Study Details
Testing the Medical Device PRESFLO® Microshunt for People with Primary Open-Angle Glaucoma who have Failed Previous Medical and Surgical Treatment
(IRB#: IRB_00184386)
Open-Angle Glaucoma is a condition when pressure inside your eye (eye pressure) is too high causing damage to the optic nerve and/or decrease the visual field and even vision loss. The optic nerve transmits the images you see to your brain. Visual field is a measurement of a persons range of vision, from narrow to wide. This study will test a medical device called PRESERFLO® Microshunt to treat people with the condition. The study wants to see if the medical device will help people with the condition and is safe. People in this study will have the medical device surgically implanted into the eye. Being in the study requires participating for at least 1 year, some may be asked to attend annual study visits up to 5 years. Medical tests will be done during the study to track the health of participants.
- All genders
- Over 18 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Over 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 45 years and older
- Diagnosis of Primary Open-Glaucoma
- Glaucomatous visual field defects consistent with optic nerve defects with specific criteria
- Nerve abnormality characteristic of Glaucoma
- Cognitive awareness for full study participation
Exclusion Criteria
- Other specific Glaucoma types
- Prior Glaucoma surgeries within 90 days before participation
- Eyes with a history of complicated cataract surgeries, or have anterior chamber, or implantable contact lenses
- Any prior intraocular (artificial lens) surgeries (excluding phacoemulsification, a cataract surgery) within 90 days of screening
- Pregnant or breastfeeding
Will I be paid for my time?
Yes
IRB#: IRB_00184386
PI: Iqbal Ahmed
Department: OPHTHALMOLOGY-CLINICAL STUDIES
Approval Date: 2025-06-18 06:00:00
Study Categories: Studies Related to the Eye
Specialties: Ophthalmology
I am Interested