Prospective Nonrandomized Prospective Nonrandomized Comparison of Different OVD´s in Comparison of Different OVD´s in Non-eventful PhacoemulsificationNon-eventful Phacoemulsification

ASCRS, 2008ASCRS, 2008Fernando Aguilera MDFernando Aguilera MD

NO FINANCIAL INTERESTNO FINANCIAL INTEREST

Introduction

OVD´s protection and space formation have allowed phaco to be the prefered method for cataract extraction in normal and complex cases

OVD´s clasification is based in numerical values of: zero shear viscosity and cohesionzero shear viscosity and cohesion

(Arshinoff;JCRS2005;31:2167-2171)

Ovd’s clasificationOvd’s clasification

Low Viscosity Low Viscosity DispersiveDispersive

ViscoadaptiveViscoadaptivess

andandSuperviscous Superviscous

CohesivesCohesives

ViscousViscousCohesiveCohesive

DisDisCoCoVisViscc™™

Viscoat®

Cellugel®

Ocucoat®

Healon®-GVHealon®-5

Healon®

Provisc®

Amvisc®

ViscoViscoDispersivDispersiv

ee

usa market ovd´s

objectiveobjective

Compare clinical results and machine Compare clinical results and machine parameters between different OVD´s in phacoparameters between different OVD´s in phaco

Viscodispersive:………… DiscoviscViscodispersive:………… Discovisc Viscoadaptive:…...……… Healon 5Viscoadaptive:…...……… Healon 5 Cohesive:…………………Biovisc , Amvisc PlusCohesive:…………………Biovisc , Amvisc Plus Combination (Di-Co)…… DuoviscCombination (Di-Co)…… Duovisc

Material and methodsprospective, comparative, nonrandomized

Data 200 patients non complicated M.C.T. phaco Same surgeon (FAZ) Infiniti OZiL, Intrepid FMS, 30° miniflared Kelman tip, Blended torsional-conventional burst phaco Pre-postop: complete ophthalmic exam ECC,PM,IOPEVALUATION (SUBJECTIVE)Transop: questionarie for each case of ovd transoperative behavior EVALUATION (OBJECTIVE):Measurement of CDE (cumulative delivered energy)

Measurement of BSS (electric weight with double pole extension)

1.-Phaco 2.-Cortex I/A 3.- Asp post-IOL implanation1.-Phaco 2.-Cortex I/A 3.- Asp post-IOL implanation

Postop. Evaluations : 1,7,30.60 days, including: ECC,PM,IOP,Postop. Evaluations : 1,7,30.60 days, including: ECC,PM,IOP,

Transoperative OVD behavior evaluation:1- Ease of injection2- Visibility 3- Pupil manipulation4- AC maintainance (ccc, Phaco) 5- IOL implantation 6- I/A post IOL

Mean Surgical Difficulty by OVD

0

1

2

3

Cataract Extraction IOL Insertion Overall

Dif

ficu

lty

Lev

el

DisCoVisc DuoVisc BioVisc Healon5 AmviscPlus

Results : subjective

Mean Ease of Injection and Visualization Post Injection1=Poor 2=Fair 3=Good 4=Excellent

0

1

2

3

4

DisCoVisc DuoVisc BioVisc Healon5 AmviscPlus

Lev

el o

f E

ase

Injection Visualization

Anterior Chamber Maintenance During Surgical Phases

0

1

2

3

4

5

Anterior Capsulotomy Phacoemulsification IOL Insertion

Mai

nte

nan

ce S

cale

DisCoVisc DuoVisc BioVisc Healon5 AmviscPlus

Mean Ocular Inflammation 1 Day Postoperatively

0

1

2

3

Edema Cell Flare

Infl

amm

atio

n L

evel

DisCoVisc DuoVisc BioVisc Healon5 AmviscPlus

Results objective

Percent of ECC Loss Pre- to 2 Months Post-Operatively

0

5

10

15

20

25

30

DisCoVisc DuoVisc BioVisc Healon5 AmviscPlus

Per

cen

t L

oss

Mean Endothelial Cell Count Pre- and Post-Operatively

0

500

1000

1500

2000

PreOp 1 Month Post 2 Months Post

cells

/mm

2

DisCoVisc DuoVisc BioVisc Healon5 AmviscPlus

Mean Pachymetry Pre- and Post-operatively

500

520

540

560

PreOp 1 Month Post 2 Months Post

um

DisCoVisc DuoVisc BioVisc Healon5 AmviscPlus

2 Months Postop: % ECC Loss by CDE Level (All OVDs)

0

10

20

30

40

50

<5.0 >5 to <10 >10 to <15 >15 to <20 >20

CDE Range

% E

CC

Lo

ss

p = 0.0290

Note: A statistically significant difference (p = 0.0290 ) was found for % ECC loss by CDE level.

2 Month Postop: % ECC Loss by CDE Level

-10

0

10

20

30

40

50

60

<5.0 >5 to <10 >10 to <15 >15 to <20 >20

CDE Range

EC

C L

os

s

DisCoVisc DuoVisc BioVisc Healon5 AmviscPlus

2 Month Postoperative: ECC Loss by BSS Volume

-10

0

10

20

30

40

50

60

70

?100 101-200 201-300

BSS Volume (mL)

cells

/mm

2

DisCoVisc DuoVisc BioVisc Healon5 AmviscPlus

ECC Loss by CDE and BSS Levels

0

10

20

30

40

50

<5.0 >5 to <10 >10 to <15 >15 to <20 >20

CDE

cell

s/m

m2

?100 101-200 201-300

2 Months Postoperatively: Percent ECC Loss by Preoperative ECC

-10

0

10

20

30

40

ECC <1500 Preop ECC >1500 Preop

Per

cen

t L

oss

All OVDs DisCoVisc DuoVisc BioVisc Healon5 AmviscPlus

BioVisc Healon5 AmviscPlus

DisCoVisc* p < 0.05 p < 0.05 p < 0.05

DuoVisc* p < 0.05 p < 0.05 p < 0.05

AmviscPlus* p < 0.05

Note: * indicates OVD with statistically significantly less ECC loss per Tukey’s studentized range test .

