Mean Blur RatioNCT03921372
Isometric Exercise in NTG
A study testing Isometric exercise in people with Mean Blur Ratio, run by Augenabteilung Allgemeines Krankenhaus Linz at 1 site in Austria.
Trial summary
Glaucoma is the second leading cause of blindness worldwide. Literature shows increasing evidence that dysfunction of ocular microcirculation in the optic nerve influences the progression of glaucoma. It has been shown that flicker light-induced vasodilatation of retinal veins is diminished in patients with glaucoma. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mean Blur Ratio
- What is being tested?
- Isometric exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustria
- Study dates
- 26 Jul 2018to 25 Feb 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- a) Study population: patients with normal tension glaucoma
- History of ocular or systemic disease causing optic nerve damage
- History of IOP greater than 21 mm Hg (corrected by CCT)
- Participation in a clinical trial in the 3 weeks preceding the study
- Ocular surgery (including intravitreal injection) during the 3 months preceding the study
- Ametropia > 6 Dpt
Show all 29Show fewer
- Smoking
- pre- or perimenopausal women
- Relevant ophthalmic diseases/conditions that could interfere with LSFG measurements (e.g. optic nerve head drusen, tilted disc, etc.)
- Opacities of the cornea (e.g. corneal scars, corneal oedema), the lens (e.g. LOCS-II grading > 2, posterior capsule opacification) or the vitreous (e.g. vitreous haemorrhage, asteroid hyalosis)
- Patients who are not able to cooperate or with insufficient ability to fixate (tremor, nystagmus)
- Blood donation in the 3 weeks preceding the study
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Ocular infection or clinically significant inflammation
- Pregnancy, planned pregnancy or lactating
- Control group
- Abnormal RNFL
- Visual field defects
- Participation in a clinical trial in the 3 weeks preceding the study
- Ocular surgery (including intravitreal injection) during the 3 months preceding the study
- Ametropia > 6 Dpt
- Smoking
- Relevant ophthalmic diseases/conditions that could interfere with LSFG measurements (e.g. optic nerve head drusen, tilted disc, etc.)
- Opacities of the cornea (e.g. corneal scars, corneal oedema), the lens (e.g. LOCS-II grading > 2, posterior capsule opacification) or the vitreous (e.g. vitreous haemorrhage, asteroid hyalosis)
- Patients who are not able to cooperate or with insufficient ability to fixate (tremor, nystagmus)
- Blood donation in the 3 weeks preceding the study
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Ocular infection or clinically significant inflammation
- Pregnancy, planned pregnancy or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optic Nerve Head Blood Flow Regulation During Isometric Exercise in Patients With Normal Tension Glaucoma
Glaucoma is the second leading cause of blindness worldwide. Literature shows increasing evidence that dysfunction of ocular microcirculation in the optic nerve influences the progression of glaucoma. It has been shown that flicker light-induced vasodilatation of retinal veins is diminished in patients with glaucoma. Also previous studies indicate that the blood flow autoregulation is impaired in patients with glaucoma. Therefor the ocular perfusion pressure can not be maintained stable during changes of the systemic arterial blood pressure. Laser speckle flowgraphy (LSFG) represents a non-invasive method to quantify ocular perfusion also at the ONH. LSFG enables noninvasive quantification of microcirculation of the optic disc in Japanese glaucoma patients.
Study Objectives:
To assess the changes in LSFG parameters in patients with normal tension glaucoma, compared to healthy subjects during flicker light stimulation and isometric exercises.
- Conditions
- Mean Blur Ratio
- Being tested
- Isometric exercise
- Keywords
- Normal tension glaucoma
- Medical subject headings
- Low Tension Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric exerciseDiagnostic test
Squatting for 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| Normal Tension Glaucoma (NTG) | Experimental | Patients with diagnosed NTG Receives: Diagnostic Test: Isometric exercise |
| Healthy Control Subjects | Experimental | Subjects with no sign of glaucoma, Age and sex matched Receives: Diagnostic Test: Isometric exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean blur rate
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start26 Jul 2018
- Primary completion25 Feb 2019
- Study completion25 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mean Blur RatioStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augenabteilung Allgemeines Krankenhaus Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Bolz, Augenabteilung Allgemeines Krankenhaus Linz
- Investigators
- Matthias Bolz, Prof., Principal investigator, Allgemeines Krankenhaus Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921372
- Sponsor's protocol ID
- IsometricProtocol2
- Status last verified
- Apr 2019
- First submitted
- 17 Apr 2019
- Last updated
- 19 Apr 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 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optic Nerve Head Blood Flow Regulation During Isometric Exercise in Patients With Normal Tension Glaucoma
- ClinicalTrials.gov ID
- NCT03921372
- Acronym / sponsor ID
- IsometricProtocol2
- Conditions
- Mean Blur Ratio
- Keywords
- Normal tension glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Augenabteilung Allgemeines Krankenhaus LinzUniversity, hospital or other
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 25 Feb 2019 (actual)
- Study completion
- 25 Feb 2019 (actual)
- First posted
- 19 Apr 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.
Glaucoma is the second leading cause of blindness worldwide. Literature shows increasing evidence that dysfunction of ocular microcirculation in the optic nerve influences the progression of glaucoma. It has been shown that flicker light-induced vasodilatation of retinal veins is diminished in patients with glaucoma. Also previous studies indicate that the blood flow autoregulation is impaired in patients with glaucoma. Therefor the ocular perfusion pressure can not be maintained stable during changes of the systemic arterial blood pressure. Laser speckle flowgraphy (LSFG) represents a non-invasive method to quantify ocular perfusion also at the ONH. LSFG enables noninvasive quantification of microcirculation of the optic disc in Japanese glaucoma patients.
Study Objectives:
To assess the changes in LSFG parameters in patients with normal tension glaucoma, compared to healthy subjects during flicker light stimulation and isometric exercises.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Tension Glaucoma (NTG) | Experimental | Diagnostic Test: Isometric exercisePatients with diagnosed NTG |
| Healthy Control Subjects | Experimental | Diagnostic Test: Isometric exerciseSubjects with no sign of glaucoma, Age and sex matched |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (29 listed)
- a) Study population: patients with normal tension glaucoma
- History of ocular or systemic disease causing optic nerve damage
- History of IOP greater than 21 mm Hg (corrected by CCT)
- Participation in a clinical trial in the 3 weeks preceding the study
- Ocular surgery (including intravitreal injection) during the 3 months preceding the 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 |
|---|---|---|
| Isometric exerciseSquatting for 5 minutes | Diagnostic test | Healthy Control Subjects, Normal Tension Glaucoma (NTG) |
Primary outcome
Change in mean blur rate
Time frame: 5 minutes
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 19 Apr 2019.
- Individual participant dataSharing planned: No
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.
Matthias Bolz, Prof. principal investigator
Allgemeines Krankenhaus Linz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isometric exercise in people with Mean Blur Ratio, run by Augenabteilung Allgemeines Krankenhaus Linz 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 0 inclusion and 29 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 19 Apr 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 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?
Change in mean blur rate (time frame: 5 minutes). 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 19 Apr 2019; AzTrials last refreshed its copy on 27 Oct 2026.