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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 d’images: http://www.areds2.org.uk

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


AMD is the leading cause of blindness in developed countries

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


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 d’images: 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).


JCRS 2005, 31, 1618


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 (<2.8; pseudophakic)

• Aphakia

The Scharioth Macula Lens is contraindicated in the following cases:

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, García-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


Pilot study

Mean follow-up 20 months

IOL-VIP Revolution - 2012


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



Magnification -


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



Magnification -


Advantages Foldable

Disadvantages

Surgery 60 min, large incisionLong term rehabilitation

Complex surgical procedure Reduced visual field

Lack of scientific evidence/studies

IOL-K Modular Telescope

Material Hydrophilic Acrylic with UV filter

Optic 5.0 mm, -100.0 - +100.0 D


How it worksModular telescope with glasses

Without glasses: peripheral visual field is maintainedWith glasses: negative lens + positive glasses = magnification

Magnification 2.7x


Advantages For phakic and pseudo-phakic also

Disadvantages

Need of glasses for magnificationLarge incision

Long term rehabilitationLack of scientific evidence/studies

IOL-KN Microscope

Material Hydrophilic Acrylic with UV filter

Optic 5.0 mm, -100.0 - +100.0 D


How it worksCentral high positive power – magnification at 10 cm

Peripheral vision is maintined

Magnification 2.7x


Advantages Reading from 10 cm

Disadvantages COPY OF THE SML; INFRINGING PATENT

9Glens 9G-X2


Optic

2 IOLsBag: 5.0 mm, C-loop, 7°, -64.0 D, biconcaveAnterior chamber: 5.0 mm, Z-shape, 10°,

+53.0 - +63.0 D, biconvex

How it works Galilean Telescope - magnification

Implantable Miniature Telescope (Lipshitz) 2010

Material PMMA and glass

Optic 3.6 mm diameter


How it worksGalilean Telescope – magnification and deviation

1 large, rigid device, within capsular bagand protrudes through pupil

Magnification 2.2x and 2.7x

Adaptation time Several weeks

Advantages ?

Disadvantages

Surgery 45 min., Visual compromises,

Complex surgical procedure, Reduced visual field

Long term adaptationSmall groups of patients for scientific evidence

Lipshitz Telescope Studies

1 An intraocular telescopic lens for macular degeneration. 3 Mirror telescopic intraocular lens for age-related macular degeneration: design and preliminary clinical results of the Lipshitz macular implant.

Lipshitz I, Loewenstein A, Reingewirtz M, Lazar M.Ophthalmic Surg Lasers. 1997 Jun;28(6):513-7.PMID: 9189958

In-vitro tests, implantation in cadaver eyesAgarwal A, Lipshitz I, Jacob S, Lamba M, Tiwari R, Kumar DA, Agarwal A.J Cataract Refract Surg. 2008 Jan;34(1):87-94. doi: 10.1016/j.jcrs.2007.08.031.PMID: 18165087

2A prospective multicenter clinical trial to evaluate the safety and effectiveness of the implantable miniature telescope. Dr. Agarwall’s Eye Hospital, India


Prospective study

6 months follow-up

Lane SS, Kuppermann BD, Fine IH, Hamill MB, Gordon JF, Chuck RS, Hoffman RS, Packer M, Koch DD.Am J Ophthalmol. 2004 Jun;137(6):993-1001.PMID: 15183782

Multicentric (4 centers in USA) Prospective study

14 patients 1year follow-up

iolAMD - 2014

Material Hydrophobic acrylic

OpticHyper-aspheric

Bag: -50.0 - -60.0 D, biconcave, 4.0 mm opticSulcus: +60.0 D, biconvex, 5.0 mm optic


How it worksGalilean telescope – magnify and divert image

2 IOLs – capsular bag and sulcus, 0.85 mm between lensesPrismatic effect – relative decentralization – 3° tilt in image

Magnification 1.3x (can be implanted bilaterally)

