GlaucomaNCT04541524
Vienna Preserflo Cohort Study
An observational study of Glaucoma and Glaucoma Surgery, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The Vienna Preserflo Microshunt Cohort Study is an observational study with a prospective postoperative examination in all glaucoma patients who had received a Preserflo Microshunt (PMS) as standalone procedure or in combination with cataract extraction in the time period between January and November 2019 at the… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Glaucoma, Glaucoma Surgery, Post-Op Complication
- What is being tested?
- Santen Preserflo Microshunt
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteAustria
- Study dates
- 5 Jun 2020to 30 Nov 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 to 95 years
- All sexes
- Adult, Older adult
Study population: Glaucoma patients who received a PMS as stndalone procedure or in combination with a cataract surgery in the time period between January and November 2019 at the Department of Ophthalmology, Medical University of Vienna, Austria, will be invited
Who may be able to join
- Glaucoma patients who received a PMS in the time period between January and November 2019 at the Department of Ophthalmology, Medical University of Vienna, Austria, will be invited
Who cannot join
- Unwilling or unable to give informed consent.
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Insitute of Ophthalmology and Optometry, Medical University of Vienna
Vienna, 1090
Clemens Vass, Prof, 40400 - 79400, clemens.vass@meduniwien.ac.at
About this study
Official title: Vienna Preserflo Microshunt Cohort Study
The Vienna Preserflo Microshunt Cohort Study is an observational study with a prospective postoperative examination in all glaucoma patients who had received a Preserflo Microshunt (PMS) as standalone procedure or in combination with cataract extraction in the time period between January and November 2019 at the Department of Ophthalmology, Medical University of Vienna. It is estimated that approximately 70 patients will be included of this cohort. The cohort will be invited for a prospective postoperative examination after 12 (±5) months of follow up. This examination shall comprise best corrected visual acuity, visual field test, intraocular pressure (IOP) measurement, slit lamp examination, fundus examination (optic disc and retina), gonioscopic assessment of PMS position, anterior segment optical coherence tomography (OCT) (shunt position, anterior chamber angle assessment, limbus shape analysis), corneal pachymetry, specular microscopy of corneal endothelial cells. Additionally, retrospective information concerning IOP, medication and visual fields of all patients will be collected from the Department of Ophthalmology as well as from the referring ophthalmologists where possible. Additionally, we will perform a comparison between two groups to compare differences in outcome measures.
Read the detailed description
During the inclusion period two slightly different surgical approaches have been used. At the beginning of the surgery, the conjunctiva is opened and the Tenon capsule is getting dissected from the sclera. In the first group of patients (group 1) we made a fornix based conjunctival opening, prepared a 1mm wide and long scleral pocket in 3mm distance from limbus and placed the PMS in the anterior chamber via a 25G needle track. In the second group (group 2) the conjunctival opening was 3.5 mm from the limbus, the scleral pocket was prepared at 3.5 mm distance from the limbus and a 27G needle was used. The outcomes of these two groups will be compared.
- Conditions
- Glaucoma, Glaucoma Surgery, Post-Op Complication, Efficacy, Self, Safety Issues
- Being tested
- Santen Preserflo Microshunt
- Medical subject headings
- Glaucoma, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Santen Preserflo MicroshuntDevice
The PMS is 8.5 mm long has an outer diameter of 350 μm and a lumen diameter of 70 μm. It has a fin sized 1.1 mm located 4.5 mm distally from the internal tip of the device and it consists of poly(styrene-b-isobutylene-b-styrene) SIBS. The device was implanted 1 year prior to the present study via an ab externo approach. At the beginning of the surgery, the conjunctiva was opened. In the first group of patients (group 1) we made a fornix based conjunctival opening, prepared a 1mm wide and long scleral pocket in 3mm distance from limbus and placed the PMS in the anterior chamber via a 25G needle track. In the second group (group 2) the conjunctival opening was 3.5 mm from the limbus, the scleral pocket was prepared at 3.5 mm distance from the limbus and a 27G needle was used. PMS guides aqueous humor from the anterior chamber to the subconjunctival space. The forming filtering bleb absorbs aqueous humor which leads to IOP reduction.
