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Transcript of Scharioth Macula Lens - Meeting/2017/DISTRIBUTORs... · PDF file• Who are...

  • SCHARIOTH MACULA LENSThe Magnifier in The Eye The New Hope for Patients with Dry AMD

  • Introduction - Age-Related Macular Degeneration

    Age-related macular degeneration (AMD) affects mostly the elderly and causes vision loss in the center of the visual field, significantly decreasing patients quality of life.

    Types of AMD:Healthy visionVision with AMD

    Neovascular or wet AMDAbnormal blood vessels appear in macula

    Dry AMDYellow deposits (drusen) in macula

    Source dimages: http://www.areds2.org.uk

    http://www.areds2.org.uk/

  • Introduction - Age-Related Macular Degeneration

    AMD is the leading cause of blindness in developed countries

    Almost 30M people suffer from AMD worldwide, 90% of them in the dry form

  • Introduction - Age-Related Macular Degeneration

    HUGE MARKET

  • Treatment Options

    Currently pharmaceutical treatment is available for wet AMD only.

    Options for patients suffering from dry AMD have been limited to

    Low vision aids: hand-held magnifiers, monoculars, loupes, electronic devices (video magnifiers)

    Surgery: Low vision magnifying intraocular implants (e.g. Lipshitz mini telescope).

    Sources dimages: http://www.drballitch.com, http://visionaid.co.uk

    http://www.drballitch.com/http://visionaid.co.uk/

  • The New Hope The Scharioth Macula Lens

    Easy and safe surgery

    Small incision

    No visual field reduction

    Unaffected distance vision

    Independent from lens status

    Reversible

    Affordable

    Goals for developing a novel solution:The Scharioth Macula Lens

    A45SML/A45SMYfrom Medicontur

    Developed by Prof. Gabor B. Scharioth

  • SML Features

    Central 1.5 mm diameter zone with +10.0D addition

    Peripheral zone optically neutral

    Bifocal design:

  • SML Features

    Round polished edges no chafing

    effect

    8 1

    Implantation site: ciliary sulcus

    2

    4 flex haptics for perfect fit

    3

    Non-torque design rotational stability

    4

    Square design no iris capture

    7

    Easy and safe surgery through 2.2 mm incision

    6

    Hydrophilic material with very low chromatic

    aberration

    5

    Convex-concave optic no IOL touch

  • SML is safe

    Proofs:

    implanted more than 3.000 patented Add-On platform

    In vitro evaluation of the lens

  • SML Mode of Action

    Near vision:Pupil is constricted (near vision miosis) light rays pass through the central region of the SML, providing a magnified image on the macula. Due to high dioptric power of the central region, sharp vision is achieved at a distance of about 15 cm (d).

    Distance vision:Pupil is dilated when focusing on a distant object light rays passing through the peripheral region of the SML will dominate over those passing through the central region (dashed lines).

  • SML Mode of Action

  • SML Mode of Action

    JCRS 2005, 31, 1618

  • SML Mode of Action

    By magnifying the image twofold, SML directs light rays to the rest of the damaged foveal region, thus enabling the patient to read, write, and resume hobbies they had to stop due to vision problems.

    Without SML With SML*

    * ANIMATION: Magnifying the image twofold

  • SML Implantation

    Implantation is done following cataract surgery but

    implantations may be performed simultaneously if

    necessary

    Monocular implantation in the better-seeing eye

    Easy implantation using a standard IOL injector through a

    2.2 mm incision

    No extensive training is required no learning curve

  • SML Clinical Evidence

    Prospective study; follow up 6 months

    8 patients/8 eyes

    Distance VA was NOT AFFECTED

    NVA improved in 7 eyes

    One patient out of 7 did not have any

    improvement of NVA due to very low BCDVA before

    surgery (0.05 ETDRS)

    Most patients were able to read newspaper

    There were not any complications related to

    surgery or to the implant occurring during

    follow up period

    Overall satisfied patients

    Scharioth GB: New add-on intraocular lens for patients with age related macular degeneration. JCRS;41:1559-1563

  • SML Clinical Evidence

  • SML Indications

    Who have dry AMD and have near vision difficulties

    Who suffer from other retinal conditions (diabetic retinopathy, myopic

    retinopathy, hereditary retinal diseases)

    Whose distance vision is better than 0.05 (ETDRS, decimal)

    Who are motivated

    Who are pseudophakic or are candidates for cataract surgery

    The Scharioth Macula Lens is recommended for patients

  • SML Contraindications

    Wet AMD (active/exudative stage)

    Zonulopathy

    Subluxation

    Progressive glaucoma

    Active iris neovascularization

    Shallow ACD (

  • SML in Use

    Better quality of life Happy patient

    Patient with vision aid Patient with SML

  • HOW TO CHOSE A PROPER PATIENT?

