Open Angle GlaucomaPlanimetryNCT02438319
Automatic vs. Manual Optic Disc Planimetry
An observational study of Open Angle Glaucoma, run by University of Zurich.
Trial summary
Manually and automatically by mashing learning algorithm optic disc will be evaluated (planimetry). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- manual planimetry and automated planimetry
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2017to 20 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with a diagnosis of open-angle glaucoma
Who may be able to join
- open-angle glaucoma
Who cannot join
- no fundus photography of the optic disc performed
About this study
Official title: Automatic vs. Manual Optic Cup and Optic Disc Segmentation in Glaucoma
Manually and automatically by mashing learning algorithm optic disc will be evaluated (planimetry).
Read the detailed description
Cross-Over non-randomized Case-Series. Arm 1 (Manual segmentation): Manually marking of the boundaries of the optic disc and it's excavation on color photographs of the optic disc. Arm 2 (Automated segmentation): Automatic detection of the boundaries of the optic disc and it's excavation. Calculation of cup size, size of excavation, cup-to-disc ratio, and rim area. Comparison of all parameters of both arms and computing of agreement.
- Conditions
- Open Angle Glaucoma
- Being tested
- manual planimetry, automated planimetry
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual planimetryOther
Manually marking of the boundaries of the optic disc and it's excavation on color photographs of the optic disc.
automated planimetryOther
Automatic detection of the boundaries of the optic disc and it's excavation on color photographs of the optic disc.
| Study group | Role | What they receive |
|---|---|---|
| patients with open angle glaucoma | patients with open angle glaucoma who had their optic discs routinely documented by fundus photography. Optic disc photographs will be analyzied by manual planimetry or automated planimetry. Receives: Other: manual planimetry; Other: automated planimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
agreement measured by kappa statistics
agreement measured by kappa statistics
Measured: Baseline visit in the outpatient department
Secondary outcomes (4)
Cup size
Cup size
Measured: Baseline visit in the outpatient department
size of excavation
size of excavation
Measured: Baseline visit in the outpatient department
vertical cup to disc ratio
vertical cup to disc ratio
Measured: Baseline visit in the outpatient department
rim area
rim area
Measured: Baseline visit in the outpatient department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study start1 Jul 2017
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Why it stopped: study was not started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open Angle 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Federal Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Jens Funk, MD, PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438319
- Sponsor's protocol ID
- Optic Disc Planimetry
- Acronym
- Planimetry
- Status last verified
- Mar 2020
- First submitted
- 29 Apr 2015
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jonas JB. [Glaucoma diagnosis of the optic disc using photography and planimetry]. Ophthalmologe. 2003 Jan;100(1):13-20. doi: 10.1007/s00347-002-0752-4. German.
PubMed 12557021
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic vs. Manual Optic Cup and Optic Disc Segmentation in Glaucoma
- ClinicalTrials.gov ID
- NCT02438319
- Acronym / sponsor ID
- Planimetry / Optic Disc Planimetry
- Conditions
- Open Angle Glaucoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: study was not started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss Federal Institute of Technology
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 8 May 2015 (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.
Manually and automatically by mashing learning algorithm optic disc will be evaluated (planimetry).
Detailed description
Cross-Over non-randomized Case-Series. Arm 1 (Manual segmentation): Manually marking of the boundaries of the optic disc and it's excavation on color photographs of the optic disc. Arm 2 (Automated segmentation): Automatic detection of the boundaries of the optic disc and it's excavation. Calculation of cup size, size of excavation, cup-to-disc ratio, and rim area. Comparison of all parameters of both arms and computing of agreement.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with open angle glaucoma | – | Other: manual planimetry, Other: automated planimetrypatients with open angle glaucoma who had their optic discs routinely documented by fundus photography. Optic disc photographs will be analyzied by manual planimetry or automated planimetry. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with a diagnosis of open-angle glaucoma
Key inclusion criteria (1 listed)
- open-angle glaucoma
Key exclusion criteria (1 listed)
- no fundus photography of the optic disc performed
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 |
|---|---|---|
| manual planimetryManually marking of the boundaries of the optic disc and it's excavation on color photographs of the optic disc. | Other | patients with open angle glaucoma |
| automated planimetryAutomatic detection of the boundaries of the optic disc and it's excavation on color photographs of the optic disc. | Other | patients with open angle glaucoma |
Primary outcome
agreement measured by kappa statistics
Time frame: Baseline visit in the outpatient department
agreement measured by kappa statistics
4 secondary outcomes
Cup size
Time frame: Baseline visit in the outpatient department
size of excavation
Time frame: Baseline visit in the outpatient department
vertical cup to disc ratio
Time frame: Baseline visit in the outpatient department
rim area
Time frame: Baseline visit in the outpatient department
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Background: PubMed 12557021Jonas JB. [Glaucoma diagnosis of the optic disc using photography and planimetry]. Ophthalmologe. 2003 Jan;100(1):13-20. doi: 10.1007/s00347-002-0752-4. German.
- Individual participant dataSharing planned: No
Related trials for Open Angle Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
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
University of Zurich
Questions about this trial
What is this clinical trial studying?
An observational study of Open Angle 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 26 Mar 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
agreement measured by kappa statistics (time frame: Baseline visit in the outpatient department). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02438319, which also lists 1 linked publication.
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 26 Mar 2020.