Primary Open Angle GlaucomaPAINTNCT04440527
Intraocular Pressure After Preserflo / Innfocus Microshunt Implantation vs Trabeculectomy
A study testing Preserflo / Innfocus Microshunt and Trabeculectomy in people with Primary Open Angle Glaucoma and Pseudoexfoliation Glaucoma, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
The aim of this project is to compare trabeculectomy with Preserflo / Innfocus Microshunt in patients with Primary Angle Open Glaucoma and Pseudoexfoliation Glaucoma regarding the reduction of intraocular pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma
- What is being tested?
- Preserflo / Innfocus Microshunt and Trabeculectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteAustria
- Study dates
- 22 Jul 2020to 22 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Primary open angle glaucoma or pseudoexfoliation glaucoma
- medically uncontrollable intraocular pressure or intolerance of topical therapy
- negative urine/serum pregnancy test of women in childbearing age
- signed and dated informed consent
Who cannot join
- previous incisional glaucoma procedure on affected eye
- pregnancy, nursing period
- Patients in military service, training periods and civil service
- Participation in another clinical trail
- pre-existing ocular pathologies: high myopia (refraction ≥8.00 D), thin conjunctiva
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraocular Pressure After Preserflo /Innfocus Microshunt vs Trabeculectomy: a Prospective, Randomised Control-trial (PAINT-Study)
The aim of this project is to compare trabeculectomy with Preserflo / Innfocus Microshunt in patients with Primary Angle Open Glaucoma and Pseudoexfoliation Glaucoma regarding the reduction of intraocular pressure.
Read the detailed description
The study is a prospective, randomized, monocentric, part blinded, controlled non-inferiority study of glaucoma patients.
- Being tested
- Preserflo / Innfocus Microshunt, Trabeculectomy
- Medical subject headings
- Glaucoma, Open-Angle, Exfoliation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preserflo / Innfocus MicroshuntDevice
The Microshunt features an 8.5-mm tube with an outer diameter of 350 µm and a 70-µm diameter lumen. Implantation creates a subconjunctival bleb and lowers intraocular pressure by increasing aqueous humor outflow.
TrabeculectomyOther
Trabeculectomy is the most commonly performed surgical procedure and is considered the gold standard.
| Study group | Role | What they receive |
|---|---|---|
| Microshunt | Experimental | Patients will be treated with Preserflo / Innfocus Microshunt (Santen Pharmaceutical Co., Ltd.). Receives: Device: Preserflo / Innfocus Microshunt |
| Trabeculectomy | Active comparator | Patients will be treated with trabeculectomy. Receives: Other: Trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in intraocular pressure
The primary endpoint is the difference between intraocular pressure after microshunt implantation vs trabeculectomy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start22 Jul 2020 (estimated)
- Primary completion22 Jul 2022 (estimated)
- Study completion22 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440527
- Sponsor's protocol ID
- PAINT-Study
- Acronym
- PAINT
- Status last verified
- Jun 2020
- First submitted
- 18 Jun 2020
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraocular Pressure After Preserflo /Innfocus Microshunt vs Trabeculectomy: a Prospective, Randomised Control-trial (PAINT-Study)
- ClinicalTrials.gov ID
- NCT04440527
- Acronym / sponsor ID
- PAINT / PAINT-Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 22 Jul 2020 (estimated)
- Primary completion
- 22 Jul 2022 (estimated)
- Study completion
- 22 Jul 2024 (estimated)
- First posted
- 19 Jun 2020 (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.
The aim of this project is to compare trabeculectomy with Preserflo / Innfocus Microshunt in patients with Primary Angle Open Glaucoma and Pseudoexfoliation Glaucoma regarding the reduction of intraocular pressure.
Detailed description
The study is a prospective, randomized, monocentric, part blinded, controlled non-inferiority study of glaucoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microshunt | Experimental | Device: Preserflo / Innfocus MicroshuntPatients will be treated with Preserflo / Innfocus Microshunt (Santen Pharmaceutical Co., Ltd.). |
| Trabeculectomy | Active comparator | Other: TrabeculectomyPatients will be treated with trabeculectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Primary open angle glaucoma or pseudoexfoliation glaucoma
- medically uncontrollable intraocular pressure or intolerance of topical therapy
- negative urine/serum pregnancy test of women in childbearing age
- signed and dated informed consent
Key exclusion criteria (5 listed)
- previous incisional glaucoma procedure on affected eye
- pregnancy, nursing period
- Patients in military service, training periods and civil service
- Participation in another clinical trail
- pre-existing ocular pathologies: high myopia (refraction ≥8.00 D), thin conjunctiva
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 |
|---|---|---|
| Preserflo / Innfocus MicroshuntThe Microshunt features an 8.5-mm tube with an outer diameter of 350 µm and a 70-µm diameter lumen. Implantation creates a subconjunctival bleb and lowers intraocular pressure by increasing aqueous humor outflow. | Device | Microshunt |
| TrabeculectomyTrabeculectomy is the most commonly performed surgical procedure and is considered the gold standard. | Other | Trabeculectomy |
Primary outcome
Difference in intraocular pressure
Time frame: 1 year
The primary endpoint is the difference between intraocular pressure after microshunt implantation vs trabeculectomy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preserflo / Innfocus Microshunt and Trabeculectomy in people with Primary Open Angle Glaucoma and Pseudoexfoliation Glaucoma, run by Medical University Innsbruck 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 5 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: status not confirmed, as of the sponsor's last update on 19 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teresa Rauchegger, Dr. (+43 512 504 24184, teresa.rauchegger@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in intraocular pressure (time frame: 1 year). 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 Jun 2020.