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Dry Eye 2020

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conditions. Use of the device in patients with these conditions may cause injury. Safety and effectiveness of the device have not been studied in patients with these conditions. •Ocular surgery<br />

within prior 3 months, including intraocular, oculo-plastic, corneal or refractive surgery procedure •Ocular injury within prior 3 months Ocular herpes of eye or eyelid within prior 3 months<br />

INDICATIONS FOR USE:The LipiFlow System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including<br />

Meibomian Gland Dysfunction (MGD), also known as Evaporative <strong>Dry</strong> <strong>Eye</strong> or Lipid Deficiency <strong>Dry</strong> <strong>Eye</strong>. CONTRAINDICATIONS:Do not use the LipiFlow System in patients with the following<br />

86% MGD has been shown<br />

•Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye) •Active<br />

Treat<br />

Treat<br />

Treat<br />

to affect 86% of<br />

patients with dry eye 1<br />

86% MGD has been shown<br />

to affect 86% of<br />

86%<br />

patients with dry eye MGD has has been shown<br />

1<br />

86%<br />

to to affect 86% of of<br />

MGD patients has with with been dry dry eye shown eye 1 1<br />

to affect 86% of<br />

patients with dry eye<br />

Treat<br />

1<br />

INDICATIONS FOR USE:The LipiFlow System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including<br />

Meibomian Gland Dysfunction (MGD), also known as Evaporative <strong>Dry</strong> <strong>Eye</strong> or Lipid Deficiency <strong>Dry</strong> <strong>Eye</strong>. CONTRAINDICATIONS:Do not use the LipiFlow System in patients with the following<br />

conditions. Use of the device in patients with these conditions may cause injury. Safety and effectiveness of the device have not been studied in patients with these conditions. •Ocular surgery<br />

within prior 3 months, including intraocular, oculo-plastic, corneal or refractive surgery procedure •Ocular injury within prior 3 months Ocular herpes of eye or eyelid within prior 3 months<br />

•Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye) •Active<br />

ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months (e.g., retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis)<br />

•<strong>Eye</strong>lid abnormalities that affect lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) •Ocular surface abnormality that may<br />

INDICATIONS compromise FOR corneal FOR USE:The integrity USE:The LipiFlow (e.g., LipiFlow prior System System chemical is intended is burn, intended for recurrent the for the corneal application erosion, of localized of localized corneal heat heat epithelial and pressure and pressure defect, therapy Grade therapy in 3 adult corneal in adult patients fluorescein patients with with chronic staining, chronic cystic or cystic map conditions dot conditions fingerprint of the of eyelids, the dystrophy) eyelids, including including<br />

Meibomian PRECAUTIONS:The Gland Gland Dysfunction Activator (MGD), or (MGD), Activator also also known II known (Disposable) as as Evaporative may <strong>Dry</strong> not <strong>Dry</strong> <strong>Eye</strong> fit all or <strong>Eye</strong> eyes, Lipid or Lipid such Deficiency Deficiency as eyes <strong>Dry</strong> with <strong>Dry</strong> <strong>Eye</strong>. small <strong>Eye</strong>. palpebral CONTRAINDICATIONS:Do fornices. Use of the not LipiFlow use not the use System LipiFlow the LipiFlow in System patients System in with patients in the patients following with with the conditions following the following may<br />

conditions. result in Use reduced Use of the of treatment device the device in patients effectiveness in patients with with because these these conditions these conditions may may cause may cause injury. cause injury. Safety ocular Safety and symptoms and effectiveness unrelated of the of to device the cystic device have meibomian have not been not glands been studied studied and in require patients in patients other with medical with these these management. conditions. •Ocular Safety •Ocular surgery and surgery<br />

within within effectiveness prior prior 3 months, 3 of months, the including device including have not intraocular, been studied oculo-plastic, in patients corneal corneal with these refractive or refractive conditions. surgery surgery •Moderate procedure procedure to •Ocular severe •Ocular (Grade injury injury within 2-4) within allergic, prior prior 3 vernal months 3 months or Ocular giant Ocular papillary herpes herpes of conjunctivitis eye of or eye eyelid or eyelid •Severe within within prior (Grade prior 3 months 3 or 3 months 4) eyelid<br />

