GlaucomaNCT02966678
Incidence of Dyschromatopsia in Glaucoma
An observational study of Glaucoma, run by University of Zurich.
Trial summary
Incidence of dyschromatopsia Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Color Vision Test
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 8 Nov 2016to 30 May 2017
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of glaucoma from a university outpatient department
Who may be able to join
- diagnosis of glaucoma
- age between 18 and 99 years old
- best corrected visual acuity(BCVA) > 0.2 (decimal Snellen)
Who cannot join
- age < 18 yo
- BCVA < 0.2
- known dyschromatopsia
- known corneal disease
- St.p. corneal surgeries
- macula disease
- history of medication use that can influence color vision (e.g. hydroxychloroquine)
About this study
Incidence of dyschromatopsia
Read the detailed description
Incidence of dyschromatopsia should be elevated in glaucoma compared to a healthy control population. However, the actual incidence rate is not investigated.
- Conditions
- Glaucoma
- Being tested
- Color Vision Test
- Keywords
- Glaucoma, Dychromatopsia
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Color Vision TestProcedure or surgery
Farnsworth Panel D15/Hue test plus Ishihara charts
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma | Patients with a diagnosis of glaucoma will undergo color vision test Receives: Procedure: Color Vision Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dyschromatopsia
Incidence of dyschromatopsia should be elevated in glaucoma compared to a healthy control population. However, the actual incidence rate is not investigated.
Measured: first and only study visit (day 1 of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study start8 Nov 2016
- Primary completion30 May 2017
- Study completion30 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Funk, MD, PhD, Principal investigator, UniversityHospital Zurich, Dept. of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966678
- Sponsor's protocol ID
- Dyschromatopsia
- Status last verified
- Jun 2017
- First submitted
- 7 Nov 2016
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Dyschromatopsia in Glaucoma
- ClinicalTrials.gov ID
- NCT02966678
- Acronym / sponsor ID
- Dyschromatopsia
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Dychromatopsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 8 Nov 2016 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 17 Nov 2016 (estimated)
- 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.
Incidence of dyschromatopsia
Detailed description
Incidence of dyschromatopsia should be elevated in glaucoma compared to a healthy control population. However, the actual incidence rate is not investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glaucoma | – | Procedure: Color Vision TestPatients with a diagnosis of glaucoma will undergo color vision test |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of glaucoma from a university outpatient department
Key inclusion criteria (3 listed)
- diagnosis of glaucoma
- age between 18 and 99 years old
- best corrected visual acuity(BCVA) > 0.2 (decimal Snellen)
Key exclusion criteria (7 listed)
- age < 18 yo
- BCVA < 0.2
- known dyschromatopsia
- known corneal disease
- St.p. corneal surgeries
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 |
|---|---|---|
| Color Vision TestFarnsworth Panel D15/Hue test plus Ishihara charts | Procedure or surgery | Glaucoma |
Primary outcome
Incidence of dyschromatopsia
Time frame: first and only study visit (day 1 of the study)
Incidence of dyschromatopsia should be elevated in glaucoma compared to a healthy control population. However, the actual incidence rate is not investigated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Jens Funk, MD, PhD principal investigator
UniversityHospital Zurich, Dept. of Ophthalmology
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by University of Zurich.
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 7 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: finished, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dyschromatopsia (time frame: first and only study visit (day 1 of the study)). 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 20 Jun 2017.