Open Angle GlaucomaLSFG ReproNCT04014933
Reproducibility of Blood Flowmetry in Human Retina Using the Nidek Laser Speckle Flowgraphy LSFG-NAVI System
An observational study of Open Angle Glaucoma and Normal Tension Glaucoma, run by University of Zurich at 1 site in Switzerland.
Trial summary
In addition to intraocular pressure blood perfusion pressure in the optic nerve is an important factor determing the cause of glaucoma. Increasing evidence suggests that in glaucoma patients retinal blood may be decreased. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Open Angle Glaucoma, Normal Tension Glaucoma, Healthy
- What is being tested?
- LASER SPECKLE FLOWGRAPHY
- How many people
- 44 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2019to 31 Dec 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 3 groups as described above will be recruted from the outpatient department of the Ophthalmology Department at the UniversityHospital Zurich, Zurich, Switzerland and the Ophthalmology Department at the Cantonal Hospital Aarau, Aarau, Switzerland
Who may be able to join
- signed Patient Informed Consent form
- Be at least 18 years old
- Diagnosis of primary or secondary open-angle glaucoma or normal tension glaucoma or healthy controls
Who cannot join
- Age < 18 years
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- No vulnerable participants will be included in this study.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Ophthalmology
Zurich, Canton of Zurich, 8091
About this study
Official title: Prospective, Non-randomised, Non-controlled Study of Reproducibility of Blood Flowmetry in Human Retina Using the Nidek Laser Speckle Flowgraphy LSFG-NAVI System
In addition to intraocular pressure blood perfusion pressure in the optic nerve is an important factor determing the cause of glaucoma. Increasing evidence suggests that in glaucoma patients retinal blood may be decreased.
Read the detailed description
According to the World Health Organization (WHO) glaucoma is the second leading cause of blindness. Glaucoma is a global problem, which is becoming even more important as the human life expectancy increases. Although the causes of glaucoma are uncertain, mainly intraocular pression (IOP), genetics, and ocular blood perfusion pressure in the optic nerve determine the cause of the disease. Increasing evidence suggests that in glaucoma patients retinal blood flow is decreased leading to progression and to damage of the optic nerve.
In order to measure the peripapillary blood flow a variety of devices using different techniques of flowmetry have been developed. In this study, the reproducibility of the retinal flowmetry measured with the LSFG-NAVI device from Nidek will be investigated. A high reproducibility is crucial for the clinical value of any measuring device.
- Conditions
- Open Angle Glaucoma, Normal Tension Glaucoma, Healthy
- Being tested
- LASER SPECKLE FLOWGRAPHY
- Keywords
- glaucoma, retinal blood flow, ocular perfusion pressure
- Medical subject headings
- Glaucoma, Open-Angle, Low Tension Glaucoma, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASER SPECKLE FLOWGRAPHYDiagnostic test
Non-invasive, real-time imaging and measurement of ocular blood flow of the optic disc and peripapillary region
| Study group | Role | What they receive |
|---|---|---|
| open-angle glaucoma | patients with a diagnosis of open-angle glaucoma, i.e. untreated IOP >21mmHg plus glaucomatous disc changes and/or visual field defects typical for glaucoma Receives: Diagnostic Test: LASER SPECKLE FLOWGRAPHY | |
| normal tension glaucoma | patients with a diagnosis of normal tension glaucoma, i.e. untreated IOP </=21mmHg plus glaucomatous disc changes and/or visual field defects typical for glaucoma Receives: Diagnostic Test: LASER SPECKLE FLOWGRAPHY | |
| healthy controls | individuals with normal optic disc and IOP </21mmHg and normal visual fields Receives: Diagnostic Test: LASER SPECKLE FLOWGRAPHY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coefficients of variation (COV)
COVs from 3 measurements of ocular blood flow at visit 1 of observer 1 and at visit 1 of observer 1 and from observer 2 will be computed.
