July/August 2002
`
`
`
`Volume 18, Number 4
`
`Jo rnal
`of
`ract1ve
`Surgery
`
`
`
`Official Publication of the International Society of Refractive Surgery
`
`
`
`
`
`
`
`
`
`Orlal■I Artlcla
`
`Aberration-sensing and Wavefront-guided Laser in situ Keratomileusls:
`
`
`
`Management of Decentered Ablation
`
`
`
`Michael Mrochen, Ronald R. Krueger,
`
`
`
`
`
`
`
`Michael Bueeler, Theo Seiler ............................................. .418
`
`
`
`laser in situ Keratomileusls for Hyperopia and Hyperoplc Astigmatism Using
`
`
`
`
`
`the Meditec MEL 70 Spot Scanner
`
`
`
`
`
`
`
`
`Klaus Ditzen, Joachim Fiedler, Stefan Pieger .................................................................................. 430
`
`
`
`
`
`Laser In situ Keratomileusis for Correction of Hyperopia and Hyperoplc Astigmatism
`
`
`
`
`With the Technolas 117C
`
`
`
`
`
`
`
`Jingcai Lian, Wen Ye, Deyou Zhou, Kangsun Wang ........................................................................ 435
`
`Factors That Affect Corneal Flap Thickness With the Hansatome Mlcrokeratome
`
`
`
`
`
`
`
`
`
`
`Raymond P. Gailitis, Mara Lagzdins ............................................................................................... .439
`
`
`
`Importance of Accurate Retractor Vertex Distance Measurements
`
`
`
`
`
`Richard A. Weiss, William Berke, Larry Gottlieb, Peter Horvath .................................................... 444
`
`
`
`
`
`
`Clinical
`
`Prior to Refractive Surgery
`
`
`
`
`
`
`
`
`Correlation Between Automated and Subjective Refraction Before and After
`
`
`
`
`
`
`Photorefractive Keratectomy
`
`
`
`
`
`
`
`
`
`Nicola Rosa, Attilio lura, Mary Romano, Gianluca Verolino, Antonio Romano ............................. .449
`
`
`
`An Informal Satisfaction Survey of 200 Patients After laser in situ Karatomileusis
`
`
`
`
`
`
`
`John C. Hill ..................................................................................................................................... .454
`
`Anterior CDrneal Surface After Nidek EC-5000 Multipass and Multizone
`
`
`
`
`
`
`
`Photorefractive Keratectomy for Myopia
`Nicola
`
`
`
`
`
`
`
`
`
`Rosa, Michele Lanza, Giuseppe De Rosa, Antonio Romano ............................................... .460
`
`
`
`
`
`Enlargement of the Temporal Clear Corneal Cataract Incision to Treat
`
`
`
`
`
`Pre-existing Astigmatism
`
`
`
`
`
`
`
`Sanjay N. Rao, Alexandra Konowal, Allison E. Murchison, Randy J. Epstein ................................. .463
`
`
`
`
`
`of Prophylactic Brlmoni�ine on Bleeding Complications and Flap Adherence
`
`
`
`
`
`Effect
`After Laser in situ Keratomileusis
`
`
`
`
`
`Richard A. Norden ......................................................................................................................... .468
`
`Changes in lntraocular Pressure After Laser In situ Keratomileusls for Myopia,
`
`
`
`
`
`
`
`Hyperopla, and Astigmatism
`
`
`
`
`Luz M. Agudelo, Carlos-A. Molina, Diego L. Alvarez ..................................................................... .472
`
`t
`
`Iatrogenic Keratectasla Following Laser in situ Keratomileusis
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Leopoldo Spadea, Giampiero Palmieri, Luigi Mosca, Romina Fasciani, Emilio Balestrazzi ........... .475
`
`
`
`�ISTED IN INDEX MEDICUS, CURRENT CONTENTS, OPHTHALMIC LITERATURE, EMBASE/EXCERPTA MEDICA
`
`
`
`
`
`
`
`
`Published for the Society by Slack Incorporated
`
`
`
`IContents inside I
`
`continued
`
`SLAYBACK EXHIBIT 1006
`
`Page 1 of 7
`
`

`

`��
`
`""
`
`2002
`
`Volume 18, Number 4
`
`Journal
`IOI . S
`
`e ract1ve urgeryJuly/August
`
`
`
`Official
`
`
`
`Publication of the International Society of Refractive Surgery
`
`Original Articles
`
`Aberration-sensing and Wavefront-guided Laser in situ Keratomileusis:
`
`
`
`
`Management of Decentered Ablation
`Michael Mrochen, PhD; Ronald R. Krueger, MD, MSE; Michael Bueeler; Theo Seiler, MD, PhD ........................................... .418
`
`
`
`
`
`
`
`
`LASIK ablations Using the WaveLight laser guided by data from an aberrometer, two eyes with decentered
`
`
`
`
`
`
`
`
`
`demonstrated postoperative piano refractions, improvements in visuatacuity, improvements of 1 to 5 linesof
`
`
`
`
`uncorrected visual acuity, and a 33% decrease in higher order aberrations.
