Rev 2 Raindrop Patient Atlas_Layout 1 9/23/2013 7:16 AM Page 2 2 of 20

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The Raindrop

Near Vision Inlay Patient Atlas is a surgical guide to

selecting and treating presbyopic patients.

The Patient Atlas includes information on selecting and treating the

following types of presbyopic patients:

• Myopes

• Emmetropes

• Hyperopes

ReVision Optics is committed to helping you achieve optimal outcomes for

each and every one of your Raindrop patients.

INDICATIONS FOR USE

The Raindrop Near Vision Inlay is intended to improve near vision

and decrease dependence on near vision correction modalities in

adult presbyopic patients.

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Naturally reshapes the cornea to create

near vision in the center of the visual axis

and gradually transitions to intermediate

and distance vision out to the periphery.

Stromal Cushion ≥ 100 μm Progressive Prolate Shape

Bowman’s Layer

Flap Bed

Flap thickness ⅓ depth of the cornea

Inlay Thickness 30 μm

99.7% light transmission 30 µm Meniscus shape

2 mm

Proprietary hydrogel material Approx. 80% water content 98% - 100% glucose concentration through the cornea1

91% - 100% oxygen concentration through the cornea1

Similar refractive index as the cornea (1.371) Removable, patient will return

to preop DCVA

Pro

foca

l

Shape Changing Techno

logy

Natura

lly Biocompatible

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Clinical Parameters

Patient Selection

Healthy Cornea and Ocular Surface

-

Reduce/manage dry eye and MGD prior to surgery

-

Procedure requirements:

⅓ of corneal thickness femtosecond laser flap (minimum 150 µm)

Minimum 300 µm stromal bed

Central corneal thickness between 500 µm and 600 µm

-

AVOID - Poor air quality at work/home (includes smokers)

-

AVOID - Patients with hobbies that may require precise visual demands

-

AVOID - Patients with corneal dystrophies including keratoconus or

forme fruste

Refractive error within excimer range (-6.0 D to +3.0 D)

Photopic pupil size minimum 3 mm

Set Proper Patient Expectations

Desires good near and intermediate vision accepting a slight

compromise in distance vision monocularly

May need reading glasses for extended periods of near vision activities

Recommend screening patients using a multifocal contact lens

evaluation

Drug Regimen

Preoperative

-

Remove all make up and clean eyelids

-

Start with artificial tears for optimal ocular surface

Postoperative

-

Antibiotic (no BAK) for 1 week

-

Steroid (no BAK) regimen for 3 months

First Month: Strong steroid (Dexa-free or equivalent) Taper

Second Month: Weaker steroid (FML or equivalent) BID

Third Month: Weaker steroid (FML or equivalent) QD

-

Prevent Dry Eye: Punctal Plugs, Preservative-Free Artificial Tears

Clinical

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Summary of T

reatment Parameters

Myope

Emmetrope

Low Hyperope

Hyperope

Non-dominant Eye

T

arget +0.75 D and Raindrop

Raindrop only or T a rget Plano with ablation Raindrop only T

arget +0.75 D and Raindrop

Dominant Eye

No

surgical treatment

T

arget Plano with ablation

+0.75 D 0.00 D -6.00 D +1.75 D +3.00 D T

arget Plano with ablation

T

reatment

Parameters

Below is a graphical representation of the dif

ferent treatment options based upon the preoperative refraction.

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Visual

Ta

sk

P

e

rf

o

rm

a

n

ce

Ques

onnair

e

NE

AR

P

a

en

ts

ask

e

d if the

y

can…

1)

R

ead medicine

ins

trucons

2)

R

ead newspaper

arcle

3)

Ex

amine fing

ernails

4)

Dial cell

phone

5)

R

ead mag

a

zine

INTERMEDIA

T

E

P

a

en

ts

ask

e

d if the

y

can…

1)

Find

it

ems on

kit

chen shelf

2)

R

e

ad a comput

er

scr

een

3)

Use a ba

thr

oom

mirr

or

4)

Use a w

a

ll

calendar

5)

R

e

co

gniz

e phot

o portr

a

its

DIS

TANCE

P

a

en

ts ask

e

d

if

the

y

can…

1)

R

e

ad s

tr

e

et

signs

2)

Iden

fy

people acr

oss

room

3)

Judg

e car

dis

ta

n

ces

4)

R

e

ad house number

s

5)

Te

ll me

fr

om

w

a

ll clock

P

a

en

ts

ma

y

answ

er…

“With

ease”

=

2

poin

ts

“With

difficulty

=

1

poin

t

“Not

at

all”

