Open Angle GlaucomaNCT02825264
STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program
An observational study of Open Angle Glaucoma, run by iSTAR Medical at 9 sites in 5 countries.
Trial summary
STARflo is a novel suprachoroidal Glaucoma Drainage Device (GDD), bleb-free, exhibiting anti-fibrotic properties. Release of this CE Marked implant has been limited to leading Glaucoma Centers in Europe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- STARflo Implant
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Jul 2016to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients suffering from open angle glaucoma or some case of narrow angle glaucoma who have been implanted with STARflo.
Who may be able to join
- Patients suffering from open angle glaucoma or some case of narrow angle glaucoma who have been implanted with STARflo implant from 2011
- Patients who have signed a Data Release form
Who cannot join
- Patients who did not sign a Data Release form
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Germany4 sites
St. Johannes Hospital Dortmund
Dortmund, 44137
Universitäts-Augenklinik Heidelberg
Heidelberg, 69120
Klinikum der Universität München
München, 81377
Augenklinik Universitätsmedizin Rostock
Rostock, 18057
France2 sites
Hospital de la Croix-Rousse
Lyon, 69317
CHNO des Quinze-Vingts
Paris, 75571
About this study
Official title: STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program in a Real-World Patient Population
STARflo is a novel suprachoroidal Glaucoma Drainage Device (GDD), bleb-free, exhibiting anti-fibrotic properties. Release of this CE Marked implant has been limited to leading Glaucoma Centers in Europe.
Read the detailed description
This Clinical Experience Program is being initiated to expand the surgical and clinical practice knowledge about the use of STARflo for reducing intraocular pression (IOP) in patients suffering from open angle glaucoma in a real world population of patients.
This program is designed to be an international multicenter observational study.
Patient data may be collected retrospectively and/or prospectively for up to 5 years after surgery.
The aim of this program is to document the patient's benefit following implantation of the STARflo implant in a real-word patient population, to learn about surgical practices and to collect data to support future cost-effectiveness analysis.
- Conditions
- Open Angle Glaucoma
- Being tested
- STARflo Implant
- Keywords
- Glaucoma Drainage Device, STARflo
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STARflo ImplantDevice
All patients who have been implanted with STARflo implant from 2011 will be offered to participate to this data collection
| Study group | Role | What they receive |
|---|---|---|
| STARflo | Patients who have been implanted with STARflo implant Receives: Device: STARflo Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of intraocular pressure (IOP)
IOP reduction compared after 12 months compared to baseline IOP
Measured: at 12 Months
Secondary outcomes (3)
Occurence of Ocular Adverse Events
to record and document all complications and Adverse Events/Adverse Device Effects occurred during and after surgery
Measured: up to 60 Months after surgery
Reduction of intraocular pressure (IOP) over time
IOP reduction compared after 6, 24, 36, 48 and 60 months compared to baseline IOP
Measured: at 6, 24, 36, 48 and 60 Months
Reduction of IOP lowering medication
Reduction of IOP lowering medication intake compare to baseline
Measured: at 6, 12, 24, 36, 48 and 60 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
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.
- 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
- Other
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- iSTAR Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zubair Hussain, PhD, Study director, Sponsor Representative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825264
- Sponsor's protocol ID
- ISM03
- Status last verified
- Aug 2022
- First submitted
- 20 Jun 2016
- Last updated
- 9 Aug 2022
- 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 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STAR-LIFE Registry: STARflo Glaucoma Implant Clinical Experience Program in a Real-World Patient Population
- ClinicalTrials.gov ID
- NCT02825264
- Acronym / sponsor ID
- ISM03
- Conditions
- Open Angle Glaucoma
- Keywords
- Glaucoma Drainage Device, STARflo
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- iSTAR MedicalIndustry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Jul 2016 (estimated)
- 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.
STARflo is a novel suprachoroidal Glaucoma Drainage Device (GDD), bleb-free, exhibiting anti-fibrotic properties. Release of this CE Marked implant has been limited to leading Glaucoma Centers in Europe.
Detailed description
This Clinical Experience Program is being initiated to expand the surgical and clinical practice knowledge about the use of STARflo for reducing intraocular pression (IOP) in patients suffering from open angle glaucoma in a real world population of patients.
This program is designed to be an international multicenter observational study.
Patient data may be collected retrospectively and/or prospectively for up to 5 years after surgery.
The aim of this program is to document the patient's benefit following implantation of the STARflo implant in a real-word patient population, to learn about surgical practices and to collect data to support future cost-effectiveness analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STARflo | – | Device: STARflo ImplantPatients who have been implanted with STARflo implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from open angle glaucoma or some case of narrow angle glaucoma who have been implanted with STARflo.
Key inclusion criteria (2 listed)
- Patients suffering from open angle glaucoma or some case of narrow angle glaucoma who have been implanted with STARflo implant from 2011
- Patients who have signed a Data Release form
Key exclusion criteria (1 listed)
- Patients who did not sign a Data Release form
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 |
|---|---|---|
| STARflo ImplantAll patients who have been implanted with STARflo implant from 2011 will be offered to participate to this data collection | Device | STARflo |
Primary outcome
Reduction of intraocular pressure (IOP)
Time frame: at 12 Months
IOP reduction compared after 12 months compared to baseline IOP
3 secondary outcomes
Occurence of Ocular Adverse Events
Time frame: up to 60 Months after surgery
Reduction of intraocular pressure (IOP) over time
Time frame: at 6, 24, 36, 48 and 60 Months
Reduction of IOP lowering medication
Time frame: at 6, 12, 24, 36, 48 and 60 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
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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.
Zubair Hussain, PhD study director
Sponsor Representative
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Angle Glaucoma, run by iSTAR Medical at 9 sites in 5 countries.
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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, France, Belgium, Hungary, Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Reduction of intraocular pressure (IOP) (time frame: at 12 Months). 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 Aug 2022.