A New Measurement of Anseikonia Tolerance

• Conditions: Aniseikonia; Anisometropia and Aniseikonia
• Interventions: Diagnostic Test: Measurement of aniseikonia tolerance

• Registration Number: NCT03832335
• Lead Sponsor: 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

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 Timeline

• Study Start: 2015-07
• Study First Submitted: 2019-01-31
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-04
• Last Update Submitted: 2019-02-04
• Study First Posted: 2019-02-06
• Last Update Posted: 2019-02-06
• Primary Completion: 2019-08-02
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

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

Exclusion Criteria

• lack of cooperation
• amblyopia
• axial anisometropia
• ametropia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Phakic group	Measurement of aniseikonia tolerance	21 eyehealthy individuals examined for baseline stereopsis and impact of aniseikonia on stereopsis. An non-invasive measurement.
Cataract group	Measurement of aniseikonia tolerance	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.

Primary Outcome Measures

Name	Time	Method
Aniseikonia tolerance	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%.
Change of Aniseikonia tolerance after surgery	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.

Trial Locations

Locations (1)

Rigshospitalet-glostrup; 🇩🇰 Glostrup, Danmark, Denmark