=

0

poin

ts

R

e

sponses

in

both

GOOD

&

DIM

LIGHT

T

his questionnair

e is used as a measur

ement f

or func

tional vision. Belo

w is a basic description of the questionnair

e with sc

ori

ng

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+3.00 D to +1.75 D

Treatment

Non-dominant Eye

-

Raindrop treated eye

-

LASIK Target Ablation: +0.75 D

-

Correct all Cylinder

Dominant Eye

-

LASIK Target Ablation: Plano

-

Correct all Cylinder

Clinical Results

Uncorrected Visual Acuities (UCVA)

1

(LogMar)

Average UCVA, 6 months postop

Task Performance

1

(Not at all = 0, With difficulty = 1, With ease = 2)

Patient Symptoms

1

Patient Satisfaction

1

1Data on file at ReVision Optics, Inc.

Comparison of UCVA Binocularly

Preop n=26 1 Month n=26 6 Months n=26 UNVA 0.1 or better 0% 81% 81% UIVA 0.2 or better 0% 89% 100% UDVA 0.1 or better 0% 100% 100%

Comparison of UCVA in Raindrop Treated Eye

Preop n=26 1 Month n=26 6 Months n=26 UNVA 0.1 or better 0% 77% 77% UIVA 0.2 or better 0% 77% 77% UDVA 0.1 or better 0% 27% 19%

Dim Light Preop

n=26

6 Months n=26

Read magazine 0.0 1.8

Read computer screen 0.3 1.8

Read street signs 0.6 1.9

Good Light Preop

n=26

6 Months n=26

Read magazine 0.1 2.0

Read computer screen 0.4 1.9

Read street signs 1.0 2.0

Patient Satisfaction at 6 months

Near n=26 Intermediate n=26 Distance n=26 Overall n=26 Satisfied 85% 96% 100% 88% Neutral 15% 4% 0% 12% Dissatisfied 0% 0% 0% 0%

Self Reported Patient Symptoms

% Moderate to Worse Preop

n=26 6 Months n=26 Ocular Dryness 0% 8% Light Sensitivity 8% 8% Glare 4% 8% Halos 0% 23% 5 10 15 20 25 30 35 40 45 50 55

Preoperative 1 Day 1 Week 1 Month 3 Months 6 Months

Mean Vi s u al A c u it y 26 -0.1 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 LogMAR Decimal 26 26 26 26 26 0.9 0.13 0.16 0.2 0.25 0.33 0.4 0.5 0.6 0.8 1.0 1.2

Near (MONO) Intermediate (MONO) Distance (MONO) Distance (BINO)

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Low Hyperope

+1.50 D to +1.00 D; Up to 0.75 D of Cylinder

Treatment

Clinical Results

Binocular Uncorrected Visual Acuities (UCVA)

1

(LogMar)

1Data on file at ReVision Optics, Inc.

continued on other side...

Comparison of UCVA in Bilateral Raindrop Treated Eyes

Preop n=23 3 Month n=20 6 Months n=18 UNVA 0.1 or better 0% 100% 94% UIVA 0.2 or better 4% 100% 100% UDVA 0.1 or better 61% 95% 100%

Comparison of UCVA in Raindrop in Non-Dominant Eye and LASIK in Dominant Eye

Preop n=14 3 Month n=14 6 Months n=14 UNVA 0.1 or better 0% 86% 93% UIVA 0.2 or better 4% 100% 100% UDVA 0.1 or better 61% 100% 100% 10 15 20 25 30 35 40 45 50 55

Preoperave 3 Months 6 Months

M e a n Acuity (Log M A R)

Near Intermediate Distance

14 14 -0.1 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 14 1.2 1.0 0.8 0.6 0.5 0.4 0.33 0.25 0.2 0.16 LogMAR Decimal 10 15 20 25 30 35 40 45 50 55

Preoperave 3 Months 6 Months

Mean A cu it y (Lo g MA R)

Near Intermediate Distance

23 20 - 0.1 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 18 1.2 1.0 0.8 0.6 0.5 0.4 0.33 0.25 0.2 0.16 Decimal LogMAR Non-dominant Eye

- Raindrop treated eye - No LASIK ablation Dominant Eye - No surgical treatment At Three Months - UDVA 20/25 or better? - UNVA 20/32 or better?

- Patient elects a second Raindrop inlay?

Bilateral Raindrop Treatment

- Raindrop in the dominant eye - No LASIK ablation

LASIK in Dominant Eye

- Target plano - Correct all Cylinder

YES

NO

Low Hyperope

Raindrop in Non-Dominant Eye and LASIK in Dominant Eye UCVA, 6 months postop Bilateral Raindrop UCVA, 6 months postop

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Task Performance

(Not at all = 0, With difficulty = 1, With ease = 2)

Patient Symptoms

1

Patient Satisfaction

1

1Data on file at ReVision Optics, Inc.

