CLINICAL GUIDELINESMini WELL Ready and Mini WELL Toric Ready

EXTENDING THEIR HORIZONSGIVE YOUR PATIENTS UNINTERRUPTED HIGH-QUALITY VISION

VISIONUNINTERRUPTED

Mini WELL Ready and Mini WELL Toric Ready are premium, extended depth of focus (EDOF) intraocular lenses (IOLs) based on a patented

innovation which generates one continuous, extended focus for sharp vision from far to near, going beyond what is currently possible with

multifocal IOLs.1,2

Mini WELL has demonstrated consistent visual performance

with a lower risk of halos and glare compared to monofocal

IOLs, combined with good contrast sensitivity.4,5

In your appropriately selected patients, you can now have

confidence in offering uninterrupted, high-quality vision

at all distances and at all times.6

The extended depth of focus is created by inducing targeted

amounts of spherical aberration in concentric optical zones

generating a longitudinally extended continuous focal point1,3

MINI WELL - DESIGNED TO DELIVER TRUE EXTENDED DEPTH OF FOCUS FOR HIGH-QUALITY VISION

• Patient selection and expected results

• Pre-operative assessment: - biometry - topography - IOL calculation - refracting target

• Intra-operative tips

• Post-operative management

IN THIS USER GUIDE:

Wavefront EngineeredLens Side View

Light

ExtendedFocus

Focal length

No glasses, or for only a little bit of the time*

Average contrast sensitivity tested with sine-wave gratings within normal limits at all spatial frequencies

Reading fluency (>80 wpm) without correction

95% at 0.5 LogRAD (i.e. A5 booklet)

69% at 0.3 LogRAD(i.e. telephone directory)

No IOL explantation/replacement due to subjective intolerance of visual symptoms

75%No halos

81% No glare

97% Far

94%Intermediate

75% Near

A period of 4-8 weeks might be needed to allow for neuroadaptation

Patients considering implantation of a presbyopia-correcting IOL need

to be aware that there are potential benefits and trade-offs associated

with the technologies available.

Selecting the right Mini WELL and Mini WELL Toric candidate improves

success of implantation. This means understanding your patients’

lifestyles, which does require chair time and effective communication

and education.6

In particular:

Mini WELL Ready has been designed for continuous vision at all distances in the range of infinity to near (40 cm) distance with 20/25, or better, visual acuity.5 In order to achieve the best results, it is recommended to implant MINI WELL bilaterally.

PATIENT CANDIDATES FOR MINI WELL AND EXPECTATIONS

*Inform patients that they may still need to wear glasses for some activities such as to read very small letters.

IN THE FOCUS CLINICAL TRIAL, MINI WELL DEMONSTRATED:5

• The patient must have realistic expectations

• The patient must have a very strong motivation

• The patient must not have psychological problems

• The patient must understand optical and visual limitations

• The patient must understand the concept of neuroadaptation

Pupil abnormalities:• Non-reactive, extremely small pupils under photopic conditions (i.e.

<3 mm in a room with light range of 80 to 160 cd/m2), tonic pupils

that do not dilate under mesopic/scotopic conditions, abnormally

shaped pupils or abnormally positioned pupils. Pupillary dynamics

of patients should, however, always be examined.

Mini WELL and Mini WELL Toric should not be used if one of the following eye pathologies exists:• Choroidal haemorrhage, concomitant severe eye disease, extremely

shallow anterior chamber, medically uncontrolled glaucoma,

microphthalmos, proliferative diabetic retinopathy, severe corneal

dystrophy, severe optic nerve atrophy, amblyopia, macular disease,

severe dry eye, significant irregular corneal aberration.

Mini WELL and Mini WELL Toric should not be used if one of the following corneal abnormalities exists:• Irregular corneal astigmatism, keratoconus, keratoglobus, keratolysis,

keratomalacia, keratomycosis, corneal plana, Fuchs’s dystrophy or

cornea guttata.

Mini WELL and Mini WELL Toric should not be used if one of the following vitreous pathologies exists:• Asteroid hyalosis, synchysis scintillans, vitreous amyloidosis, vitreous

haemorrhage.

Other conditions for which careful medical judgment should be exercised:Prior corneal refractive or intraocular surgery, zonular laxity, recurrent

inflammation of anterior or posterior segment of unknown aetiology

(chronic uveitis), paediatric patients, suspected microbial infection,

bilateral congenital cataracts, history of retinal detachment or

susceptibility to this condition, monocular patients, pregnancy.

MINI WELL PATIENT SELECTION – UNSUITABLE CANDIDATES

Mini WELL is suitable for a wide range of patients. However, the safety and effectiveness of Mini WELL IOLs have not been established in

patients with the following conditions and careful medical judgement should be exercised in such cases.

For additional safety information, please see the Mini WELL Instructions for Use.