•Active •Active inflammation(e.g., ocular ocular infection infection blepharochalasis, (e.g., (e.g., viral, viral, bacterial, bacterial, staphylococcal mycobacterial, blepharitis protozoan, protozoan, or seborrheic fungal fungal infection blepharitis). infection of the Patients of cornea, the cornea, with severe conjunctiva, eyelid lacrimal inflammation lacrimal gland, gland, lacrimal should lacrimal sac, be treated or sac, eyelids or medically eyelids including including prior a to a device hordeolum use •Systemic stye) or stye) •Active •Active disease<br />

ocular INDICATIONS ocular conditions inflammation that cause FOR or history dry USE:The history eye(e.g., of chronic, LipiFlow of chronic, Stevens-Johnson recurrent System recurrent ocular is intended syndrome, ocular inflammation for vitamin the application within A deficiency, within prior of prior localized 3 months rheumatoid 3 months heat (e.g., and (e.g., arthritis, retinitis, pressure retinitis, Wegener’s macular therapy macular granulomatosis, inflammation, adult patients sarcoidosis, with choroiditis, chronic uveitis, leukemia, uveitis, cystic iritis, conditions iritis, scleritis, Riley-Day scleritis, of syndrome, the episcleritis, eyelids, keratitis) systemic including keratitis) lupus<br />

•<strong>Eye</strong>lid Meibomian •<strong>Eye</strong>lid erythematosus, abnormalities Gland Sjögren's that Dysfunction that affect syndrome) affect lid function (MGD), lid function •Taking (e.g., also (e.g., known medications entropion, entropion, as Evaporative ectropion, known ectropion, to <strong>Dry</strong> tumor, cause <strong>Eye</strong> tumor, dryness edema, Lipid edema, (e.g., Deficiency blepharospasm, isotretinoin <strong>Dry</strong> (Accutane®) <strong>Eye</strong>. lagophthalmos, CONTRAINDICATIONS:Do and severe systemic severe trichiasis, antihistamines) trichiasis, severe not severe ptosis) use •Esthetic ptosis) •Ocular LipiFlow •Ocular eyelid surface System and surface eyelash in abnormality patients procedures that with that may the (e.g., may following<br />

conditions. compromise blepharoplasty, corneal Use corneal lash of integrity the extensions, integrity device (e.g., in (e.g., prior patients eyelid prior chemical tattooing). with chemical these burn, In burn, conditions recurrent addition, recurrent the corneal may treatment corneal cause erosion, injury. erosion, procedure corneal Safety corneal epithelial may and epithelial effectiveness loosen defect, previously defect, Grade of the Grade inserted 3 device corneal 3 corneal have punctal not fluorescein plugs, been staining, studied which staining, may or patients map worsen map dot with the dot patient’s these fingerprint conditions. dry dystrophy) eye symptoms. •Ocular surgery<br />

within PRECAUTIONS:The Reference: prior 1. 3 Lemp, months, Activator M. Activator including A., Crews, Activator intraocular, L. Activator A., Bron, II A. II oculo-plastic, (Disposable) J., Foulks, may G. N., corneal may not & fit not Sullivan, all or fit eyes, refractive all B. eyes, such D. (2012). such surgery as eyes as Distribution eyes with procedure with small small of palpebral •Ocular Aqueous-Deficient palpebral injury fornices. fornices. within Use and prior Use of Evaporative the of 3 LipiFlow months the LipiFlow <strong>Dry</strong> Ocular System <strong>Eye</strong> System in herpes a in Clinic-Based patients of patients eye with or Patient eyelid with the following Cohort. the within following Cornea, prior conditions 3 conditions months 31(5), may may<br />

result •Active result 472-478. in reduced in ocular reduced doi:10.1097/ico.0b013e318225415a. treatment infection treatment (e.g., effectiveness viral, bacterial, because because these mycobacterial, these Australia: conditions conditions protozoan, AMO may may cause Australia cause or ocular fungal Pty ocular symptoms Ltd, infection symptoms 1-5 Khartoum unrelated of the unrelated cornea, Road, to cystic to conjunctiva, North cystic Ryde, meibomian NSW lacrimal glands 2113, glands gland, Australia. require and lacrimal require Phone: other sac, other or medical 1800 eyelids medical 266 111. including management. New Zealand: a hordeolum Safety Safety AMO and or and Australia stye) •Active Pty.<br />

ocular effectiveness Ltd. 507 inflammation Mount of the of device Wellington the device or have history Hwy, have not been not of Mount chronic, been studied Wellington, studied recurrent patients in Auckland patients ocular with 1060, inflammation with these these New conditions. Zealand. within •Moderate Phone: prior •Moderate 30800 months to severe to 266 severe (e.g., 700. (Grade retinitis, (Grade PP2018OTH4191<br />

2-4) 2-4) allergic, macular allergic, vernal inflammation, vernal or giant or giant papillary choroiditis, papillary uveitis, conjunctivitis iritis, •Severe scleritis, •Severe (Grade episcleritis, (Grade 3 or 34) or keratitis) eyelid 4) eyelid<br />

