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In this prospective 24-month single study assesses the safety and efficacy of OMNI720 Surgical System as a Standalone Procedure. The drug consumption, intraocular pressure and secondary surgical procedures required to control intraocular pressure are analyzed during the follow-up of at least 24 months after the OMNI procedure period.
In this data collection were recorded Ocular Medical Assessment, BCVA, Slit LampExam, IOPvia Applanation Tonometry, Gonioscopy, Fundus Exam, Nerve Abnormality Assessment, Optic Nerve Head Imaging, C/D Ratio, Visual Field Pachymetry and Endothelial cell morphology. Screening visit, subsequent wash-out phase (1d-48d) and baseline (IOP [9: 00; 12: 00; 15: 00]) before surgery. Follow-up visits 1 day, 1 week, 1 month, 3 month,6 month, 9 months, 12 months, 18 months , 18 months and 24 months after surgery are planned.
Currently we have investigated 20 patients in a period of 6 months after surgery. We have a constant BCVA and the medication has been reduced by about 80%. The IOD (baseline) without medication has fallen by half on average. The complications were hyphema, tyndal cells and hyphosphagma.
On the results after six month, the IOP decline and the reduction of the drug is a success. For a long-term evaluation or recommendation more and especially longer data are necessary
This presentation is from the session "SPS-105 Minimally Invasive Glaucoma Surgery: Viscocanalostomy, Combined Procedures, Outcomes" from the 2020 ASCRS Virtual Annual Meeting held on May 16-17, 2020.