Intraocular PressureNCT04044274
Evaluation of a Novel Method for Increasing Intraocular Pressure in Healthy Subjects
A study testing IOPstim and Suction Cup in people with Intraocular Pressure, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Adequate perfusion is necessary for maintaining tissue function. This applies also for the eye, in which ocular perfusion pressure (OPP) is generally estimated as the difference between mean arterial pressure (MAP) and intraocular pressure (IOP). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- IOPstim and Suction Cup
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteAustria
- Study dates
- 24 Jul 2019to 2 Feb 2021
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged between 18 and 35 years
- Non-smokers
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropia < 1 Dpt.
Who cannot join
- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Treatment in the previous 3 weeks with any drug (except contraceptives)
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Blood donation during the previous 3 weeks
- Pregnancy, planned pregnancy or lactating
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna
About this study
Adequate perfusion is necessary for maintaining tissue function. This applies also for the eye, in which ocular perfusion pressure (OPP) is generally estimated as the difference between mean arterial pressure (MAP) and intraocular pressure (IOP). In the latter formula, IOP substitutes for central retinal venous pressure (CRVP), which is assumed to be slightly higher than IOP to allow blood flow to exit the eye. It has, however, been found that in some patients CRVP is elevated and significantly higher than IOP, which would lead to a decrease in OPP which is not taken in account with the proposed formula. Therefore, techniques for measurement of CRVP are warranted. Recently, a new, method for measurement of this parameter without corneal contact has been introduced. Briefly, with this method, IOP is elevated until the vein collapses, which then equals CRVP. In the present study this technique will be applied in 12 healthy subjects to validate whether the values that are preset by the device correlate to measurements obtained with standard Goldmann applanation tonometry. For this purpose, IOP will be experimentally increased in steps of approximately 5mmHg until it reaches 40mmHg as measured by applanation tonometry. After a resting period of 30 minutes, IOP will be again increased stepwise to 40 mmHg while retinal vessel diameters will be monitored using dynamic vessel analyzer. During this session CRVP will be measured. After another resting period of 30 minutes IOP will be stepwise increased a third time and after each step OCT, OCT-A and OCT EDI will be performed.
- Conditions
- Intraocular Pressure
- Being tested
- IOPstim, Suction Cup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOPstimDevice
IOPstim (IMEDOS, Jena, Germany) is a device exerting defined pressure to the sclera and hence increasing IOP.
Suction CupDevice
Suction Cup is a device exerting defined suction to the clear and hence increasing IOP
| Study group | Role | What they receive |
|---|---|---|
| IOPstim | Experimental | Not described Receives: Device: IOPstim; Device: Suction Cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure (IOP)
Measured: 15 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start24 Jul 2019
- Primary completion2 Feb 2021
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
- Investigators
- Gerhard Garhöfer, MD, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044274
- Sponsor's protocol ID
- OPHT-120219
- Status last verified
- Apr 2022
- First submitted
- 1 Aug 2019
- Last updated
- 7 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Method for Increasing Intraocular Pressure in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04044274
- Acronym / sponsor ID
- OPHT-120219
- Conditions
- Intraocular Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 5 Aug 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.
Adequate perfusion is necessary for maintaining tissue function. This applies also for the eye, in which ocular perfusion pressure (OPP) is generally estimated as the difference between mean arterial pressure (MAP) and intraocular pressure (IOP). In the latter formula, IOP substitutes for central retinal venous pressure (CRVP), which is assumed to be slightly higher than IOP to allow blood flow to exit the eye. It has, however, been found that in some patients CRVP is elevated and significantly higher than IOP, which would lead to a decrease in OPP which is not taken in account with the proposed formula. Therefore, techniques for measurement of CRVP are warranted. Recently, a new, method for measurement of this parameter without corneal contact has been introduced. Briefly, with this method, IOP is elevated until the vein collapses, which then equals CRVP. In the present study this technique will be applied in 12 healthy subjects to validate whether the values that are preset by the device correlate to measurements obtained with standard Goldmann applanation tonometry. For this purpose, IOP will be experimentally increased in steps of approximately 5mmHg until it reaches 40mmHg as measured by applanation tonometry. After a resting period of 30 minutes, IOP will be again increased stepwise to 40 mmHg while retinal vessel diameters will be monitored using dynamic vessel analyzer. During this session CRVP will be measured. After another resting period of 30 minutes IOP will be stepwise increased a third time and after each step OCT, OCT-A and OCT EDI will be performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IOPstim | Experimental | Device: IOPstim, Device: Suction Cup |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men and women aged between 18 and 35 years
- Non-smokers
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropia < 1 Dpt.
Key exclusion criteria (5 listed)
- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Treatment in the previous 3 weeks with any drug (except contraceptives)
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Blood donation during the previous 3 weeks
- Pregnancy, planned pregnancy or lactating
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 |
|---|---|---|
| IOPstimIOPstim (IMEDOS, Jena, Germany) is a device exerting defined pressure to the sclera and hence increasing IOP. | Device | IOPstim |
| Suction CupSuction Cup is a device exerting defined suction to the clear and hence increasing IOP | Device | IOPstim |
Primary outcome
Intraocular pressure (IOP)
Time frame: 15 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 7 Apr 2022.
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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.
Gerhard Garhöfer, MD principal investigator
Department of Clinical Pharmacology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IOPstim and Suction Cup in people with Intraocular Pressure, run by Medical University of Vienna 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 4 inclusion and 5 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 Apr 2022. 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?
Intraocular pressure (IOP) (time frame: 15 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 7 Apr 2022.