract with a healthy macula (control group) were included.

Description

Inclusion Criteria:

  • visually compromising cataract and asymptomatic early stages of epiretinal membrane with no structural changes such as cysts or photoreceptor distribution in optical coherence tomography.

Exclusion Criteria:

  • visual impairment or metamorphopsia due to epiretinal membrane
  • history of branch retinal vein occlusion
  • central retinal vein occlusion
  • wet or dry macular degeneration
  • diabetic retinopathy
  • uveitis or other inflammatory eye disease.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
central macular thickness
Time Frame: Change from Baseline central macular thickness at 3 months
Central 1-millimeter and 3-milimeter retinal thickness
Change from Baseline central macular thickness at 3 months

Collaborators and Investigators

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

Sponsor

St John of God Hospital, Vienna

Investigators

  • Principal Investigator: Barbara Wetzel, MD, St John of God Hospital, Vienna
  • Study Director: Georgios Mylonas, MD, St John of God Hospital, Vienna

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)

July 1, 2015

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

January 11, 2018

First Submitted That Met QC Criteria

January 18, 2018

First Posted (ACTUAL)

January 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 19, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15062015

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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