BIOMETRY Use an optical biometer to measure the axial length of the eye of

people having cataract surgery. Ensure that measurements are

reliable with a device that is calibrated on a regular basis.

Proper fixation is essential as is having the patient look directly at

the red light since the instrument measures along the visual axis.

Repeat measurements three- to five-times as necessary.

Repeat the measurement if:7

• Axial length is <22.0 mm or >25.0 mm• Average corneal power is <40.0 D or >47.0 D• Difference of corneal astigmatism between eyes is >1.0 D• Difference of axial length between eyes is >0.3 mm• Difference of calculated emmetropic IOL power is >1.0 D

If not confident with these measurements, consider using another

device and compare the results (e.g. IOL Master and Lenstar).

For highly myopic eyes (axial length >28.0 mm) optical biometry

is usually reliable if the patient can fixate accurately. If ultrasound

measurements are being performed, a B-scan should be used to

determine the presence or absence of staphyloma.8

TOPOGRAPHYTopography is helpful to identify irregular astigmatism. Depending

on the device used (e.g. Cassini, Pentacam, Galilei), posterior

corneal astigmatism or total corneal astigmatism can also be

measured.

• If the corneal astigmatism is <0.75 D, it is recommended to select Mini WELL Ready

• If the corneal astigmatism is ≥0.75 D, it is recommended to select Mini WELL Toric Ready

PRE-OPERATIVE ASSESSMENT

For additional safety information, please see the Mini WELL Instructions for Use.

PRE-OPERATIVE ASSESSMENT

IOL CALCULATION FORMULASUse a fourth-generation formula, such as Barrett’s Universal II

formula.9

Alternatively, consider choosing one of the following formulae

according to the recommended axial length range:8

• Haigis or Hoffer Q formulae for axial lengths ≤22.0 mm;• An average of SRK/T, Holladay I and Hoffer Q for axial lengths

>22.0 to ≤24.5 mm;• Holladay I for axial lengths >24.5 to ≤26.0 mm;• SRK/T for axial lengths >26.0 mm.

Personalise and optimise the Mini WELL Ready and Mini WELL

Toric Ready A-constant based on your surgical techniques and

equipment, experience with the lens model and post-operative

results.

Suggested constants for the IOL calculation with optical biometry devices are the following:

OP

TIC

AL

BIO

ME

TR

Y D

EV

ICE

S CONSTANTS

BARRETT OLSEN HOFFER Q HOLLADAY I SRK/T HAIGIS

*LF = 1.75*DF = -1.0

C: 0.39

ACD: 4.62pACD = 5.45 sf = 1.67 A = 118.82

a0 = -2.796

a1 = 0.3055

a2 = 0.2861

In case of Ultrasound biometry, the suggested IOL’s A-constant

is 118.6. Be aware that in patients with long eyes there may be

hyperopic surprises.

To reduce hyperopic outcomes, you may consider adjusting

the axial length (AL) according to the following Wang-Koch

formulas:10,11

IOL calculation formula ADJUSTMENT FORMULA

Application range

SRK/T Axial length adjusted = (0.8453 x measured AL) + 4.0773 AL > 27.0 mm

Holladay I Axial length adjusted = (0.817 x measured AL) + 4.7013 AL > 26.5 mm

Hoffer Q Not suggested for long eye NA

Haigis No axial length adjustment needed NA

The Haigis formula has 3 optimised lens constants (one specifically

related to AL), and no additional AL adjustment should be

performed. When using the Barrett Universal II and Hill-Radial Basis

Function formulas, no axial length adjustment should be used.11

Note: This method is not used for patients with prior refractive surgery as the calculation algorithms have already been optimised for long axial lengths and adding this correction will give a myopic result. Do not adjust the axial length in the setting of prior ALK, RK, LASIK and PRK.12

LF = lens factorDF = design factor

When using Mini WELL Toric Ready, it is recommended to use the

Mini Toric Calculator (http://www.Minitoriccalculator.com), which

gives three options:

1. Use anterior corneal power measurement only. This calculation method uses only the standard keratometry measurements (anterior corneal surface K readings) to calculate the lens.

2. Apply Abulafia-Koch adjustment that compensates for posterior corneal astigmatism. The Abulafia-Koch adjustment estimates the total corneal power using the anterior corneal power measurements and has been shown to give very similar results to the Barrett Calculator which also estimates the total corneal power.13

3. Use measured total corneal astigmatism. If you have an instrument (e.g. Scheimpflug camera) which measures directly the total corneal astigmatism, then mark this option. This option allows you to enter the value and meridian of the measured total corneal astigmatism.

Mini Toric Calculator is very reliable because it allows you to consider

also the posterior corneal surface.

REFRACTING TARGETTarget for emmetropia in both eyes. Should you need to adjust the

fellow eye’s target refraction, consider that when targeting the 1st

minus, patients may have slightly lower distance vision and near

vision would be better; when targeting the 1st plus, patients may

have better distance vision and slightly less near vision.

