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Phakic IOLs : Pros and Cons

ERIK L. MERTENS MD, FEBOphth.Physician CEO

Antwerp Private ClinicPresident-elect AECOS Europe

Financial disclosure : consultant Staar Surgical, PhysIOL, Allotex, Medicem, TearLab, MicroSurgical Technology, CapsuLaser,

Novoxel, CSO, Ellex

Points of Criticism....

• endophthalmitis

• sizing

• cataract

• IOP

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•

Strong Points....

• reversibility - removability

• predictability - stability

• quality of vision - optical zone size

• cornea and crystalline lens remain untouched• predictable calculations and high quality of vision

for future premium IOL implantations

•

Endophthalmitis• 0.0167% of cases (#17954)

• 3 reports, 2 with follow-up and full recovery• Staf. Epidermidis : no vision loss

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•

Prevention

• povidone iodine 15 and 3 min before surgery

✓ eyelid 10%

✓ ocular surface 5%

• 1 paracenthesis + 2.6 mm three step main incision• cefuroxime

• < 2 minutes

• No miotic agents

Factors Influencing Vault Height

• STS Diameter

• Special Sulcus or Iris Anatomy Prevents ICL from fully “Seating” in the Sulcus

• UBM scans dependent on:

– Cooperative Patient

– Operator Skill

– Interpretation by Surgeon

• Lens Rise

• Intraoperative : check position haptics and vault

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STS Nomogram

OCT - UBM

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Lens Rise

STS: 12.3

Rise: 480 µ

STS: 12.3

Rise : 1220 µ

740 Micron Difference!

Courtesy Dr. G. Parkhurst

New NomogramCurrent STS Nomogram

STS<11.0 use 12.111.1 to 12.2 use 12.612.3 to 12.9 use 13.2>13.0 use 13.7

If power of ICL is -3 to -7.5, go larger at threshold; if power -8 to -16, go smaller at threshold

My Current Nomogram

STS<10.8 use 12.110.8 to 11.7 use 12.611.8 to 12.9 use 13.2 >13.0 use 13.7

If Lens Rise <650 or >900, go to respective larger/smaller size when within 0.2 of the STS threshold*

*Account For Special Anatomy

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1%

17%

36%

22% 24%

1%

19%

43%

16%

20%

0%

26%

40%

15%

19%

0%

32%

37%

15%17%

0%

10%

20%

30%

40%

50%

0 - 100 100 - 350 350 - 600 600 - 750 >750

% o

f Ey

es

Vault (µm)

N=306

Vault

•

Instant Cataract Lens????

• Cataract 5,2%

✓ 43,4% in first year

✓ 15,4% 1-3 year

✓ 35,3% >3 year

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Meta-analysis and review : effectiveness, safety, and central port design of the intraocular collamer lens

M. Packer, Clinical Ophthalmology 2016:10 1059-1077

Data combined with Dr. Alfonso

•

Safety Evolution

V4 V4B V4c

N 2456 1976 1888

Cases of Cataract 21 12 0

% of cases with cataracts 0.86 % 0.61 % 0

Years of follow-up Up to 14 y Up to 6 y Up to 4 y

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Time from ICL to Cataract SurgeryAll in V4 Model

