Back to resultsAniseikonia in Epiretinal Membrane Patients
Primary Purpose
Epiretinal Membrane
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cataract guideline
Sponsored by
About this trial
This is an interventional other trial for Epiretinal Membrane
Eligibility Criteria
Inclusion Criteria:
- Epiretinal membrane Phakic on both eyes
Exclusion Criteria:
- no previous eye surgeries
- refractive status +/- 2 seq
Sites / Locations
- Eye department, Nordre ringvej 56Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cataract guideline
Standard refraction
Arm Description
In this patients we follow cataract guideline and correct the patients ametropia during the cataract surgery
The patients gets an IOL ensuring his preoperatively refraction
Outcomes
Primary Outcome Measures
Aniseikonia
Measure amount of aniseikonia by measuring aniseikonia with both computer program aniseikonia inspector and the New Aniseikonia test
Secondary Outcome Measures
Full Information
NCT ID
NCT03661593
First Posted
August 31, 2018
Last Updated
September 5, 2018
Sponsor
Glostrup University Hospital, Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT03661593
Brief Title
Aniseikonia in Epiretinal Membrane Patients
Official Title
Aniseikonia in Epiretinal Membranes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Glostrup University Hospital, Copenhagen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Examination of aniseikonia in epiretinal membranes patients before and after surgery
Detailed Description
Phakic patients woth epiretinal membranes are examined for aniseikonia and refractive status before and after surgery. Follow up is one year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiretinal Membrane
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Masking done by a third person following computer randomization
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cataract guideline
Arm Type
Experimental
Arm Description
In this patients we follow cataract guideline and correct the patients ametropia during the cataract surgery
Arm Title
Standard refraction
Arm Type
No Intervention
Arm Description
The patients gets an IOL ensuring his preoperatively refraction
Intervention Type
Other
Intervention Name(s)
Cataract guideline
Intervention Description
The patients gets an IOL according to cataract guideline correcting the ametropia
Primary Outcome Measure Information:
Title
Aniseikonia
Description
Measure amount of aniseikonia by measuring aniseikonia with both computer program aniseikonia inspector and the New Aniseikonia test
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Epiretinal membrane Phakic on both eyes
Exclusion Criteria:
no previous eye surgeries
refractive status +/- 2 seq
Facility Information:
Facility Name
Eye department, Nordre ringvej 56
City
Copenhagen
State/Province
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Therese Krarup, MD
Phone
+45 38633963
Email
theresekrarup@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No planing on sharing
Learn more about this trial
Aniseikonia in Epiretinal Membrane Patients
We'll reach out to this number within 24 hrs