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP
IOP in mmHg
Measured: one year
Full success
IOP below 21 and IOP reduction of at least 20% from baseline without medication
Measured: one year
Qualified success
IOP below 21 and IOP reduction of at least 20% from baseline with or without medication
Measured: one year
Complications
Number of complications per eye
Measured: one year
Secondary outcomes (7)
Re-intervention rate rate
Proportion of eyes requiring either needling revision of filtering bleb revision or any other glaucoma surgery
Measured: one year
Medication rate
Number of patients who needed again eye pressure lowering medication
Measured: one year
Average medication
Average number of different eye pressure lowering medication
Measured: one year
OCT - shunt entry
Shunt position in chamber angle as determined by anterior segment OCT
Measured: one year
OCT - shunt clearance
Shunt-cornea angle as determined by anterior segment OCT
Measured: one year
OCT - shunt length
Shunt length in the anterior chamber as determined by anterior segment OCT
Measured: one year
Corneal endothelial cell count
Corneal endothelial cell count in specular microscopy of corneal endothelium
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start5 Jun 2020
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clemens Vass, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541524
- Sponsor's protocol ID
- 1142_2020
- Status last verified
- Sep 2020
- First submitted
- 17 Jul 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vienna Preserflo Microshunt Cohort Study
- ClinicalTrials.gov ID
- NCT04541524
- Acronym / sponsor ID
- 1142_2020
- Conditions
- Glaucoma, Glaucoma Surgery, Post-Op Complication, Efficacy, Self, Safety Issues
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 9 Sep 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 Vienna Preserflo Microshunt Cohort Study is an observational study with a prospective postoperative examination in all glaucoma patients who had received a Preserflo Microshunt (PMS) as standalone procedure or in combination with cataract extraction in the time period between January and November 2019 at the Department of Ophthalmology, Medical University of Vienna. It is estimated that approximately 70 patients will be included of this cohort. The cohort will be invited for a prospective postoperative examination after 12 (±5) months of follow up. This examination shall comprise best corrected visual acuity, visual field test, intraocular pressure (IOP) measurement, slit lamp examination, fundus examination (optic disc and retina), gonioscopic assessment of PMS position, anterior segment optical coherence tomography (OCT) (shunt position, anterior chamber angle assessment, limbus shape analysis), corneal pachymetry, specular microscopy of corneal endothelial cells. Additionally, retrospective information concerning IOP, medication and visual fields of all patients will be collected from the Department of Ophthalmology as well as from the referring ophthalmologists where possible. Additionally, we will perform a comparison between two groups to compare differences in outcome measures.
Detailed description
During the inclusion period two slightly different surgical approaches have been used. At the beginning of the surgery, the conjunctiva is opened and the Tenon capsule is getting dissected from the sclera. In the first group of patients (group 1) we made a fornix based conjunctival opening, prepared a 1mm wide and long scleral pocket in 3mm distance from limbus and placed the PMS in the anterior chamber via a 25G needle track. In the second group (group 2) the conjunctival opening was 3.5 mm from the limbus, the scleral pocket was prepared at 3.5 mm distance from the limbus and a 27G needle was used. The outcomes of these two groups will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Glaucoma patients who received a PMS as stndalone procedure or in combination with a cataract surgery in the time period between January and November 2019 at the Department of Ophthalmology, Medical University of Vienna, Austria, will be invited
Key inclusion criteria (1 listed)
- Glaucoma patients who received a PMS in the time period between January and November 2019 at the Department of Ophthalmology, Medical University of Vienna, Austria, will be invited
Key exclusion criteria (2 listed)
- Unwilling or unable to give informed consent.
- Pregnancy or lactation
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 |
|---|---|---|
| Santen Preserflo MicroshuntThe PMS is 8.5 mm long has an outer diameter of 350 μm and a lumen diameter of 70 μm. It has a fin sized 1.1 mm located 4.5 mm distally from the internal tip of the device and it consists of poly(styrene-b-isobutylene-b-styrene) SIBS. The device was implanted 1 year prior to the present study via an ab externo approach. At the beginning of the surgery, the conjunctiva was opened. In the first group of patients (group 1) we made a fornix based conjunctival opening, prepared a 1mm wide and long scleral pocket in 3mm distance from limbus and placed the PMS in the anterior chamber via a 25G needle track. In the second group (group 2) the conjunctival opening was 3.5 mm from the limbus, the scleral pocket was prepared at 3.5 mm distance from the limbus and a 27G needle was used. PMS guides aqueous humor from the anterior chamber to the subconjunctival space. The forming filtering bleb absorbs aqueous humor which leads to IOP reduction. | Device | – |
Primary outcome
IOP
Time frame: one year
IOP in mmHg
Full success
Time frame: one year
IOP below 21 and IOP reduction of at least 20% from baseline without medication
Qualified success
Time frame: one year
IOP below 21 and IOP reduction of at least 20% from baseline with or without medication
Complications
Time frame: one year
Number of complications per eye
7 secondary outcomes
Re-intervention rate rate
Time frame: one year
Medication rate
Time frame: one year
Average medication
Time frame: one year
OCT - shunt entry
Time frame: one year
OCT - shunt clearance
Time frame: one year
OCT - shunt length
Time frame: one year
Corneal endothelial cell count
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
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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?
An observational study of Glaucoma and Glaucoma Surgery, 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 1 inclusion and 2 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 9 Sep 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 Clemens Vass, Univ.Prof (0043140400 ext. 79400, clemens.vass@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP (time frame: one year). The study lists 4 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 9 Sep 2020.