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A New Measurement of Anseikonia Tolerance

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ClinicalTrials.gov Identifier: NCT03832335
Recruitment Status : Recruiting
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Therese Krarup, Glostrup University Hospital, Copenhagen

Brief Summary:

Population 1:

Measure the effect of size glasses from1-9% on stereopsis

Population 2:

Measure the effect of size glasses from 1-9% on stereopsis in two settings:

  • before and after cataract surgery
  • after dilation of the eye

Condition or disease Intervention/treatment
Aniseikonia Anisometropia and Aniseikonia Diagnostic Test: Measurement of aniseikonia tolerance

Detailed Description:

Population 1:

21 eye healthy phakic individuals. Measurements: baseline stereopsis and stereopsis after size glass (1-9%) is added in front of the right eye and in front og the left eye. This measurement provides details on how much size difference a person can endure without impairing stereopsis.

Population 2:

11 phakic eye healthy individuals awaiting cataract operation on both eyes. Measurements are the same as population 1 but this study group is also measured after dilating the eyes. This is to see if accommodation affects the measurement. A postoperative measurement six weeks after cataract operation is also performed to examine if cataract operation affects the measurement.


Study Type : Observational
Estimated Enrollment : 31 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Can we Measure Aniseikonia Tolerance in a Normal Population
Actual Study Start Date : July 2015
Estimated Primary Completion Date : August 2, 2019
Estimated Study Completion Date : December 2020

Group/Cohort Intervention/treatment
Phakic group
21 eyehealthy individuals examined for baseline stereopsis and impact of aniseikonia on stereopsis. An non-invasive measurement.
Diagnostic Test: Measurement of aniseikonia tolerance
Adding sizeglasses of different percent before right and left eye and measure the impact on stereopsis

Cataract group
11 patients awaiting cataract surgery on both eyes. Measurement of baseline stereopsis and impact of artificial induced aniseikonia on stereopsis. A non invasive measurement that are repeated after dilatation of the eyes and again six weeks after surgery.
Diagnostic Test: Measurement of aniseikonia tolerance
Adding sizeglasses of different percent before right and left eye and measure the impact on stereopsis




Primary Outcome Measures :
  1. Aniseikonia tolerance [ Time Frame: baseline ]
    How many percent aniseikonia is tolerated before stereopsis is impaired. Measured by first measuring baseline stereopsis and here after adding aniseikonic (size glass) from 1-9% in front of the right and left eye to measure if stereopsis is impaired. If stereopsis is impaired at 4% sizeglas then aniseikonia tolerance is 4%.

  2. Change of Aniseikonia tolerance after surgery [ Time Frame: six weeks after surgery ]
    Measurement of aniseikonia tolerance before and after surgery. Measurement: before and after surgery stereopsis is measured, hereafter aniseikonic glasses (size glass) from 1-9% is added in front of the right and left eye to see if stereopsis is impaired. If stereopsis is impaired with 3% aniseikonic glass then the tolerance is 3%. After surgery the measurement is repeated to examine if the aniseikonia tolerance is the same.



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Ages Eligible for Study:   60 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
group 1: eyehealthy pahkic individuls group 2: eyehalthy phakic patients awainting cataratc surgery
Criteria

Inclusion Criteria:

  • No previous eye history
  • cataract grade <= 1
  • visual acuity above 0.8

Exclusion Criteria:

  • lack of cooperation
  • amblyopia
  • axial anisometropia
  • ametropia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03832335


Locations
Denmark
Rigshospitalet-glostrup Recruiting
Glostrup, Danmark, Denmark, 2600
Contact: Therese Krarup, MD    +4528577271    theresekrarup@gmail.com   
Contact: Birgit Sander    +4538633863    bisan@regionh.dk   
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen

Responsible Party: Therese Krarup, Principal investigator, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT03832335     History of Changes
Other Study ID Numbers: 04127
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anisometropia
Aniseikonia
Refractive Errors
Eye Diseases