Measured: 1 month
intraclass correlation coefficients (ICCs)
Intraobserver ICC, interobserver ICC, and inter-session ICC will be computed
Measured: 1 month
Secondary outcomes (4)
Cofounder
Blood pressure will be checked as potential cofounder
Measured: 1 month
Cofounder
heart rate will be checked as potential cofounder
Measured: 1 month
Cofounder
spherical equivalent will be checked as potential cofounder
Measured: 1 month
Cofounder
intraocular pressure will be checked as potential cofounder
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Jul 2019
- Primary completion9 Feb 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Töteberg-Harms, MD, FEBO, Principal investigator, UniversityHospital Zurich, Department of Ophthalmology, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014933
- Sponsor's protocol ID
- LSFG Repro
- Acronym
- LSFG Repro
- Status last verified
- Jun 2023
- First submitted
- 3 Jul 2019
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-randomised, Non-controlled Study of Reproducibility of Blood Flowmetry in Human Retina Using the Nidek Laser Speckle Flowgraphy LSFG-NAVI System
- ClinicalTrials.gov ID
- NCT04014933
- Acronym / sponsor ID
- LSFG Repro / LSFG Repro
- Conditions
- Open Angle Glaucoma, Normal Tension Glaucoma, Healthy
- Keywords
- glaucoma, retinal blood flow, ocular perfusion pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 9 Feb 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 10 Jul 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.
In addition to intraocular pressure blood perfusion pressure in the optic nerve is an important factor determing the cause of glaucoma. Increasing evidence suggests that in glaucoma patients retinal blood may be decreased.
Detailed description
According to the World Health Organization (WHO) glaucoma is the second leading cause of blindness. Glaucoma is a global problem, which is becoming even more important as the human life expectancy increases. Although the causes of glaucoma are uncertain, mainly intraocular pression (IOP), genetics, and ocular blood perfusion pressure in the optic nerve determine the cause of the disease. Increasing evidence suggests that in glaucoma patients retinal blood flow is decreased leading to progression and to damage of the optic nerve.
In order to measure the peripapillary blood flow a variety of devices using different techniques of flowmetry have been developed. In this study, the reproducibility of the retinal flowmetry measured with the LSFG-NAVI device from Nidek will be investigated. A high reproducibility is crucial for the clinical value of any measuring device.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| open-angle glaucoma | – | Diagnostic Test: LASER SPECKLE FLOWGRAPHYpatients with a diagnosis of open-angle glaucoma, i.e. untreated IOP >21mmHg plus glaucomatous disc changes and/or visual field defects typical for glaucoma |
| normal tension glaucoma | – | Diagnostic Test: LASER SPECKLE FLOWGRAPHYpatients with a diagnosis of normal tension glaucoma, i.e. untreated IOP </=21mmHg plus glaucomatous disc changes and/or visual field defects typical for glaucoma |
| healthy controls | – | Diagnostic Test: LASER SPECKLE FLOWGRAPHYindividuals with normal optic disc and IOP </21mmHg and normal visual fields |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 3 groups as described above will be recruted from the outpatient department of the Ophthalmology Department at the UniversityHospital Zurich, Zurich, Switzerland and the Ophthalmology Department at the Cantonal Hospital Aarau, Aarau, Switzerland
Key inclusion criteria (3 listed)
- signed Patient Informed Consent form
- Be at least 18 years old
- Diagnosis of primary or secondary open-angle glaucoma or normal tension glaucoma or healthy controls
Key exclusion criteria (3 listed)
- Age < 18 years
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- No vulnerable participants will be included in this study.
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 |
|---|---|---|
| LASER SPECKLE FLOWGRAPHYNon-invasive, real-time imaging and measurement of ocular blood flow of the optic disc and peripapillary region | Diagnostic test | healthy controls, normal tension glaucoma, open-angle glaucoma |
Primary outcome
Coefficients of variation (COV)
Time frame: 1 month
COVs from 3 measurements of ocular blood flow at visit 1 of observer 1 and at visit 1 of observer 1 and from observer 2 will be computed.
intraclass correlation coefficients (ICCs)
Time frame: 1 month
Intraobserver ICC, interobserver ICC, and inter-session ICC will be computed
4 secondary outcomes
Cofounder
Time frame: 1 month
Cofounder
Time frame: 1 month
Cofounder
Time frame: 1 month
Cofounder
Time frame: 1 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 5 Jun 2023.
- 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.
Marc Töteberg-Harms, MD, FEBO principal investigator
UniversityHospital Zurich, Department of Ophthalmology, Zurich, Switzerland
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 Open Angle Glaucoma and Normal Tension Glaucoma, run by University of Zurich at 1 site in Switzerland.
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 3 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 5 Jun 2023. 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 Switzerland. 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?
Coefficients of variation (COV) (time frame: 1 month). 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 5 Jun 2023.