University of Rochester

Clinical Applications of The RochesterNomogram

Scott MacRae MD* Manoj Subbaram PhD,Geun Young Yoon PhD.

*Professor of OphthalmologyProfessor of Visual ScienceCenter for Visual ScienceUniversity of Rochester

University of Rochester

Dr. MacRae is a consultantto Bausch and Lomb

University of Rochester

The Problem – Hyperopic OvercorrectionCustomized LASIK

• Post-Custom LASIK refractive error– Incidence (FDA trial, n = 340 eyes) and range (+/- 2 D)– More over-correction than under-correction (9 X)

20 (5.9%)1 (0.2%)> 1 D

74 (21.8%)8 (2.3%)> 0.5 D

Hyperopia(over-correction)

Myopia(under-correction)

6 months postLASIK SE (D)

University of Rochester

Aberration InteractionCausing HyperopicOvercorrection?

University of Rochester

The Rochester Nomogram

• Unique features– Use of preoperative manifest refraction

• Preop myopia (vector notation: SE, J0, J45)• NOT PPR (wavefront sphere value)

– Derived from analysis on 112 myopic eyestreated by same surgeon with Zyoptix LASIK inFDA trial• Effect of preop HOA on postop refractive error

– Effect of Spherical Aberration– 3rd order aberration– Aberration Interaction

University of Rochester

Aberration Interaction: Preop HOA Influenceon Postop Sphere and Cylinder

trefoil coma coma trefoil

quadrafoil secondary spherical ab.

2nd

3rd

4th

Radialorder

secondary quadrafoil

defocusastigmatism astigmatism

astigmatism astigmatism

Z20Z 2

-2 Z22

Z 3-1 Z3

1Z 3-3 Z3

3

Z40 Z4

2Z 4-2 Z4

4Z 4-4

Lower OrderAberrations

Higher OrderAberrations

University of Rochester

The Rochester Nomogram - Methods

0.53 + 0.160.45 + 0.16Mean Preop HOA (um)

-0.81 + 0.70

(0 to -4.25)

-0.60 + 0.49

(0 to –3.25)

Mean Astigmatism (D)

-4.89 + 2.06

(-1 to –10.25)

-3.41 + 1.44

(-1.25 to –7.50)

Mean preop SE (D)

2.5% NeosynephrineFirst Study(175 eyes)

112 eye FDA StudyParameter

University of Rochester

The Rochester Nomogram:Eliminates Outliers

(N=175)

-0.50

-0.25

0.00

0.25

0.50

0.75

1.00

Sphere SE

Man

ifest

Refr

acti

on

(D

)

Rochester Nomogram

Zyoptix Algorithm

(- 1.04 to(- 1.04 to1.81 D)1.81 D)(+/- 1 D)(+/- 1 D)

-0.11-0.11

0.170.17

0.510.51

0.330.33

0.040.04 0.300.30

0.550.55

0.350.35

University of Rochester

The Rochester Nomogram – Results 0 Outliers > 1.00 D (N=175)

0

5

10

15

20

25

30

35

40

45

93% PPR

Num

ber o

f Eye

s

ROC93% PPR

2 Myopia2 Myopia12 Hyperopia12 Hyperopia

N = 175 eyesN = 175 eyes

SE > 1 DSE > 1 D0.5 < SE < 10.5 < SE < 1DD

10 Myopia10 Myopia5 Hyperopia5 Hyperopia

22.8%22.8%

13 Myopia13 Myopia27 Hyperopia27 Hyperopia

8.6%8.6% 8%8%

00

University of Rochester

The Rochester Nomogram – VA• 93.1% of the eyes had 20/20 or better UCVA• 98.3% of the eyes had 20/20 or better BCVA

University of Rochester

The Rochester Nomogram forPharmacologic vs Non Pharmacologic

Dilated Zyoptix

Scott M. MacRae MDManoj V. Subbaram BS Optom., PhD

Geun Young Yoon PhDUniversity of Rochester

&Ian Cox OD PhD

Bausch and Lomb

University of Rochester

Rochester Nomogram: Pharmacologic vs NonPharmacologic Dilated Zyoptix

• 175 eye 2.5%Neosynephrine DilatedZyoptix

• 90 eye Gulden Black Hood:low mesopic Zywaves

• 6.3 mm pupil diameterminimal (60.7% of eyescould be dilated to 6.3mm)

University of Rochester

Luminance/IlluminationPhotometry Testing

• Tectronics Lumicolor J17 Photometer/Radiometer• Rural Low Light Night Driving 0.15 Candellas/meter_• Zywave Maltese Cross 0.05 Candellas/meter_

(1/3 of night driving illumination)

University of Rochester

Results (ROC nomogram)

-0.63 to +0.50-1 to +1 DRange Sph Eq (D)

-0.08 + 0.23-0.11 + 0.341-month Sph Eq (D)

0.53 + 0.140.53 + 0.16Preop HOA (um)

-0.56 + 0.53-0.81 + 0.70Preop Cyl (D)

-4.11 + 2.04-4.52 + 2.05Preop Sphere (D)

-4.39 + 2.08-4.89 + 2.06Preop Sph Eq (D)

No Neosynephrine (90 eyes)

2.5% Neosynephrine(175 eyes)

Parameter

Standard Deviations of 0.34 or 0.23 D are close Standard Deviations of 0.34 or 0.23 D are close to the SD of manifest refraction repeatabilityto the SD of manifest refraction repeatability

BullimoreBullimore 0.2; 0.2; NizamNizam 0.33 D; 0.33 D; BlackhustBlackhust 0.28 D 0.28 D

University of Rochester

Zyoptix with Rochester Nomogram

Natural mesopicpupil (n = 90)

Pharmacologicaldilation (n =175)

97.8%91.4%71.4%Postop SE < +0.50D

-0.08 + 0.23(-0.63 to +0.50)

-0.11 + 0.34(-1 to +1)

+0.26 + 0.50(-1.04 to +1.81)

Postop SE (D)

94.6%93.1%89.3%Postop UCVA > 20/20

0.53 + 0.140.53 + 0.160.45 + 0.16Preop HOA (um)

-4.39 + 2.08-4.89 + 2.06-3.41 + 1.44Preop SE (D)

Rochester NomogramZyoptix FDA trial(112 eyes)

Parameter

Greater preopMYOPIA & HOA

Better postop VA and SE (both pharmacological dilation &natural mesopic pupil)

University of Rochester

Preop Coma and Postop Astigmatism

0.40 + 0.17 um0.26 + 0.43 umPreop coma

71/175 (40%)104 /175 (60%)Incidence

> 0.50 D< 0.50 DPostop Cyl

p < 0.0001

Ablation Decentration of Coma Induces Astig.

University of Rochester

Postop Astigmatism Risk Factor #2

• Treatment of preoperative Coma– Decentration of Laser ablation induces astigmatism

trefoil coma coma trefoil

defocusastigmatism astigmatismZ20Z 2

-2 Z22

Z 3-1 Z3

1Z 3-3 Z3

3 3rd order

2nd order

University of Rochester

Summary: Customized Ablation withRochester Nomgram

• Aberration Interaction is Important• Zyoptix Refinement: The Rochester Nomogram

– Reduces Outliers: < 1%, 4X’s less likely to have >0.5 D outlier– >93-94% 20/20 or Better Uncorrected Visual Acuity (UCVA) with

or without pharmacologic dilation– Cascade effect of HOA on sphere well compensated

• Further development by refining relationship betweenpreop 3rd order terms and postop astigmatism