77 % at 4 years

Publication Follow UpN

(eyes)Cataract

PigmentDispersio

n

PupillaryBlock

SSI

Shimizu, Br J Ophthalmology 2012 Mar

6 months 20 0 0 0

Alfonso, J Cataract Refract Surg 2013 Jun

6 months 138 0 0 0 0

Gonzalez-Lopez, J Cataract Refract Surg 2013 Dec

1 month 100 0 0

Kamiya, J Cataract Refract Surg 2015 Jan

1 year 23 0 0 0 0

Alfonso, J Cataract Refract Surg 2015 Apr

6 months 781 0

Lisa, J Cataract Refract Surg 2015 Jun 1 year 147 0 0 0 0

Fernandez-Vigo, AJO 2016 3 months 50 0 0 0

Shimizu, Medicine 2016 Apr 5 years 32 0 0 0 0

Total 1291

•

Literature Review V4c Visian ICL

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IOP

•

Prevention

• V4c/EVO+ – Aquaport

• 1 hour postop IOP

• 250 mg acetazolamide PO

• methylcellulose • no miotic agents

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13.89

12.39

13.13

14.07

0.00

4.00

8.00

12.00

16.00

20.00

Pre 1 month 5 months 12 months

Intr

aocu

lar

Pre

ssu

re (

mm

Hg)

Follow-up Time

N=306

IOP

1469 V4c implants

306 with F-U > 4 yearParameter Mean±SD (range)

Age (years) 31.8±7.6 (19 to 45)

Sphere (D) -5.97±2.82 (-0.75 to -14.75)

Cylinder (D) -0.94±0.87 (0 to -4.25)

ACD (mm) 3.24±0.20 (2.80 to 3.71)

WTW (mm) 11.93±0.36 (11.00 to 12.70)

Scotopic Pupil (mm) 6.30±0.66 (4.5 to 7.75)

ECC (cell/mm2) 2421.2±271.2 (2235 to 2690)

IOP (mmHg) 13.84±3.38 (8 to 22)

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y = 1.0042x + 0.0131R² = 0.9992

-16

-14

-12

-10

-8

-6

-4

-2

0

2

-16-14-12-10-8-6-4-202

Attempted spherical Equivalent (D)

Ach

ieve

d S

ph

eri

cal

Equ

ival

en

t (D

)

N=306

Predictability

Cumulative UCVA

32%

91%

100%

57%

97% 99% 99% 99% 99% 100%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

20/12.5 20/16 20/20 20/25 20/32 20/40 20/63 20/80 20/100

Pro

po

rtio

n o

f ey

es

(%

)

Snellen Visual Acuity

Pre-op BCVA

Post-op UCVA

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-5.23

0.02 0.01 0.01 0.01

-10.00

-8.00

-6.00

-4.00

-2.00

0.00

2.00

Pre 1 month 3 months 6 months 12 months

Me

an S

ph

eri

cal E

qu

ival

en

t (D

)

N=306

Stability 4 year follow-up

Follow-up periods (years)

•

Quality of Vision

V4

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Evolution towards

EVO+ Visian ICL

V3 no

cartridge

loading forceps

UBM

toric ICL

V4cEVO+

Larger Optical Zone in Most Diopterswhile maintaining the same overall height

5.8 mm

6.1 mm

V4c -9.0 D

V5 -9.0 D

height

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Increased Optical Zone

4.800

5.000

5.200

5.400

5.600

5.800

6.000

6.200

-18.0 -15.0 -12.0 -9.0 -6.0 -3.0 0.0

Optic Diameter versus Power V5

V4C5.8 mm

6.1 mm

Increased Optical Zone

•

In daily life

• pupillometry magnifies pupil by 13%

• corneal OZ = 1.24 x optical Evo+ diameter

-6.0 D EVO+ ICL with 6.1 mm optic covers 6.9 mm pupil

6.1 mm optical diameter = 7.56 mm corneal OZ

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HD Quality Evo+ ICL

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•

Cornea and crystalline lens

remain untouched

• Related issues only for LVC

• Dry eye

• Ectasia• IOL calculation

• HOA and premium IOL implantation

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LASIK

ICL

Courtesy

Dr. R. Zaldivar

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LVC : Corneal complications

Lens Surgery

Better IOL calculations

No changes in corneal quality

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Conclusions

• The EVO+ Visian ICL is safe, effective, and predictable in correcting low, moderate and high degrees of myopia, hyperopia and astigmatism

• Superior HD quality vision

• No dry eye issues

• Cornea and lens unaltered for future options

• Potential complications low in incidence

Thank you