Evaluate the Safety and Effectiveness of iSTAR Medical's MINIject™ Implant for Lowering Intraocular Pressure (IOP) in Subjects With Primary Open-angle Glaucoma.
This research study is looking at a new small device called the MINIject™ implant, made by iSTAR Medical. Its main job is to help reduce the pressure inside the eye for people who have primary open-angle glaucoma. This type of glaucoma is a common eye condition that can damage your sight if left untreated. The study wants to find out two key things: first, how safe the implant is, and second, how effective it is at lowering eye pressure. Participants in the study are aged 46 or older. By testing this new implant, doctors hope to find a better way to manage glaucoma and protect people's vision from further harm. This study will involve people from several different medical centres.
At a glance
What is this study about?
This study is about a medical device called the MINIject™ implant. It's a tiny implant, and it's being tested to see if it can help people with a common eye condition called primary open-angle glaucoma. Glaucoma happens when the pressure inside your eye gets too high, which can slowly damage the nerve that connects your eye to your brain. If this damage continues, it can lead to vision loss.
The main goal of this particular study is to check two important things: first, how safe the MINIject™ implant is when it's put into the eye; and second, how well it works at bringing down and keeping eye pressure at a healthy level. By reducing eye pressure, doctors hope to prevent further damage to the optic nerve and help preserve your vision. This research is important because it could lead to new ways to treat glaucoma more effectively in the future.
This is a careful study where doctors and researchers will be closely watching how the implant works in real patients. They are looking for scientific evidence to show that this new implant is a good and safe option for people living with glaucoma.
Key takeaways
- This study evaluates a new implant for glaucoma, not a medicine.
- It aims to lower eye pressure in people with a common type of glaucoma.
- Participants must be aged 46 or older and have had previous cataract surgery.
- The study assesses both the safety and effectiveness of the implant.
- Participation involves eye examinations and follow-up after the implant procedure.
Who may be eligible?
To be able to join this study, you would generally need to be a man or woman who is 46 years old or older. You must have been diagnosed with a specific type of glaucoma called primary open-angle glaucoma. This means you have glaucoma and your doctor has discussed treatments with you, such as eye drops, laser treatment, or even surgery.
Another important point is that you must have already had cataract surgery in the eye being studied, and that surgery should have been straightforward and without complications. This means your eye already has an artificial lens.
There are also some reasons why you might not be able to join. For example, if you have other types of glaucoma like angle-closure, congenital (from birth), or secondary glaucoma. You also can't have other serious eye conditions that affect your vision, or any current infection or inflammation in your eye.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Am I 46 years old or older?
- Have I been diagnosed with primary open-angle glaucoma?
- Has my doctor discussed glaucoma treatments like drops, laser, or surgery with me?
- Have I already had cataract surgery in the eye being studied, and it went well?
- Do I currently have any eye infections or inflammation?
What does participation involve?
Taking part in this study would involve several visits to the clinic over time. During these visits, doctors and nurses will carry out various examinations to check your eye health, measure your eye pressure, and see how the implant is working. They will also ask you about your vision and any symptoms you might have. You might need to have your vision tested, and your eyes checked using special equipment.
The MINIject™ implant is a device that would be placed in your eye during a small surgical procedure. After the procedure, there will be a follow-up period where your eye will be monitored regularly. You might be asked to use eye drops or other medications as directed by the study doctors. The total time you would be involved in the study will depend on the study design, but generally, clinical trials involve monitoring for months, or sometimes even longer, to properly assess the effects of a new treatment. All these steps are important to make sure the implant is safe and effective.
Potential risks and benefits
Locations (37)
- Arizona Advanced Eye Research InstituteVerified postcodeGlendale, United States
- Vold VisionVerified postcodeFayetteville, United States
- Beverly Hills Institute of OphthalmologyVerified postcodeBeverly Hills, United States
- Reeve Woods Eye CenterVerified postcodeChico, United States
- Sacramento Eye Consultants, A Medical CorporationVerified postcodeSacramento, United States
- Grand Junction Eye CareVerified postcodeGrand Junction, United States
- Eye Associates of Fort MyersVerified postcodeFort Myers, United States
- Intermountain Eye CenterVerified postcodeEagle, United States
- Illinois Eye CenterVerified postcodePeoria, United States
- Virdi Eye ClinicVerified postcodeRock Island, United States
- Stiles Eyecare Excellene and Glaucoma InstituteVerified postcodeOverland Park, United States
- LA Eye and LaserVerified postcodeAlexandria, United States
Common questions
What is glaucoma?
Glaucoma is an eye condition where the pressure inside your eye becomes too high, which can damage the nerve connecting your eye to your brain and lead to vision loss.
What is the MINIject™ implant?
It's a tiny device being tested to see if it can help lower the pressure inside the eye for people with glaucoma.
Who can join this study?
Generally, men and women aged 46 or older with a specific type of glaucoma who have already had cataract surgery in the study eye.
Will I get paid to be in the study?
The study does not mention payment, but sometimes travel expenses can be reimbursed. You should ask the study team about this.
Can I stop being in the study at any time?
Yes, you are free to leave the study at any point without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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