The aim of this study is to evaluate the safety and intraocular pressure (IOP) lowering effect of two iStent inject devices in combination with cataract surgery in patients with mild-to-moderate open-angle glaucoma.
Patients suffering from open-angle glaucoma who are planning to undergo cataract surgery and are matching the inclusion criteria will be offered to join the study until the desired sample size (50) is reached. Combined cataract-iStent surgery will be performed as per the devices' manufacturers' instructions. Two iStent inject devices will be micro-invasively implanted in the trabecular meshwork of the eye during planned cataract surgery. Six post-operative follow-ups will be carried out over a duration of 12 months, during which various measurements will be made. Performance Outcomes will analyse the proportion of patients with IOP reduction of ≥ 20% vs. baseline mean IOP, at 6 and 12 months. Quality of life outcome will look at the improvement in perceived quality of life as expressed in the NEI VFQ-25 questionnaires from baseline to 3 and 12 months. The rate of adverse events will be recorded.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
iStent inject® Devices Implanted in Combination with Cataract Surgery in Patients with Open-Angle Glaucoma
Glaucoma Research Centre, Montchoisi Clinic
Lausanne, Canton of Vaud, Switzerland
Performance Outcome: IOP reduction
Proportion of patients with IOP reduction of ≥ 20% vs. baseline mean IOP, at 12 months.
Time frame: 12 months
Quality of life: NEI VFQ-25 score
Improvement in perceived quality of life as expressed in the NEI VFQ-25 (National Eye Institute Vision Function) questionnaires from baseline to 12 months.
Time frame: 12 months
Safety Outcome: Adverse events
Rate of adverse events through the follow-up period.
Time frame: 12 months
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