`
`
`
`
`
`
`
`Laser in situ Keratomileusis for Hyperopia and Hyperopic Astigmatism Using the Meditec MEL 70
`
`
`
`
`Spot Scanner
`Klaus Ditzen, MD; Joachim Fiedler, MSc; Stefan Pieger, MSc ................................................................................................ 430
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Using a Meditec MEL 70 G-scan laser to correct spherical equivalent refractirte errors ranging from +2. 1_3 to +9.63 D
`
`
`
`
`in 23 eyes, for the group with hyperopia up to +6.00 D, all eyes were within ±0.50 D for spherical hyperopia and 52%
`
`
`
`
`
`
`for hyperopic astiginatism. Corrections greater than +6.00 D should not be attempted with this technology.
`
`
`
`Laser in situ Keratomileusis for Correction of Hyperopia and Hyperopic Astigmatism
`
`
`
`
`
`
`With the Technolas 117C
`Jingcai Lian, MD; Wen Ye, MD; Deyou Zhou, MD; Kangsun Wang, MD ............................................................................... .435
`
`
`
`
`
`
`
`
`
`
`Fifty-four eyes with hyperopia between + 1.00 and +6.00 D received LASIK using the Technolas 11 ?C, resuWng in
`
`
`
`
`
`
`61% of the spherical equivalent refraction within ±0.50 D and 63% with 20/20 or better spectacle-corrected visual
`acuity at 1 year after surgery.
`
`Raymond P. Gailitis, MD; Mara Lagzdins, BA ........................................................................................................................ 439
`
`Factors That Affect Corneal Flap Thickness With the Hansatome Microkeratome
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`value on the 40 µm thinner than the stated The Baush & Lomb Hansatome created flaps approximately
`
`
`
`
`thickness plate, with a variable range of thickness on the order of 100 µm.
`
`Clinical Importance of Accurate Refractor Vertex Distance Measurements Prior to Refractive Surgery
`
`
`
`
`
`
`
`
`
`
`
`
`
`Richard A. Weiss, MD; William Berke, OD; Larry Gottlieb, OD; Peter Horvath, OD ................................................................ 444
`
`
`
`
`
`
`that vertex distance T he vertex distance for a phoropter varied from 1 O to 34 mm in 189 eyes, suggesting
`
`
`
`
`-· measurements should be made in each refractive surgery patient.
`
`Correlation Between Automated and Subjective Refraction Before and After
`
`
`
`
`
`
`
`
`
`Photorefractive Keratectomy
`Nicola Rosa, MD; Attilio lura, MD; Mary Romano, MD; Gianluca Verollno, MD; Antonio Romano, MD ................................ 449
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`In a series of 159 eyes, there was good correlation between manifest refraction and automated refraction
`
`
`
`
`before PRK, but a poor correlation after PRK. Autorefractometry is unreliable In eyes after PRK.
`
`An Informal Satisfaction Survey of 200 Patients After Laser in situ Keratomileusis
`
`
`
`
`
`
`
`John C. Hill, MD, FRCS .......................................................................................................................................................... 454
`
`
`
`
`
`
`Of 200 patients (191 with bilateral surgery) that had LASIK with preoperative refractions ranging from -1.50 to
`
`
`
`
`
`
`
`-12.00 D, 95% wore no distance optical correction; 99% said they would have the procedure again, and 7.5%
`
`
`
`
`
`stated their night vision problems were considerably worse than before LASIK.
