AniseikoniaNCT03832335
A New Measurement of Anseikonia Tolerance
An observational study of Aniseikonia and Anisometropia and Aniseikonia, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Aniseikonia, Anisometropia and Aniseikonia
- What is being tested?
- Measurement of aniseikonia tolerance
- How many people
- 31 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2015to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: group 1: eyehealthy pahkic individuls group 2: eyehalthy phakic patients awainting cataratc surgery
Who may be able to join
- No previous eye history
- cataract grade <= 1
- visual acuity above 0.8
Who cannot join
- lack of cooperation
- amblyopia
- axial anisometropia
- ametropia
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet-glostrup
Glostrup Municipality, Danmark, 2600
Therese Krarup, MD, +4528577271, theresekrarup@gmail.com
Birgit Sander, +4538633863, bisan@regionh.dk
About this study
Official title: 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
Read the 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.
- Conditions
- Aniseikonia, Anisometropia and Aniseikonia
- Being tested
- Measurement of aniseikonia tolerance
- Medical subject headings
- Aniseikonia, Anisometropia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of aniseikonia toleranceDiagnostic test
Adding sizeglasses of different percent before right and left eye and measure the impact on stereopsis
| Study group | Role | What they receive |
|---|---|---|
| Phakic group | 21 eyehealthy individuals examined for baseline stereopsis and impact of aniseikonia on stereopsis. An non-invasive measurement. Receives: 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. Receives: Diagnostic Test: Measurement of aniseikonia tolerance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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.
Measured: six weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study startJul 2015
- Primary completion2 Aug 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AniseikoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Therese Krarup, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832335
- Sponsor's protocol ID
- 04127
- Status last verified
- Feb 2019
- First submitted
- 31 Jan 2019
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can we Measure Aniseikonia Tolerance in a Normal Population
- ClinicalTrials.gov ID
- NCT03832335
- Acronym / sponsor ID
- 04127
- Conditions
- Aniseikonia, Anisometropia and Aniseikonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- 2 Aug 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phakic group | – | Diagnostic Test: Measurement of aniseikonia tolerance21 eyehealthy individuals examined for baseline stereopsis and impact of aniseikonia on stereopsis. An non-invasive measurement. |
| Cataract group | – | Diagnostic Test: Measurement of aniseikonia tolerance11 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. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- group 1: eyehealthy pahkic individuls group 2: eyehalthy phakic patients awainting cataratc surgery
Key inclusion criteria (3 listed)
- No previous eye history
- cataract grade <= 1
- visual acuity above 0.8
Key exclusion criteria (4 listed)
- lack of cooperation
- amblyopia
- axial anisometropia
- ametropia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of aniseikonia toleranceAdding sizeglasses of different percent before right and left eye and measure the impact on stereopsis | Diagnostic test | Cataract group, Phakic group |
Primary outcome
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%.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Aniseikonia
Recruiting
Virtual Reality Aniseikonia and Metamorphopsia Testing
Metamorphopsia, Aniseikonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aniseikonia and Anisometropia and Aniseikonia, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aniseikonia tolerance (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.