A New Measurement of Anseikonia Tolerance

Can we Measure Aniseikonia Tolerance in a Normal Population

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

Study Overview

• Status: Unknown
• Conditions: Aniseikonia; Anisometropia and Aniseikonia
• Intervention / Treatment: 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
• Enrollment (Anticipated): 31

Contacts and Locations

Study Locations

• Denmark
  • Danmark
    • Glostrup, Danmark, Denmark, 2600
      • Recruiting
      • Rigshospitalet-Glostrup
      • Contact: Therese Krarup, MD; Phone Number: +4528577271; Email: theresekrarup@gmail.com
      • Contact: Birgit Sander; Phone Number: +4538633863; Email: bisan@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years to 93 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

group 1: eyehealthy pahkic individuls group 2: eyehalthy phakic patients awainting cataratc surgery

Description

Inclusion Criteria:

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

Exclusion Criteria:

• lack of cooperation
• amblyopia
• axial anisometropia
• ametropia

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aniseikonia tolerance	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%.	baseline
Change of Aniseikonia tolerance 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.	six weeks after surgery

Collaborators and Investigators

• Sponsor: Glostrup University Hospital, Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Anticipated): August 2, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Actual): February 6, 2019
• Last Update Submitted That Met QC Criteria: February 4, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Aniseikonia; Anisometropia
• Other Study ID Numbers: 04127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No