`
`Anterior Corneal Surface After Nidek EC-5000 Multipass and Multizone
`
`Nicola Rosa, MD; Michele Lanza, MD; Giuseppe De Rosa, MD; Antonio Romano, MD ........................................................ 460
`
`
`
`
`
`
`
`Photorefractive Keratectomy for Myopia
`
`
`
`
`
`
`
`
`
`
`
`In a series of 62 eyes that received PRK for myopia with a multipass, multizone program using
`
`
`
`
`
`the Nidek EC-5000 laser, postoperative topographic irregularities did not relate to the amount of treatment
`
`or the number of ablation zones.
`
`SLAYBACK EXHIBIT 1006
`
`Page 2 of 7
`
`

`

`
`
`(Table of Contents continued)
`
`
`
`Enlargement of the Temporal Clear Corneal Cataract Incision to Treat Pre-existing Astigmatism
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sanjay N. Rao, MD; Alexandra Konowal, DO; Allison E. Murchison, MD; Randy J. Epstein, MD ......................................... .463
`(
`
`
`
`
`
`
`In 14 eyes with mean pre·cataract removal refractive astigmatism of 2.10 D, enlarging the cataract wound
`
`
`
`
`
`to 4.5 mm produced a vector corrected reduction in cylinder of a mean 0.93 D. In seven eyes. with a mean preoperative
`
`
`
`
`
`
`
`cylinder of 2.85 D, enlarging the cataract wound to 5.5 mm produced a vector corrected reduction in astigmatism
`of a mean 1.34 D.
`
`Effect of Prophylactic Brimonidine on Bleeding Complications and Flap Adherence After
`
`
`
`
`
`
`
`
`Laser in situ Keratomileusis
`Richard A. Norden, MD, FACS ............................................................................................................................................... .468
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`In a prospective bilateral trial of 31 patients who underwent LASIK, brimonidine (Alphagan) was associated with
`
`
`
`
`less subconjunctival hemorrhage, less hyperemia, and no increase in LASIK flap slippage.
`
`Changes in lntraocular Pressure After Laser in situ Keratomileusis for Myopia, Hyperopia,
`
`
`
`
`
`
`
`and Astigmatism
`Luz M. Agudelo, MD; Carlos A. Molina, MD; Diego L. Alvarez, MD, MSc ............................................................................. .472
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`After LASIK, Goldmann applanation tonometry measured approximately 2 mmHg lower than preoperative.
`
`ASSl•108
`Nordan•Rr
`Trapezoid,
`
`Iatrogenic Keratectasia Following Laser in situ Keratomileusis
`
`
`
`Leopoldo Spadea, MD; Giampiero Palmieri, MD; Luigi Mosca, MD; Romina Fasciani, MD; Emilio Balestrazzi, MD ............. .475
`
`
`
`
`
`
`
`
`
`
`
`
`
`120·µm plate 1urned out histolagical/y to be approximately 260 µm thick
`A LASIK corneal flap made with a planned
`
`
`
`
`
`of •23.50 D. The excessive flap thickness and excessive ablation produced
`
`in an eye with a refractive correction
`
`
`
`
`progressive keratectasia requiring a penetrating keratoplasty.
`
`ASSl•123
`Thornton
`Corneal R
`
`Report
`Traumatic Dislocation of an Ophtec Artisan Phakic lntraocular Lens
`
`
`
`
`
`ASSl•953
`Hawke Yoon, BA; Damien C. Macaluso, MD; Majid Moshirfar, MD; Maureen Lundergan, MD ............................................. .481
`
`
`
`
`
`
`
`
`Arrowsmil
`Marker
`
`
`
`
`
`
`
`lens, the patient sustained iris-claw phakic intraocular At 5 months after successful implantation of an Ophtec Artisan
`
`
`
`blunt injury to the eye, dislocating one claw, which was successfully repositioned.
