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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03832335
Other study ID # 04127
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 2015
Est. completion date December 2020

Study information

Verified date February 2019
Source Glostrup University Hospital, Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 31
Est. completion date December 2020
Est. primary completion date August 2, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 95 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Measurement of aniseikonia tolerance
Adding sizeglasses of different percent before right and left eye and measure the impact on stereopsis

Locations

Country Name City State
Denmark Rigshospitalet-glostrup Glostrup Danmark

Sponsors (1)

Lead Sponsor Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05325021 - Correction of Anisometropic Amblyopia in Children.