Adaptation time 1-2 months

Advantages Visual field is maintained, improved near and distance vision

Disadvantages

Induced astigmatism, Decreased image quality,

Reduced visual fieldVery Expensive

Lack of scientific evidence in bigger group of patienst

iolAMD Studies

1 Injectable intraocular telescope: Pilot study.

Qureshi MA, Robbie SJ, Tabernero J, Artal P.J Cataract Refract Surg. 2015 Oct;41(10):2125-35. doi: 10.1016/j.jcrs.2015.03.021.PMID: 26703288

London Eye Hospital


Prospective interventional pilot study

4 months follow-up

2 Initial clinical results of a new telescopic IOL implanted in patients with dry age-related macular degeneration.

Hengerer FH, Artal P, Kohnen T, Conrad-Hengerer I.J Refract Surg. 2015 Mar;31(3):158-62. doi: 10.3928/1081597X-20150220-03.PMID: 25751831

London Eye Hospital


Pilot study

2 months follow-up

Eyemax Mono - 2016

Material foldable

OpticNot clear technology

13.0 - 27.0 D

Incision size Micro-incision

How it worksCapsular bag or sulcus (2017)

Enlarge image, project it around the damaged macula – high qualityimage across 15° of the macula, binocular

Magnification 20-30% (1.3 times)

Adaptation time Shorter than telescopes

Advantages

Widescreen-view, 1 IOL, Change retinal locus as AMD progresses

Not any clinical dataPredictability of vision?

Scharioth Macula Lens - 2015

Material Hydrophilic acrylic

Optic1 IOL in the sulcus:

6.0 mm, convex-concave opticBifocal IOL; 1.5 mm central addition of +10.0 D


How it worksMagnification, image on the fovea– highest visual acuity

Monocular implantation

Magnification 2.2 x

Adaptation time 1 week - 1 months

Advantages

Quick adaptabilityPREDICTABILITY

Easy surgery – micro-incision, exchangeableDistance vision not affected

Visual field not affectedPhakic and pseudophakic patients

Affordable

SML Studies

1 New add-on intraocular lens for patients with age-related macular degeneration.

Scharioth GB.J Cataract Refract Surg. 2015 Aug;41(8):1559-63. doi: 10.1016/j.jcrs.2015.07.018.PMID: 26432110

Aurelios Augenzentrum, Germany


Pilot study

Follow-up: 1 month

2 Expecting 3 articles in 2017 (finished studies)

1. Multricentric, prospective, 50 eyes, 3/ 12 months follow-up

2. Győr, retrospective, 15 eyes, 6 months follow-up

3. Hradec Kralove University Hospital, prospective, 8 eyes, 1 year follow-up

ADVANTAGES - DISADVANTAGES

Telescopic solutions iolAMD The SMLNarrow visual field ? Visual field not affected

Big incision size Micro-incision Micro-incision (2.2 mm)

Difficult and long surgery Easy surgery Easy and quick surgery

Distance vision affected ? Distance vision not affected

Long term adaptation Long term adaptation Quick adaptation

High cost ? Affordable

Unpredictable visual outcome Unpredictable visual outcome Predictable visual outcome

For phakic patient only For phakic patient only?

For phakic and pseudophakic patientsExchangeable

Clinical outcomes of eyes implanted with the Scharioth Macula Lens (A45 SML/SMY) in patients with Age

Related Macular Degeneration

Gabor B Scharioth (Recklinghausen, Germany), Anneliese Riehl (Kiehl, Germany), Ivan Tanev (Sofia, Bulgaria), Pavel Rozsival (Hradec Kralove, Czech republic), Jana Nekolova (Hradec Kralove, Czech republic), Florian Balta (Bucharest,

Romania), Emmanuel van Acker (Brussels, Belgium), Zoltan Z. Nagy (Budapest, Hungary),

SML - Scharioth Macula Lens

Sept 2016(facts so far)

6countries

7centres

60eyes

(planned)

36 eyes*(implanted)

SMLstudy centers3 months follow-up


• Implanted 48 eyes• 12 eyes excluded from the

study (not followed inclusioncriterias)

36

eyes/patients

F/M (36)

23/13

AGE

77.8

(65-94)

SML . Scharioth Macula Lens

15 patientsHungary

Almost 100 eyes Denmark

• ETDRS CHARTs

for testing


Preop CNVAadd 2.5D

Preop CNVAadd 6.0D

D1 D7 M1 M3

Series1 0,24 0,57 0,43 0,54 0,62 0,63

0,00

0,10

0,20

0,30

0,40

0,50

0,60

0,70

VA

[d

ecim

al]