`
`Departments
`
`a ACCURATE�
`
`Todotl
`Table of Visual Acuity Equivalents ..................................................................................................... .411
`
`
`
`
`
`
`
`
`
`
`
`
`ISRS News .......................................................................................................................................... 484
`
`
`
`
`
`
`Letter to the Editor ............................................................................................................................. .486
`
`
`
`
`Radial Keratotomy Performed Over Automated Lamellar Keratectomy
`
`
`
`
`
`
`
`
`Information for Authors .................................................................................................... : ................. .487
`
`
`
`
`
`Surgery Visit the Journal of Refractive at
`
`
`
`www.slackinc.com/jrs.htm
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`
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`Op�
`
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`2002 by SLACK Incorporated. All rights
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`•
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`
`I
`
`I
`
`SLAYBACK EXHIBIT 1006
`
`Page 3 of 7
`
`

`

`
`
`
`
`Richard A. Norden, MD, FAGS
`
`E-ffect of Prophylactic Brimonidine on Bleeding
`
`
`
`After Laser in
`
`Complications and Flap Adherence
`situ Keratomileusis
`
`drop e
`Ophth
`GA),
`admin
`each i:
`15 mi1
`utes b
`by opl
`no for:
`tion. �
`monid
`cian (I
`tion. 1
`propai
`rimonidine tartrate 0.2% (Alphagan,
`
`
`ABSTRACT
`one ac
`
`
`
`Allergan, Irvine, CA), a relatj.vely selective
`PURPOSE: Several authors have assessed the
`
`dure.'
`
`
`
`
`alpha-2 adrenergic agonist, is indicated for
`
`
`effect of prophylactic briomonidine on bleeding
`thesia
`
`
`
`
`lowering intraocular pressure in patients with open­
`
`
`complications and flap adherence after laser in situ
`AftE
`
`
`keratomileusis (LASIK). This study further evalu­
`
`
`angle glaucoma or ocular hypertension. Animal
`es wei
`
`ates these potential associations.
`
`
`studies suggest that the drug is neuroprotective.
`
`METHODS: We performed a prospective, double­
`placed
`
`
`
`Although two independent clinical studies have
`
`masked, single-surgeon study of 31 patients
`violet.
`
`
`shown that topical brimonidine does not significant­
`
`
`(61 eyes) who underwent LASIK with or without
`Jacks<
`, the
`segment hemodyn amics2•
`
`
`prophylactic brimonidine for primary myopia/
`ly alter posterior
`guide
`
`
`myopic astigmatism (59 eyes) or hyperopic astig­
`
`
`
`alpha-2 adrenergic agonist drugs as a class are also
`gation
`
`matism (2 eyes). Among myopes, mean preoperative
`4 There are
`
`
`considered to be strong vasoconstrictors.
`
`sphere was -4.44 ± 2.21 D and mean cylinder was
`soluti<
`
`
`
`many anecdotal reports that the use of topical bri­
`
`-1.04 ± 1.01 D. Thirty-three eyes (54%) had nasal
`Weck
`
`monidine before laser in situ keratomileusis
`
`
`hinges; 28 eyes (46%) had superior hinges.
`intrao
`
`
`
`(LASIK) can help prevent bleeding-related problems
`
`
`RESULTS: Subconjunctival hemorrhage was
`Barra,
`
`observed in 22 of 61 eyes (36.1 %). Three of these
`
`
`
`in the anterior segment, and some refractive sur­
`ified.
`
`
`
`22 eyes (13.6%) received prophylactic brimonidine;
`
`
`geons now administer it prophylactically to reduce
`
`
`the remaining 19 eyes with subconjunctival hemor­
`ThE
`
`
`
`subconjunctival hemorrhage and improve the post­
`rhage (86.3%) did not receive brimonidine
`micro]
`
`operative appearance.
`
`(P<.0001). All but three eyes had some hyperemia;
`(Morii
`
`
`however, the amount of hyperemia was lower in the
`This prospective, double-masked trial was
`
`
`micro.
`
`
`
`brimonidine group (P<.0001). Bleeding from the
`
`
`
`
`designed to objectively assess the effect of brimoni­
`obliqu
`
`
`
`superior micropannus occurred in four of 61 eyes
`
`
`dine administration before LASIK on subconjuncti­
`
`
`(6.6%). One of these four eyes received brimonidine.
`and I
`
`
`val hemorrhage, hyperemia, and micropannus
`
`There was one case of flap slippage in a non­
`propa
`
`
`
`bleeding. Due to recent concerns about the possible
`
`brimonidine eye with a nasal hinge; no flap striae
`heads
`
`
`
`detrimental effect ofbrimonidine on flap adherence,
`
`were observed after repositioning.
`ness c
`
`
`CONCLUSION: This study suggests that brimoni­
`
`
`
`flap slippage was also evaluated in nontreated and
`elevat
`
`dine administered before LASIK may significantly
`
`treated eyes.