Bilateral Patient Satisfaction at 6 months

Near n=18 Intermediate n=18 Distance n=18 Overall n=18 Satisfied 89% 94% 78% 83% Neutral 11% 0% 17% 17% Dissatisfied 0% 6% 6% 0%

Raindrop in Non-Dominant Eye and LASIK in Dominant Eye Patient Satisfaction at 6 months

Near n=14 Intermediate n=14 Distance n=14 Overall n=14 Satisfied 79% 100% 79% 79% Neutral 14% 0% 14% 14% Dissatisfied 7% 0% 7% 7%

Bilateral Raindrop Self Reported Patient Symptoms

% Moderate to Worse Preop

n=23 6 Months n=18 Ocular Dryness 9% 6% Light Sensitivity 9% 11% Glare 0% 0% Halos 0% 17%

Raindrop in Non-Dominant Eye and LASIK in Dominant Eye Self Reported Patient Symptoms

% Moderate to Worse Preop

n=14 6 Months n=14 Ocular Dryness 7% 14% Light Sensitivity 7% 21% Glare 0% 0% Halos 0% 21% Bilateral Raindrop Good Light Preop n=23 6 Months n=18 Read magazine 0.3 1.9

Read computer screen 0.8 1.9

Read street signs 1.7 1.7

Raindrop in Non-Dominant Eye and LASIK in Dominant Eye

Dim Light Preop n=14 6 Months n=14 Read magazine 0.0 1.4

Read computer screen 0.4 1.5

Read street signs 1.6 1.6

Bilateral Raindrop Dim Light Preop n=23 6 Months n=18 Read magazine 0.0 1.7

Read computer screen 0.5 1.9

Read street signs 1.2 1.7

Raindrop in Non-Dominant Eye and LASIK in Dominant Eye

Good Light Preop n=14 6 Months n=14 Read magazine 0.2 1.9

Read computer screen 0.6 1.9

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Emmetrope

+0.75 D to 0.00 D; up to 0.75 D of Cylinder

Treatment

Non-dominant eye

-

Raindrop treated eye

-

No LASIK ablation

Dominant eye

-

No surgical treatment

Patients must have UDVA 20/25 or better binocularly.

Clinical Results

Uncorrected Visual Acuities (UCVA)

1

(LogMar)

Average UCVA, 6 months postop

Task Performance

1

(Not at all = 0, With difficulty = 1, With ease = 2)

Patient Symptoms

1

Patient Satisfaction

1

1Data on file at ReVision Optics, Inc.

Comparison of UCVA Binocularly

Preop n=68 1 Month n=68 6 Months n=64 UNVA 0.1 or better 0% 88% 86% UIVA 0.2 or better 25% 93% 95% UDVA 0.1 or better 100% 100% 100%

Comparison of UCVA in Raindrop Treated Eye

Preop n=68 1 Month n=68 6 Months n=64 UNVA 0.1 or better 0% 84% 83% UIVA 0.2 or better 15% 90% 95% UDVA 0.1 or better 100% 53% 56%

Patient Satisfaction at 6 months

Near n=61 Intermediate n=61 Distance n=61 Overall n=64 Satisfied 80% 87% 90% 78% Neutral 10% 10% 8% 16% Dissatisfied 10% 3% 2% 6%

Self Reported Patient Symptoms

% Moderate to Worse Preop

n=68 6 Months n=64 Ocular Dryness 1% 9% Light Sensitivity 4% 14% Glare 0% 3% Halos 0% 13%

Good Light Preop

n=68

6 Months n=64

Read magazine 0.4 1.8

Read computer screen 1.2 1.7

Read street signs 2.0 2.0

Dim Light Preop

n=68

6 Months n=64

Read magazine 0.1 1.4

Read computer screen 1.0 1.6

Read street signs 1.9 1.8

Near (MONO) Intermediate (MONO) Distance (MONO) Distance (BINO)

5 10 15 20 25 30 35 40 45 50 55

Preoperative 1 Day 1 Week 1 Month 3 Months 6 Months

Mean Vi su al A c u it y 68 -0.1 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 LogMAR Decimal 64 64 68 68 68 0.9 0.13 0.16 0.2 0.25 0.33 0.4 0.5 0.6 0.8 1.0 1.2

Emmetrope

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-0.25 D to -6.00 D

Treatment

Non-dominant Eye

-

Raindrop treated eye

-

LASIK Target Ablation: +0.75 D

-

Correct all Cylinder

Dominant Eye

-

LASIK Target Ablation: Plano

-

Correct all Cylinder

Clinical Results

Uncorrected Visual Acuities (UCVA)

1

(LogMAR)

Average UCVA, 6 months postop

Task Performance

1

Patient Symptoms

1

Patient Satisfaction

1

1Data on file at ReVision Optics, Inc.