-0,20

-0,10

0,00

0,10

0,20

0,30

0,40

0,50

0,60

0,70

0,80

0,90

1,00

LOGMAR

Defocus

HYPEROPIC SHIFT MYOPIC SHIFT

+2,0 D -5,0 D-4,5 D-4,0 D-3,5 D-3,0 D-2,5 D-1,5 D -2,0 D-1,0 D-0,5 D+0,0 D+1,0 D +0,5 D+1,5 D

VISIONUNINTERRUPTED

INTRA-OPERATIVE TIPS

1. Savini G, et al. Visual performance of a new extended depth-of-focus intraocular lens compared to a distance-dominant diffractive multifocal intraocular lens. J Cataract Refract Surg. 2018;34(4):228-35. 2. Savini G, et al. Functional assessment of a new extended depth-of-focus intraocular lens. Eye (Lond). 2019 Mar;33(3):404-10. 3. Bellucci R, Curatolo MC. A new extended depth of focus intraocular lens based on spherical aberration. J Cataract Refract Surg. 2017;33(6):389-94. 4. Bellucci R, et al. Clinical and aberrometric evaluation of a new extended depth-of-focus intraocular lens based on spherical aberration. J Cataract Refract Surg. 2019;45(7):919-26. 5. Focus Study, Study code PSM15, data on file, SIFI. 6. Braga-Mele R, et al. Multifocal intraocular lenses: Relative indications and contraindications for implantation. J Cataract Refract Surg. 2014;40:313-22. 7. Holladay JT, et al. A three-part system for refining intraocular lens power calculations. J Cataract Refract Surg. 1988;14:17-24. 8. The Royal College of Ophthalmologists. Cataract Surgery Guidelines. Available at: https://www.rcophth.ac.uk/wp-content/uploads/2014/12/2010-SCI-069-Cataract-Surgery-Guidelines-2010-SEPTEMBER-2010-1.pdf [accessed 12 June 2019]. 9. Melles RB, et al. Accuracy of intraocular lens calculation formulas. Ophthalmology 2018;125(2):169-78. 10. Wang L, et al. Optimizing intraocular lens power calculations in eyes with axial lengths above 25.0 mm. J Cataract Refract Surg. 2011;37(11):2018-27. 11. Wang L, Koch DD. Modified axial length adjustment formulas in long eyes. J Cataract Refract Surg. 2018; 44(11):1396-97. 12. Hill W. High to extreme axial myopia - IOL power calculations: Available at: https://www.doctor-hill.com/iol-main/extreme_axial_myopia.htm [accessed 1 July 2019]. 13. Abulafia A, et al. New regression formula for toric intraocular lens calculations. J Cataract Refract Surg. 2016;42(5):663-71. 14. Nishi Y, et al. Reproducibility of intraocular lens decentration and tilt measurement using a clinical Purkinje meter. J Cataract Refract Surg. 2010;36:1529-35. 15. Chang D H, Waring G O IV, The subject-fixated coaxially sighted corneal light reflex: A clinical marker for centration of refractive treatments and devices. Am J Ophthalmol. 2014;158(5):863-74. 16. Wilkinson ME. Plus and minus cylinder subjective refraction techniques for clinicians: General refraction techniques. UIHC Department of Ophthalmology and Visual Sciences, January 2016. Available at: https://webeye.ophth.uiowa.edu/eyeforum/video/Refraction/pdfs/Std-subj-Refract-Plus-MinusCyl-Clinicans.pdf [accessed 2 August 2019].

A consistent curvilinear capsulorhexis is essential for centration

and accurate effective lens position. Avoid any irregularities

and decentration of capsulorhexis. Use Purkinje images

for IOL centration.14,15

Move the Mini WELL Ready IOL until the lens is correctly centred.

After implantation of the Mini WELL Ready IOL, remove all OVD

including behind the lens.

POST-OPERATIVE MANAGEMENT

AUTO-REFRACTION MEASUREMENT IS NOT SUGGESTED FOR MINI WELL READY BECAUSE IT COULD LEAD TO INACCURATE RESULTSAuto-refractors, including aberrometers, may yield erroneous

refractive results. For this reason, it is recommended to always

perform a manifest refraction.

FOR MORE ACCURATE POST-CATARACT REFRACTION, USE THE “MAXIMUM PLUS” REFRACTION TECHNIQUEBecause of the elongated focus of the Mini WELL Ready IOL,

manifest refraction has to be performed using the maximum plus

refraction technique (“push plus”):16

1. Check the visual acuity of the patient without correction.

2. Start by adding +1.50 D and assess visual acuity.

3. Proceed by decreasing in steps of -0.25 D until the patient sees the highest number of letters with the least amount of minus (this will be the maximum plus refraction).

4. Confirm by reducing another -0.25 D or two and visual acuity should remain the same.

Sep 2019 0123 Cod. 7100644MED For exclusive use by healthcare professionals