NCT03832335

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 6, 2019

Status Verified

February 1, 2019

Enrollment Period

4.1 years

First QC Date

January 31, 2019

Last Update Submit

February 4, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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

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

Interventions

Adding sizeglasses of different percent before right and left eye and measure the impact on stereopsis

Cataract groupPhakic group

Eligibility Criteria

Age60 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • lack of cooperation
  • amblyopia
  • axial anisometropia
  • ametropia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet-glostrup

Glostrup Municipality, Danmark, 2600, Denmark

RECRUITING

MeSH Terms

Conditions

AniseikoniaAnisometropia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 31, 2019

First Posted

February 6, 2019

Study Start

July 1, 2015

Primary Completion

August 2, 2019

Study Completion

December 1, 2020

Last Updated

February 6, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations