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News
Sight Sciences Announces Substantial Crossover Raise
News
Sight Sciences Announces Positive Interim Clinical Results from Prospective, Multicenter Trial of the OMNI Surgical System in Open Angle Glaucoma
News
Sight Sciences Announces First Patients Enrolled in ORION: A Prospective, Multicenter Clinical Trial of the OMNI Surgical System in Pseudophakic, Mild-to-Moderate Glaucoma Patients
News
Sight Sciences Appoints Donald J. Zurbay to Company’s Board of Directors
February 26, 2020
Retreatment With A Single TearCare™ Treatment Continues To Provide Relief For Patients With Dry Eye Disease

A new, single center, prospective clinical study published in the January issue of Clinical Ophthalmology provides preliminary evidence that retreatment with the Sight Sciences TearCare System is a safe and effective treatment...

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May 02, 2019
Sight Sciences Announces Official Launches of TearCare™ and the Enhanced, Next Generation OMNI™ System

New Dry Eye and MIGS Entrants will be Prominently Featured in Product Demonstrations and Events at Upcoming Industry Shows MENLO PARK, Calif. – Sight Sciences, Inc., a growth-stage medical device...

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    Indications and Safety for OMNI™ Glaucoma Treatment System

    Indications for use

    The OMNI™ Glaucoma Treatment System is indicated for the catheterization and transluminal viscodilation of Schlemm’s canal and the cutting of trabecular meshwork to reduce intraocular pressure in adult patients with open-angle glaucoma.
     

    Disclaimer

    The OMNI™ Glaucoma Treatment System is cleared (indicated) by FDA for the uses set forth above. While the OMNI™ Glaucoma Treatment System is not specifically cleared for transluminal canal dilation, there is support for its use in transluminal canal dilation in the literature and medical textbooks, and ab interno trabeculotomy, for which it is FDA-cleared, is referred to as a MIGS procedure in the literature and medical textbooks and dictionaries. A current list of references/publications is available through Sight Sciences, Inc.

     

    Warnings

    1. Do not use in cases where there is insufficient visualization of the anterior chamber. The following conditions may prohibit sufficient visualization required for safe and successful cannula and microcatheter placement: corneal edema, corneal haze, corneal opacity, or any other conditions that may inhibit surgeon view.

    2. Maintain direct microscopic visualization of the cannula tip and microcatheter tip at all times during the procedure to facilitate advancement and to avoid inadvertently damaging intraocular structures, kinking the microcatheter or unintended tearing of trabecular meshwork.

    3. The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. If intraocular pressure is not adequately maintained after surgery, the surgeon should initiate the appropriate management of intraocular pressure, including medication or surgery.

     

    Potential adverse events

    Adverse events that may be reasonably associated with the use of the OMNI™ System in the eye include but are not limited to the following: anterior chamber shallowing, severe, prolonged, or persistent intraocular inflammation including toxic anterior segment syndrome (TASS), endophthalmitis or other ocular infection, aqueous misdirection, Descemet’s membrane tear or detachment, intracorneal hematoma, choroidal effusion, suprachoroidal hemorrhage, corneal decompensation, corneal injury, corneal edema or opacification, unintended trabeculotomy, cyclodialysis cleft, hyphema, hypopyon, hypotony, hypotony maculopathy, IOL dislocation, cataract formation, iris injury, tear, or iridodialysis, loss of vitreous, perforation of sclera, posterior capsular bag rupture, proliferative vitreoretinopathy, pupillary block, pupillary membrane formation, retinal detachment, retinal dialysis, retinal flap tears, secondary surgical intervention, including but not limited to glaucoma surgery, and vitreous hemorrhage.

     

     

    Federal (USA) law restricts this device to sale, distribution, or use by or on the order of a physician.

    *Trademarks are property of their respective owners.

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    Indications and Safety for OMNI™ Glaucoma Treatment System
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    OMNI™ Surgical System and TearCare® are commercially available in the United States.
    OMNI™ and TearCare® are registered trademarks of Sight Sciences. SmartLids™, SmartHub™, and Clearance Assistant™ are trademarks of Sight Sciences and for use only by Sight Sciences.

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