Change of Retinally-Induced Aniseikonia in Patients With Epiretinal Membrane After Vitrectomy

August 11, 2014 updated by: Yonsei University
Epiretinal membrane is common disease, affecting 5~10 % incidence over 60 years old population. It reduce visual acuity, cause metamorphopsia. In the past, vitrectomy and epiretinal membranectomy was indicated in patients with visual acuity less than 20/40, but nowadays with technical improvement and surgical instrument renovation, it seems to have been changed the surgical indication. Therefore, we plan to evaluate the changes of binocular visual acuity, aniseikonia in patients with epiretinal membrane.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

24

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-720
        • Institute of Vision Research, Department of Ophthalmology, Gangnam Severance Hospital

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

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with epiretinal membrane who had metamorphopsia or had imparied vision, therefore planned to undergo vitrectomy

Description

Inclusion Criteria:

  • Idiopathic epiretinal membrane who had impaired vision or metamorphopsia, want to undergo vitrectomy
  • Age more than 20 years and less than 90 years old

Exclusion Criteria:

  • secondary epiretinal membrane due to retinal surgery,
  • impaired visual acuity less than 20/40 in the normal eye(Snellen chart) due to severe cataract
  • glaucoma patients
  • complication during vitrectomy (ex. Retinal tear, silicone oil injection, …)
  • other retinal disease except epiretinal membrane
  • other ocular surgery history within 3 months
  • intellectual problems or illiterate whom could not obtained informed consent

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
ERM
idiopathic epiretinal membrane patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of Stereopsis tested by TNO test (arc of second)
Time Frame: from Initial screening day before surgey to postoperative 6 months
Stereopsis is normal binocular vision. Its presence or absence is an important indicator of the state of binocularity. The TNO test is graded to provide retinal disparities ranging from 15 to 480 second of arc.
from Initial screening day before surgey to postoperative 6 months
Titmus test (arc of second)
Time Frame: from Initial screening day before surgey to postoperative 6 months
from Initial screening day before surgey to postoperative 6 months

Collaborators and Investigators

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

Sponsor

Yonsei University

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

July 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

July 2, 2013

First Submitted That Met QC Criteria

July 12, 2013

First Posted (Estimate)

July 17, 2013

Study Record Updates

Last Update Posted (Estimate)

August 12, 2014

Last Update Submitted That Met QC Criteria

August 11, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2013-0094

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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