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Events
Event: American Glaucoma Society
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Event: American-European Congress of Ophthalmic Surgery (AECOS) Winter Symposium
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Event: Glaucoma 360
News
Sight Sciences Announces Substantial Crossover Raise
March 30, 2020
Sight Sciences Announces Publication of Historical Review of Canal Surgery in the Glaucoma Issue of Current Opinion in Ophthalmology

Sight Sciences, Inc., a growth-stage medical device company focused on transforming the treatment of glaucoma and dry eye disease, today announced that a review of the history of canal surgery in glaucoma, by Jaime Dickerson, Ph.D., and Reay Brown, M.D.

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    Indications and Safety for OMNI® Surgical System

    Indications for use

    The OMNI® Surgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon® PRO or HealonGV® PRO from Johnson & Johnson Vision, Amvisc® from Bausch & Lomb, or PROVISC® from Alcon, during ophthalmic surgery. It is also indicated to cut trabecular meshwork tissue during trabeculotomy procedures.
     
    For important safety information including contraindications, warnings, and precautions, please visit omnisurgical.com.
     

    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.

     

    Indications and Safety for TearCare® System

    Indications for Use

     

    The TearCare® System is indicated for the application of localized heat when the current medical community recommends the application of a warm compress to the eyelids. Such applications would include Meibomian Gland Dysfunction (MGD), Dry Eye, or Blepharitis.

     

    CONTRAINDICATIONS

     

    The TearCare System is contraindicated for patients with:

     

    • Recent (i.e. within the last 90 days) intraocular or periocular surgery.
    • Recent ocular injury.
    • Recent history of Ocular Herpes Simplex or Herpes Zoster.
    • Active ocular or periocular infection or inflammation.
    • Diminished or abnormal facial, periocular, ocular, or corneal sensation.
    • Ocular surface ulcers
    • Do not use the TearCare System in patients under the age of 22 years.

     

    WARNINGS

     

    • Do not use the TearCare System outside the instructions for use described in this manual. Doing so can result in unanticipated patient harm.
    • Do not use the TearCare System in patients with a known allergy to silicone tissue adhesives.
    • Do not attempt to connect the SmartHub or SmartLid directly to an electrical outlet of any kind.
    • Do not use the TearCare System in or near an MRI suite or near a magnetic field. Serious injury can occur to a patient or technician if a TearCare System is brought into an MRI suite.
    • The TearCare System has not been tested in the presence of flammable anesthetics or other flammable agents in combination with air, nitrous oxide, or oxygen enriched environments.

     

    PRECAUTIONS

     

    • Use of the TearCare System in patients with eyelid abnormalities (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis, etc.) may result in poor adhesion of the SmartLid to the eyelid and/or reduced benefit.
    • Use caution when using the TearCare System in patients with ocular surface abnormalities (e.g. pterygium, pingueculum, corneal dystrophies, etc.) as the heat delivered by the System may aggravate these conditions.
    • Remove contact lenses from the patient’s eyes prior to use of the TearCare System. Patients should wait 60 minutes after the completion of the TearCare procedure before re-inserting contact lenses.
    • Do not apply the SmartLids to any other part of the patient’s body including the cornea. The SmartLids are only intended for application on the external surface of the patient’s eyelids.
    • Do not reuse the SmartLids. Cross-contamination can occur if re-use is attempted.
    • Do not use a TearCare System, its components, or accessories that appear damaged. Inspect all components for damage before each use.

     

    POTENTIAL ADVERSE EVENTS

     

    Potential adverse events associated with the use of the TearCare System include the following:

     

    • Burn, erythema, or swelling of the eyelids
    • Conjunctival infection (moderate or severe)
    • Conjunctival abrasion
    • Corneal abrasion
    • Corneal deformation
    • Allergic or inflammatory reaction to medical adhesive on the SmartLid device
    • Formation of a chalazion or stye
    • Decline in visual acuity
    • Worsening of dry eye symptoms
    • Increased discomfort or pain of ocular surface (grittiness, foreign body sensation, etc.)
    • Discomfort or pain of eyelids or orbit

     

    Federal (U.S.A.) law restricts the TearCare System to the sale, distribution, or use by, or on the order of a licensed medical practitioner.

    The TearCare® System is commercially available in the United States.

    TearCare® is a registered trademark of Sight Sciences. SmartLids™, SmartHub™, and Clearance Assistant™ are trademarks of Sight Sciences and for use only by Sight Sciences.

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    Indications and Safety for OMNI® Surgical System
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    Indications and Safety for TearCare® 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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