Comparison of UCVA Binocularly

Preop n=37 1 Month n=36 6 Months n=33 UNVA 0.1 or better 65% 97% 97% UIVA 0.2 or better 68% 94% 100% UDVA 0.1 or better 5% 100% 100%

Comparison of UCVA in Raindrop Treated Eye

Preop n=37 1 Month n=36 6 Months n=33 UNVA 0.1 or better 49% 92% 94% UIVA 0.2 or better 60% 94% 100% UDVA 0.1 or better 5% 36% 27%

Patient Satisfaction at 6 months

Near n=33 Intermediate n=33 Distance n=33 Overall n=33 Satisfied 73% 94% 94% 97% Neutral 21% 6% 3% 3% Dissatisfied 6% 0% 3% 0%

Self Reported Patient Symptoms

% Moderate to Worse Preop

n=37 6 Months n=33 Ocular Dryness 3% 3% Light Sensitivity 3% 3% Glare 3% 0% Halos 3% 0%

Good Light Preop

n=37

6 Months n=33

Read magazine 1.7 1.9

Read computer screen 1.2 2.0

Read street signs 0.7 2.0

Dim Light Preop

n=37

6 Months n=33

Read magazine 1.2 1.3

Read computer screen 0.9 1.7

Read street signs 0.5 1.7

5 10 15 20 25 30 35 40 45 50 55

Preoperative 1 Day 1 Week 1 Month 3 Months 6 Months

Mean Vi su al A c u it y 37 -0.1 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 LogMAR Decimal 33 36 36 36 37 0.9 0.13 0.16 0.2 0.25 0.33 0.4 0.5 0.6 0.8 1.0 1.2 Near (MONO) Intermediate (MONO) Distance (MONO) Distance (BINO)

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Surgical practice guidelines are established by a systematic review of available data and reported experiences with the Raindrop™Near Vision Inlay. The approach suggested might not

necessarily be the only acceptable approach given the complexity of the healthcare

environment. These guidelines are not a substitute for medical judgment, as the surgeon must always choose the approach best suited to an individual patient.

Contraindications

The Raindrop Near Vision Inlay is contraindicated in patients with ocular pathology,

keratoconus, collagen vascular, autoimmune or immunodeficiency diseases; in pregnant or nursing women; in patients who are taking one or both of the following medications: isotretinoin (Accutane®1), amiodarone hydrochloride (Cordarone®2); in the presence of ocular conditions

such as recurrent corneal erosion syndrome or corneal dystrophy, that may predispose the patient to future complications.

Warnings

• The Raindrop Near Vision Inlay is not recommended in patients with a history of chronic ophthalmic allergies, ophthalmic herpes simplex, or ophthalmic herpes zoster.

• The Raindrop Near Vision Inlay is not recommended in patients with systemic diseases that are likely to affect wound healing, such as insulin dependent diabetes or severe atopic diseases. • The Raindrop Near Vision Inlay is not recommended in patients with a photopic pupil size of

<3.0 mm in the eye to be implanted.

• In the event of a complication during corneal flap creation, the inlay should not be implanted. • If the inlay becomes dislodged from the delivery device prior to placement on the stromal

bed, discard and prepare a new Raindrop Near Vision Inlay.

• Do not implant the inlay in patients with prior LASIK surgery with a microkeratome flap, or under a flap <150 microns or flap of unknown thickness.

• For patients with prior ocular surgery, ensure sufficient healing has occurred prior to initiating flap creation or Raindrop implantation.

Precautions

• Inspect packaging before use. If the seal is broken, do not use. Prior to use, the inlay should be inspected for tears or creases. Care should be taken when handling the inlay to avoid damaging it.

• Implantation of the Raindrop Near Vision Inlay should be performed in an environment appropriate for ocular surgery.

• The Raindrop Near Vision Inlay and Raindrop Inserter are for single-use only. Do not re-use or re-sterilize.