UCNVA (15 cm)


NEAR VISUAL ACUITY (15 cm)

NVA Postoperative SML/15cm

NVA Preoperative+2.5/40cm


0

0,1

0,2

0,3

0,4

0,5

0,6

0,7

0.24

0.63


Mean BCDVA before surgery was 0.16. Based on inclusion criteria it ranged 0.1-0.3). Postoperative BCDVA was 0.16, 0.19, 0.20 and 0.19 in postoperative periods D1, D7, M1, M3 respectively.


preop D1 D7 M1 M3

IOP 15 14 15 16 14

10

12

14

16

18

20

IOP

(m

m/H

g)

COURSE of IOP

SIDE EFFECTs No of EYEs % Comments

Distance Vision issuesHalos/Glares 3 6.7% 2 explanted

IOP increase -

Dislocation -

Chafing effect -

Iris capture -

Vitreous loss (during implantation) 1 2.4% Not effect on VA

Vision Field loss -

COMPLICATIONS


Side effects - recommendations

• WET AMD development; we have to take into consideration that so far there is NO clear evidence that intravitreal injection of anti VGEF may prevent decompensation/development of Wet AMD (after implantation under dry & stable AMD conditions). For this reason we will not include any preventive use of anti VGEF into the protocol and Medicontur will not recommend to use it in case of commercial SML implantation

• SD-OCT macula has to be performed before surgery, max. 5 (?) days before surgery to avoid any hidden / developing wet AMD

• Inflammatory reaction in the anterior chamber. Anti-inflammatory drugs like corticosteroids (up to 3 weeks after surgery) and NSADs (up to 2 months after surgery) are recommended; we will add this point to the protocol and Medicontur will recommend it in case of commercial SML implantation.

• Far vision disturbances ("halos", "glares"). Sun glasses are recommended. If sun glasses are not effective so called Neutral Density Filter glasses can be tried; Pilocarpine should be considered in cases when glasses are not effective.

The effects of cataract surgery on patients with wet macular degeneration

Saraf SS, Ryu CL, Ober MD.; Am J Ophthalmol. 2015 Sep;160(3):487-492.e1.

doi: 10.1016/j.ajo.2015.06.006. Epub 2015 Jun 19



15 more eyes - Dr. Berecki, Györ, Hungary

SML - Scharioth Macula Lens - PREDICTABILITY

15 more eyes - Dr. Berecki, Györ, Hungary

-1

0

1

2

3

4

5

6

7

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Lines of Improvement 6W

PreOP estimate PostOP 6W

Postoperative achievement is as good as we promised or better


CONCLUSION:

MAIN MESSAGES:

• If indications are set preoperly results are good or excellent

• PREDICTABILITY = Strong correlation betweenCNVA +6.D 15 cm preop / NVA 15 cm postop• Allow to predict postoperative results and help in communication with patients, lead their expectations

• Patients were satisfied or highly satisfied

• Improvement with time/training(NVA: D1 < D7 < M1)

• TRAINING• Postsurgical training of patients• Clear instructions for doctors/patients

SML – WAY TO SUCCESS

CHOSE THE RIGHT DOCTOR

(CLINIC)

• Clinic with anterior & posterior segments departments

• = pool of patients

• = precondition of correct indication

• = proper examinations & communication

• Postsurgical treatment, training & observation of patients (centres for low vison patients training)

PATIENTs INDICATION

•MOTIVATION is the KEY

• INDICATION CRITERIAs

TRAINING & MOTIVATION

•Patients for „life“

•Never ending motivation & take care of patients

SML & Marketing Support….and much more

PATIENT SELECTION/INDICATION

MOTIVATION & PROPER TRAINING POSTOPERATIVE CARE

= crucial for success & happy patients

SML ADVISER /CONSULTANT

• Easy to use

• Time saving - quick (5 min)

• To select optimal patients who will BENEFIT from the SML

• To discuss & learn for all: doctors- distributor partners- Medicontur

• To support/increase services for doctors (especially at the starting point)