% ECC Loss Preop to 2 Months Postop: Statistically Significant Pairs

Discusion

Higher energy of US was related to more ecc loss (CDE > 10)

Higher levels of BSS were related to more ecc loss ( > 100 ml)

Overall the Viscodispersive OVD (Discovisc) cataract cases had better clinical and subjective outcomes

Conclusion

Viscodispersive (Discovisc) and Dispersive-Cohesive combination (Duovisc) OVD´s produced less ECC loss and Corneal edema in Microcoaxial Torsional Phacoemulsification than Viscoadaptive and viscous cohesive OVD´s (statistically significant)(statistically significant)

Cohesive OVD´s were related to more ECC loss in harder cataracts and should not be used in grades 4 and above (worst case 49% loss)

Viscodispersive OVD´s (Discovisc) are indicated in any grade of cataract hardness

Thank you

Fernando Aguilera MD

Mean Number of OVD Vials Utilized per Case

0

0.5

1

1.5

2

2.5

DisCoVisc DuoVisc BioVisc Healon5 AmviscPlus

Via

l N

um

be

r

Mean Infiniti CDE Reading by OVD

0

2

4

6

8

10

DisCoVisc DuoVisc BioVisc Healon5 AmviscPlus

CD

E

Mean Grade of Cataract by OVD1=Soft 2=Medium 3=Hard 4= Brittle

0

1

2

3

4

DisCoVisc DuoVisc BioVisc Healon5 AmviscPlus

Gra

de

Mean Estimated Percent of OVD Retention

0

3

6

9

12

15

DisCoVisc DuoVisc BioVisc Healon5 AmviscPlus

Per

cen

t

Mean Capsural Bag Maintenance During Surgery1=Poor 2=Fair 3=Good 4=Excellent

0

1

2

3

4

DisCoVisc DuoVisc BioVisc Healon5 AmviscPlus

Mai

nte

nan

ce S

cale

Mean Difficulty of OVD Aspiration1=Very Easy 2=Easy 3=Neither Easy or Difficult 4=Difficult 5=Very Difficult

0

1

2

3

4

5

DisCoVisc DuoVisc BioVisc Healon5 AmviscPlus

Dif

ficu

lty

Lev

el

Mean Effectiveness of Pupil Expansion1=Not Effective 2=Moderately Effective 3=Very Effective

0

1

2

3

DisCoVisc DuoVisc BioVisc Healon5 AmviscPlus

Eff

ec

tiv

en

es

s L

ev

el

Mean Intraocular Pressure 1 Day Postoperatively

0

5

10

15

20

DisCoVisc DuoVisc BioVisc Healon5 AmviscPlus

mm

Hg

Percent ECC Loss by Cataract Grade: Preop to 2 Month Postop

-10

0

10

20

30

40

1 2 3 4

Cataract Grade

Per

cen

t

DisCoVisc DuoVisc BioVisc Healon5 Amvisc Plus

Percent ECC Loss by Cataract Grade: Preop to 2 Month Postop

0.00

10.00

20.00

30.00

40.00

1 2 3 4

Cataract Grade

Per

cen

t

DisCoVisc DuoVisc BioVisc Healon5 Amvisc Plus

Note: No statistical difference exists (p = 0.5489) in % ECC loss by cataract grade.

(p = 0.5489)

2 Months Postop: % ECC Loss by CDE Level (All OVDs)

0

10

20

30

40

50

<5.0 >5 to <10 >10 to <15 >15 to <20 >20

CDE Range

% E

CC

Lo

ss

2 Month Postop: % ECC Loss by CDE Level

0

10

20

30

40

50

<5.0 >5 to <10 >10 to <15 >15 to <20 >20

CDE Range

EC

C L

oss

DisCoVisc DuoVisc BioVisc Healon5 AmviscPlus

MCTo ECC: MCTo ECC: 8% 8% < ToSt / < ToSt / 16% 16% < Trphaco< TrphacoMCTo Pach: >< ToSt / MCTo Pach: >< ToSt / 16% 16% < Trphaco< Trphaco

9.6% 8.9%8.1%

5.2%4.0% 4.1%

0.0%

2.0%

4.0%

6.0%

8.0%

10.0%

LONGITUD. (106 Surgeries)

TORSIONAL (102 Surgeries)

TORS'L+ULTRA(102 Surgeries)

Patient Outcome Parameter Comparison

Pachymetry (% increase inthickness)Endothelium CellLoss (% cell loss)

TORSIONAL VS LINEARTORSIONAL VS LINEAR

Literature : Less Ultrasound energy and BSS used Literature : Less Ultrasound energy and BSS used during phaco diminishes the risk for endothelial cell during phaco diminishes the risk for endothelial cell loss and corneal burnsloss and corneal burns

Ernest P, Rhem M, Mc Dermott M et al. Phacoemulsification conditions resulting in thermal wound injury. J Cataract Refract Surg 2001; 27:1829-1839

DeBry P, Olson RJ, Candall AS. Comparison of energy required for phaco chop and divide and conquer phacoemulsification. J Cataract Refract Surg 1998; 24:689-692

Dick HB, Kohen T, Jacobi FK, et al. Long term endothelial cell loss folowing phacoemulsification through a temporal clear corneal incision. J. Cataract Refract Surg 1996; 22:63-71