GlaucomaNCT03365245
Partial Least Squares Regression Modelling for Glaucoma Detection
A study testing Microperimetry and automated visual field in people with Glaucoma, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
A partial least squares regression model for visual field testing among glaucoma patients will be developed. In addition, microperimetry will be compared to conventional perimetry and reproducibility will be assessed. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Microperimetry and automated visual field
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2015to Nov 2016
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 and older
- written informed consent prior to surgery
- any glaucoma-associated changes in one or both eyes (i.e. increased intraocular pressure, optic disc changes, known visual field defects) in the "glaucoma patients" and the absence of any glaucoma associated changes in the "healthy eyes group".
Who cannot join
- Secondary glaucoma
- In case of pregnancy (pregnancy test will be taken in women of reproductive age)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Partial Least Squares Regression Modelling for Glaucoma Detection Using Retinal Nerve Fiber Layer, Ganglion Cell Layer and Visual Field Data
A partial least squares regression model for visual field testing among glaucoma patients will be developed.
In addition, microperimetry will be compared to conventional perimetry and reproducibility will be assessed.
Read the detailed description
Aim of this study is to develop a partial least squares regression model incorporating retinal nerve fiber layer (RNFL) and retinal ganglion cell layer (RGCL) measurements as well as visual field testing to represent a glaucoma expert opinion on the stage of glaucoma.
In addition, microperimetry will be compared to conventional perimetry and reproducibility will be assessed.
- Conditions
- Glaucoma
- Being tested
- Microperimetry, automated visual field
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroperimetryDevice
Microperimetry is performed at three different days
automated visual fieldDevice
Automated visual field ist performed at three different days
| Study group | Role | What they receive |
|---|---|---|
| study arm | Other | Microperimetry and automated visual field are performed at three different days Receives: Device: Microperimetry; Device: automated visual field |
What is being measured
The primary outcome is the main question the study is designed to answer.
partial least square regression
Development of a partial least squares regression model to detect glaucoma
Measured: one month
Secondary outcomes (3)
reproducibility
Comparison of reproducibility of microperimetry and visual field testing
Measured: one month
Retinal nerve fiber thickness (RNFL) and the the retinal ganglion cell layer (RGCL)
The retinal nerve fiber layer thickness and the thickness of the retinal ganglion cell layer will be compared
Measured: one month
Microperimetry versus visual field testing
Comparison of microperimetry and visual field testing
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study startAug 2015
- Primary completionNov 2016
- Study completionNov 2016
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, MD, Principal investigator, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365245
- Sponsor's protocol ID
- PLSR
- Status last verified
- Dec 2017
- First submitted
- 4 Nov 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Least Squares Regression Modelling for Glaucoma Detection Using Retinal Nerve Fiber Layer, Ganglion Cell Layer and Visual Field Data
- ClinicalTrials.gov ID
- NCT03365245
- Acronym / sponsor ID
- PLSR
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 7 Dec 2017 (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.
A partial least squares regression model for visual field testing among glaucoma patients will be developed.
In addition, microperimetry will be compared to conventional perimetry and reproducibility will be assessed.
Detailed description
Aim of this study is to develop a partial least squares regression model incorporating retinal nerve fiber layer (RNFL) and retinal ganglion cell layer (RGCL) measurements as well as visual field testing to represent a glaucoma expert opinion on the stage of glaucoma.
In addition, microperimetry will be compared to conventional perimetry and reproducibility will be assessed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study arm | Other | Device: Microperimetry, Device: automated visual fieldMicroperimetry and automated visual field are performed at three different days |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 21 and older
- written informed consent prior to surgery
- any glaucoma-associated changes in one or both eyes (i.e. increased intraocular pressure, optic disc changes, known visual field defects) in the "glaucoma patients" and the absence of any glaucoma associated changes in the "healthy eyes group".
Key exclusion criteria (2 listed)
- Secondary glaucoma
- In case of pregnancy (pregnancy test will be taken in women of reproductive age)
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 |
|---|---|---|
| MicroperimetryMicroperimetry is performed at three different days | Device | study arm |
| automated visual fieldAutomated visual field ist performed at three different days | Device | study arm |
Primary outcome
partial least square regression
Time frame: one month
Development of a partial least squares regression model to detect glaucoma
3 secondary outcomes
reproducibility
Time frame: one month
Retinal nerve fiber thickness (RNFL) and the the retinal ganglion cell layer (RGCL)
Time frame: one month
Microperimetry versus visual field testing
Time frame: one month
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 7 Dec 2017.
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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.
Oliver Findl, MD principal investigator
Vienna Institute for Research in Ocular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microperimetry and automated visual field in people with Glaucoma, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
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 2 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 7 Dec 2017. 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 Austria. 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?
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?
partial least square regression (time frame: one month). 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 7 Dec 2017; AzTrials last refreshed its copy on 29 Oct 2026.