•<strong>Eye</strong>lid inflammation(e.g., abnormalities blepharochalasis, that affect lid function staphylococcal (e.g., blepharitis entropion, blepharitis or ectropion, seborrheic seborrheic tumor, blepharitis). edema, Patients blepharospasm, Patients with with severe severe lagophthalmos, eyelid eyelid inflammation severe should trichiasis, should be severe treated be treated ptosis) medically medically •Ocular prior prior surface to device to abnormality device use •Systemic use •Systemic that disease may disease<br />

conditions compromise conditions that that cause corneal cause dry integrity eye(e.g., dry eye(e.g., (e.g., Stevens-Johnson prior chemical syndrome, burn, syndrome, recurrent vitamin vitamin corneal A deficiency, A deficiency, erosion, corneal rheumatoid epithelial arthritis, arthritis, defect, Wegener’s Wegener’s Grade 3 corneal granulomatosis, fluorescein sarcoidosis, staining, leukemia, or leukemia, map Riley-Day dot Riley-Day fingerprint syndrome, syndrome, dystrophy) systemic systemic lupus lupus<br />

PRECAUTIONS:The erythematosus, Sjögren's Sjögren's syndrome) Activator syndrome) or •Taking Activator •Taking II medications (Disposable) known known may to cause not to cause fit dryness all dryness eyes, (e.g., such (e.g., as eyes isotretinoin with small (Accutane®) palpebral and systemic and fornices. systemic Use antihistamines) of the LipiFlow •Esthetic •Esthetic System eyelid in eyelid patients and eyelash and with eyelash the following procedures (e.g., conditions (e.g., may<br />

result blepharoplasty, in reduced lash lash treatment extensions, eyelid effectiveness eyelid tattooing). tattooing). because In addition, these In addition, conditions the treatment the treatment may cause procedure procedure ocular may symptoms may loosen loosen previously unrelated previously to inserted cystic inserted meibomian punctal punctal plugs, glands plugs, which and which may require may worsen worsen other the medical patient’s the patient’s management. dry eye dry eye symptoms. Safety and<br />

effectiveness Reference: 1. Lemp, 1. of Lemp, the M. A., device M. Crews, A., have Crews, L. A., not L. Bron, been A., Bron, A. studied J., A. Foulks, J., in Foulks, patients G. N., G. & N., with Sullivan, & these Sullivan, B. conditions. D. B. (2012). D. (2012). •Moderate Distribution Distribution to of severe of Aqueous-Deficient (Grade 2-4) and allergic, and Evaporative vernal <strong>Dry</strong> giant <strong>Eye</strong> <strong>Dry</strong> in <strong>Eye</strong> papillary a a Clinic-Based conjunctivitis Patient Patient Cohort. •Severe Cohort. Cornea, (Grade Cornea, 31(5), 3 or 31(5), 4) eyelid<br />

472-478. inflammation(e.g., 472-478. doi:10.1097/ico.0b013e318225415a. blepharochalasis, staphylococcal Australia: Australia: blepharitis AMO AMO Australia or seborrheic Australia Pty Ltd, Pty blepharitis). Ltd, 1-5 Khartoum 1-5 Khartoum Patients Road, with Road, North severe North Ryde, eyelid Ryde, NSW inflammation NSW 2113, 2113, Australia. Australia. should Phone: be Phone: treated 1800 1800 266 medically 111. 266 111. New prior New Zealand: to Zealand: device AMO use AMO Australia •Systemic Australia Pty. disease Pty.<br />

Ltd. 507 conditions Ltd. 507 Mount Mount Wellington that Wellington cause dry Hwy, eye(e.g., Hwy, Mount Mount Stevens-Johnson Wellington, Auckland Auckland syndrome, 1060, 1060, New vitamin New Zealand. A Zealand. deficiency, Phone: Phone: 0800 rheumatoid 0800 266 266 700. arthritis, 700. PP2018OTH4191<br />

Wegener’s granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus<br />

erythematosus, Sjögren's syndrome) •Taking medications known to cause dryness (e.g., isotretinoin (Accutane®) and systemic antihistamines) •Esthetic eyelid and eyelash procedures (e.g.,<br />

blepharoplasty, lash extensions, eyelid tattooing). In addition, the treatment procedure may loosen previously inserted punctal plugs, which may worsen the patient’s dry eye symptoms.<br />

Reference: 1. Lemp, M. A., Crews, L. A., Bron, A. J., Foulks, G. N., & Sullivan, B. D. (2012). Distribution of Aqueous-Deficient and Evaporative <strong>Dry</strong> <strong>Eye</strong> in a Clinic-Based Patient Cohort. Cornea, 31(5),<br />

472-478. doi:10.1097/ico.0b013e318225415a. Australia: AMO Australia Pty Ltd, 1-5 Khartoum Road, North Ryde, NSW 2113, Australia. Phone: 1800 266 111. New Zealand: AMO Australia Pty.<br />

Ltd. 507 Mount Wellington Hwy, Mount Wellington, Auckland 1060, New Zealand. Phone: 0800 266 700. PP2018OTH4191<br />

WWW.EYEONOPTICS.CO.NZ | 25

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