Aniseikonia in Epiretinal Membrane Patients

September 5, 2018 updated by: Therese Krarup, Glostrup University Hospital, Copenhagen

Aniseikonia in Epiretinal Membranes

Examination of aniseikonia in epiretinal membranes patients before and after surgery

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Phakic patients woth epiretinal membranes are examined for aniseikonia and refractive status before and after surgery. Follow up is one year.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

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

  • Denmark
    • Glostrup
      • Copenhagen, Glostrup, Denmark, 2600
        • Recruiting
        • Eye department, Nordre ringvej 56
        • Contact:

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Epiretinal membrane Phakic on both eyes

Exclusion Criteria:

  • no previous eye surgeries
  • refractive status +/- 2 seq

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cataract guideline
In this patients we follow cataract guideline and correct the patients ametropia during the cataract surgery
Other: Cataract guideline
The patients gets an IOL according to cataract guideline correcting the ametropia
No Intervention: Standard refraction
The patients gets an IOL ensuring his preoperatively refraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aniseikonia
Time Frame: 1 year
Measure amount of aniseikonia by measuring aniseikonia with both computer program aniseikonia inspector and the New Aniseikonia test
1 year

Collaborators and Investigators

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

Sponsor

Glostrup University Hospital, Copenhagen

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)

November 1, 2017

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

August 31, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-16020057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No planing on sharing

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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