Potential Risks

Implantation of the Raindrop Near Vision Inlay has the potential to cause problems with the cornea such as: foreign body sensation, dry eye syndrome, corneal perforation, corneal scarring, recurrent corneal erosion, corneal infection or ulceration, corneal melting, corneal haze, intra-corneal deposits, corneal opacities, corneal decompensation, or epithelial ingrowth. Other risks include, but are not limited to, endothelial cell density loss, cataract formation, over correction, under correction, reduced stereo acuity, reduced contrast sensitivity, and increased visual symptoms such as glare, halos and double vision. Visual symptoms may be more severe at night or in dim lighting conditions.

1Accutane is a registered trademark of Hoffmann-La Roche Inc. 2Cordarone is a registered trademark of Sanofi-Synthelabo.

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Directions for Use

1. Administer topical analgesic and appropriate concomitant medications to the subject’s eye. 2. Prep and drape the patient according to standard surgical procedure.

3. Place the patient into position under the surgical microscope.

4. Create a corneal flap of approximately ⅓ of the central corneal thickness. The corneal flap must be a minimum of 150 μm thick, and the residual stromal bed must be a minimum of 300 μm thick. Follow the laser keratome manufacturer’s instructions when creating the corneal flap. 5. If the corneal flap is irregular in size or shape, or if any complication should occur during the

creation or manipulation of the flap, DO NOT IMPLANT the Raindrop Near Vision Inlay.

6. The surgical assistant should prepare the Raindrop Near Vision Inlay for implantation as follows using sterile, powder-free nitrile gloves:

6.1. Open the plastic cup containing the Raindrop Near Vision Inlay. Remove the inner cup, and identification labels from the outer plastic cup. Remove the seal of the inner cup and

transfer the glass vial containing the inlay onto a sterile field.

6.2. Assemble sterile syringe and cannula. Hold the cannula package so the heat seal is facing away from you. Gently snap the heat seal by applying pressure with both thumbs on the package in a direction away from you. Partially remove the syringe from blister pack exposing the syringe luer fitting. While being careful not to directly come into contact with the syringe, remove the non-sterile cannula cover exposing the sterile cannula hub. Twist the cannula hub onto the end of the syringe luer until tightly connected. Remove the cover from cannula exposing the sterile cannula. Place the sterile syringe cannula assembly onto the sterile field.

6.3. Snap off the plastic cover from the glass vial. Carefully pull the tab off the aluminum cap and peel away from vial. Remove the rubber stopper. Carefully remove the Raindrop Inserter from the glass vial using forceps. Do not touch the inserter cap on sides of the vial. 6.4. Attach the shaft of the Raindrop Inserter to the round open end of the Inlay Inserter Chuck

Handle. Refer to the Inlay Inserter Chuck Handle Instructions for Use (P/N 304-0040) for additional information.

6.5. Hold the chuck handle so that the inserter cap is facing upward. Carefully slide the tip of cannula needle through the hole in the cap until it seats on the tip of inserter. Using your thumb, retract the plunger of the syringe about half an inch (approx. 13 mm) and vertically withdraw the cannula and syringe while maintaining alignment with the center axis of the hole in the cap.

6.6. Maintaining the cap in the upward facing direction, firmly grasp the main body of the cap using forceps and pull the cap vertically to remove the cap from the inserter.

6.7. The Raindrop Near Vision Inlay is now ready for surgical delivery. The inlay should be delivered immediately to avoid dehydration.

7. Using a dry technique, position the Raindrop Inserter lightly on the stromal surface over the light-constricted pupil. Place the tip of a surgical instrument (e.g., Barraquer spatula, 30 gauge cannula, or equivalent) over the inlay visible through the slot of the Raindrop Inserter, and pull the inserter away, transferring the inlay to the stromal surface.

8. If necessary, further align the Raindrop Near Vision Inlay over the center of the light constricted pupil by using the surgical instrument.

9. Allow the inlay to adhere to the stromal surface by letting it dry before replacing the flap. When the Raindrop Near Vision Inlay is properly adhered, it will have a slightly dimpled appearance. Typically, it takes between 30 seconds to one (1) minute for the inlay to adhere properly to the stromal surface.

10. Reposition the flap using a small amount of BSS at the hinge of the flap and on the stromal surface of the flap. DO NOT irrigate under the corneal flap as this may move the inlay causing it to be misaligned, damaged, or lost.

11. Administer appropriate postoperative medications.

12. Conduct a slit lamp exam to ensure that the inlay is centered over the pupil and within the corneal flap.

13. Instruct the patient on the proper use and duration of postoperative medications.

14. Shield the eye prior to discharging the subject. Instruct the patient to continue to wear the protective shield during sleep for up to four (4) weeks after surgery.

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EMERGO EUROPE

Molenstraat 15 2513 BH, The Hague

Figure

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References

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