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