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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT03624699
Study type Interventional
Source Swiss Vision Network
Contact
Status Completed
Phase N/A
Start date April 25, 2018
Completion date June 30, 2020

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