    KEY: MOTIVATION & COMMUNICATION WITH THE PATIENT

    implanted should be better seeing eye of the patient

    Pseudophakic patients and with dry form AMD or maculopathy or inactive neovascular AMD/othre maculopythy interval between cataract surgery and the SML implantation has to be equal or bigger than 1 months In case of clear lens crystalline in some cases might be both surgeries performed in one session

    BCDVA equal or less than 0.32 and equal or more than 0.1 (decimal ETDRS charts)

    Preoperative NVA acuity will be examined as follows: Patients will read from distance about 40 cm with the addition of +2.5 dpt(examination A) and from distance about 15 cm with the addition of +6 dpt (examination B). Only if there will be an improvement; the best 3 or more lines with the examination B compare to examination A; BUT if 1 or 2 lines improved and patients is happy with it the SML is indicated

    IMPORTANT: based on below explained test, we can PREDICT patient NVA after the SML implantation important for communication and for patients understanding about the probable vision after surgery

  • EXCLUSION CRITERIA:

    Active neovascular AMD/maculopathy

    BCDVA worse than 0.1 or better than 0.32 (ETDRS charts; decimal)

    iris neovascularisation

    severe zonulopathy

    ACD < 2.8 mm (from endotel)

    Narrow angle, i.e., < Schaefer grade 2

    Status post complicated eye surgery

    congenital eye abnormality

    advanced glaucoma with significant visual field defects

    pigment dispersion syndrome

    uveitis

    long-term anti-inflammatory treatment

    retinal detachment

    corneal diseases involving the central cornea

    inadequate visualization of the fundus on preoperative examination

    patients deemed by the clinical investigator because of any systemic disease.

    Pupilary abnormalities; photopic pupil less than 2.5 mm

    no-go criteria :

    unexpected surgical complication

  • SML CompetitorsMarket overview

  • Telescopic solution

    IOL-VIP

    IOL-Revolution

    IOL-Foldable

    IOL-K

    9G-X2

    Lipshitz telescope

    The SchariothMacula Lens

    Real Competitors

    iolAMD

    iolAMD EyeMax

  • IOL-VIP

    2007

    2010

    Lipshitztelescope

    IOL-VIP Revolution

    2012

    2014

    iolAMD

    SchariothMacula

    Lens

    2015

    2016

    iolAMDEyeMaxMono

  • IOL-VIP - 2007

    Material PMMA with UV filter

    Optic2 IOLs

    Bag: 5.0 mm, 7, C-loops, -64 D, biconcaveAnterior chamber: 5.0 mm, 10, Z-shape, +55 D, biconvex

    Incision size 8.0 mm

    How it works Galilean telescope magnification and deviation of image

    Magnification 1.3x, prismatic effect 10 D, monocular

    Adaptation time 12 weeks rehabilitation

    Advantages Improved vision

    Disadvantages

    Surgery 45 min; large incision sizeSutures needed

    Reduced field of viewLong term rehabilitation

  • IOL-VIP Studies

    1 Clinical magnification and residual refraction after implantation of a double intraocular lens system in patients with macular degeneration.

    Amselem L1, Diaz-Llopis M, Felipe A, Artigas JM, Navea A, Garca-Delpech S.J Cataract Refract Surg. 2008 Sep;34(9):1571-7. doi: 10.1016/j.jcrs.2008.05.032.PMID: 18721722

    Hospital General Universitario, Spain

    13 eyes of 10 patients

    Prospective study

    1 year follow-up

    2 The IOL-Vip System: a double intraocular lens implant for visual rehabilitation of patients with macular disease.

    Orzalesi N1, Pierrottet CO, Zenoni S, Savaresi C.Ophthalmology. 2007 May;114(5):860-5.PMID: 17467525

    Italy

    40 eyes of 35 patients

    Pilot study

    Mean follow-up 20 months

  • IOL-VIP Revolution - 2012

    Material PMMA with UV filter

    Optic2 IOLs in the bag

    5.0 mm, 15, 0.0 - -100.0 D, biconcave5.0 mm, 10,0.0 - +100.0 D, biconvex within a silicone gutter

    Incision size 8.0 mm

    How it works Galilean telescope magnification and deviation of image

    Magnification -

    Adaptation time 12 weeks rehabilitation

    Advantages Easily rotated

    Disadvantages

    Surgery 60 min, large incisionSutures needed

    Complex surgical procedure Reduced visual field

    Long term rehabilitationLack of scientific evidence /studies

  • IOL-VIP Foldable

    Material Acrylic with UV filter

    Optic2 IOLs

    Bag: 5.0 mm, 0.0 - -100.0 D Sulcus: 5.0 mm, 0.0 - +100.0 D

    Incision size 8.0 mm

    How it works Galilean telescope magnificatio