Primary Open-angle GlaucomaSTAR-VINCT05432245
MINIject Implantation Combined With Cataract Surgery in Patients With POAG and Cataract
A study testing Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS) in people with Primary Open-angle Glaucoma and Cataract, run by iSTAR Medical at 4 sites in 3 countries.
Trial summary
The study will assess safety and performance of MINIject implant in patients with open-angle glaucoma uncontrolled by topical hypotensive medications in conjunction with cataract surgery. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Primary Open-angle Glaucoma, Cataract
- What is being tested?
- Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 18 Jan 2023to Jul 2025
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary open angle glaucoma (POAG) in the study eye
- Operable age-related cataract eligible for phacoemulsification surgery with Intraocular Lens (IOL) implantation
- Glaucoma not adequately controlled with at least one topical hypotensive medication(s), unless the patient has an allergy / intolerance to a medication
- Patient must provide written informed consent to participate
Who cannot join
- Known or suspected allergy or hypersensitivity to medical silicone
- Allergy to fluorescein
- Presence of silicone oil in the study eye
- Individuals under tutorship or trusteeship
- Patient has a condition such that his / her ability to provide personal informed consent is compromised
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
United Kingdom2 sites
East Suffolk and North Essex NHS Foundation Trust - Colchester General Hospital
Colchester, Essex
Princess Alexandra Eye Pavilion
Edinburgh
About this study
Official title: A Prospective, Open, Multicenter Clinical Trial Evaluating the Efficacy and Safety of MINIject Combined With Cataract Surgery in Patients With POAG Uncontrolled by Topical Hypotensive Medications and Operable Age-related Cataract Diagnosis
The study will assess safety and performance of MINIject implant in patients with open-angle glaucoma uncontrolled by topical hypotensive medications in conjunction with cataract surgery.
Read the detailed description
The study aims to evaluate the safety and efficacy of the MINIject in the reduction of intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG) in conjunction with cataract surgery. The cataract surgery will be performed first and if successful, only then will the MINIject be placed.
Patients will be followed for 2 years after the date of their implantation. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination, ocular imaging, assessment of any untoward ocular events etc. will be performed.
- Conditions
- Primary Open-angle Glaucoma, Cataract
- Being tested
- Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS)
- Keywords
- Primary Open-angle Glaucoma (POAG), Cataract, Intra Ocular Pressure (IOP) reduction, Glaucoma Drainage Device, Minimally Invasive Glaucoma Surgery (MIGS), Supraciliary space, Combined procedure (POAG and phacoemulsification)
- Medical subject headings
- Glaucoma, Open-Angle, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS)Device
The cataract surgery will be performed first and if successful, only then will the MINIject be placed into supraciliary space.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Device: Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP
Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP from baseline to 6 months follow-up, with or without IOP lowering medications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start18 Jan 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iSTAR Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zubair Hussain, PhD, Study director, iSTAR Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432245
- Sponsor's protocol ID
- STAR VI
- Acronym
- STAR-VI
- Status last verified
- Feb 2025
- First submitted
- 16 Jun 2022
- Last updated
- 28 Feb 2025
- 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 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Multicenter Clinical Trial Evaluating the Efficacy and Safety of MINIject Combined With Cataract Surgery in Patients With POAG Uncontrolled by Topical Hypotensive Medications and Operable Age-related Cataract Diagnosis
- ClinicalTrials.gov ID
- NCT05432245
- Acronym / sponsor ID
- STAR-VI / STAR VI
- Conditions
- Primary Open-angle Glaucoma, Cataract
- Keywords
- Primary Open-angle Glaucoma (POAG), Cataract, Intra Ocular Pressure (IOP) reduction, Glaucoma Drainage Device, Minimally Invasive Glaucoma Surgery (MIGS), Supraciliary space, Combined procedure (POAG and phacoemulsification)
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- iSTAR MedicalIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 27 Jun 2022 (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 study will assess safety and performance of MINIject implant in patients with open-angle glaucoma uncontrolled by topical hypotensive medications in conjunction with cataract surgery.
Detailed description
The study aims to evaluate the safety and efficacy of the MINIject in the reduction of intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG) in conjunction with cataract surgery. The cataract surgery will be performed first and if successful, only then will the MINIject be placed.
Patients will be followed for 2 years after the date of their implantation. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination, ocular imaging, assessment of any untoward ocular events etc. will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of primary open angle glaucoma (POAG) in the study eye
- Operable age-related cataract eligible for phacoemulsification surgery with Intraocular Lens (IOL) implantation
- Glaucoma not adequately controlled with at least one topical hypotensive medication(s), unless the patient has an allergy / intolerance to a medication
- Patient must provide written informed consent to participate
Key exclusion criteria (5 listed)
- Known or suspected allergy or hypersensitivity to medical silicone
- Allergy to fluorescein
- Presence of silicone oil in the study eye
- Individuals under tutorship or trusteeship
- Patient has a condition such that his / her ability to provide personal informed consent is compromised
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 |
|---|---|---|
| Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS)The cataract surgery will be performed first and if successful, only then will the MINIject be placed into supraciliary space. | Device | Treatment group |
Primary outcome
Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP
Time frame: 6 months
Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP from baseline to 6 months follow-up, with or without IOP lowering medications
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 28 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Zubair Hussain, PhD study director
iSTAR Medical
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS) in people with Primary Open-angle Glaucoma and Cataract, run by iSTAR Medical at 4 sites in 3 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 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: enrolling by invitation, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Panama, 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?
Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP (time frame: 6 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 28 Feb 2025.