`
`
`reduce subconjunctival hemorrhage and reduce
`pupil,
`
`the amount of hyperemia. [J Refract Surg
`
`VISX
`
`2002;18:468-4 71]
`PATIENTS AND METHODS
`
`(Santi
`
`
`
`
`Patients with myopia, hyperopia, and/or astigma­
`""'·3.0(
`
`tism who presented to Norden Laser Eye Associates
`cycloi:
`
`
`
`for LASIK were included in this study. Patients with
`>-3.0(
`
`
`
`
`inadequate corneal thickness (pachymetry; <250 µm
`patier
`
`
`
`stromal depth after ablation), frank keratoconus, or
`both a
`
`active ocular disease were excluded, as were
`omme
`
`immunocompromised or immunosuppressed
`From Norden Laser Eye Associates, Ridgewood, NJ,
`
`molog
`
`
`
`patients. No patient had significant micropannus
`
`
`The author has no proprietary interest in the materials mentioned
`Aft,
`herein.
`
`that would contraindicate surgery.
`Correspondence: Richard A. Norden, MD, FACS, Norden Laser Eye
`
`
`
`the fl:
`
`
`
`
`Patients received ofloxacin (Ocuflox, Allergan,
`
`
`
`
`Associates, 1144 East Ridgewood Avenue, Ridgewood, NJ 07450.
`a thre
`
`
`
`
`Irvine, CA) qid 1 day before surgery. Fifteen min­
`
`Tel: 201.444.2442; Fax: 201.444.4721
`using
`
`
`Received: September 6, 2000
`
`
`
`utes before the procedure, patients received one
`
`Accepted: January 2, 2002
`
`B
`
`1
`
`3
`
`468
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`Journal
`Journal of Refractive Surgery Volume 18 July/August 2002
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`SLAYBACK EXHIBIT 1006
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`Page 4 of 7
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`Prophylactic Brlmonidine Before LASIK/Norden
`
`1
`
`n
`
`drop each of ofloxacin and diclofenac
`
`0.1 % (Voltaren
`ensured using the corneal marks. The flap was then
`
`
`
`
`Ophthalmic, CIBA Vision Ophthalmics, Atlanta,
`
`
`stroked for 15 to 20 seconds with a BSS-soaked
`GA), with a 2-minute interval between
`
`
`
`Merocel sponge to squeegee moisture from beneath
`
`
`
`
`administrations. One arbitrarily selected eye of
`
`the flap. The periphery of the flap was dried with a
`each patient
`also received one drop of brimonidine
`
`
`dry sponge to ensure a symmetric gutter. After
`
`
`
`and a second drop 5 min­15 minutes before surgery
`
`
`placing a drop of BSS over the center of the cornea,
`
`
`arbitrarily utes before surgery. Eyes were selected
`
`
`the eye was then allowed to dry for 2 minutes. After
`
`to receive brimonidine;
`
`by ophthalmic technicians
`
`
`removing the drapes and speculum, a blink test was
`
`
`
`generated the selec­no formalized random process
`
`
`performed under the operating microscope.
`
`
`
`tion. The ophthalmic te9hnicians applied the bri­
`
`
`
`All patients underwent surgery on their right eye
`
`
`
`physi­and the operating
`monidine drops. Patients
`
`
`first. During surgery of the left eye, suction ring cen­
`
`
`administra­cian (R.N.) were masked to brimonidine
`
`
`
`tration was not adjusted even when bleeding from
`
`
`one to two drops of tion. The patient also received
`
`
`the micropannus had occurred in the right eye. The
`
`
`
`room plus proparacaine upon entering the operating
`
`
`intent was to eliminate bias.
`Lagan ,
`
`
`one additional drop immediately before the proce­
`Slit-lamp microscopy was performed 5 minutes
`
`
`
`lective
`
`dure. To minimize epithelial toxicity, no other anes­
`
`
`
`postoperatively. All patients then received a copious
`ed for
`thesia was administered.
`
`
`amount of lubricating gel (Genteal, CIBA Vision
`open­
`
`
`After betadine preparation, the patient's eyelash­
`
`
`
`Ophthalmics, Atlanta, GA) to generously lubricate
`.nimal
`
`
`
`es were isolated with drapes, a lid speculum was
`
`
`the inside of the lid and the dry epithelial surface.
`ctive.
`
`placed, and the cornea was marked with gentian
`
`
`
`
`Patients then received a clear plastic shield, which
`have
`
`violet. The cornea was marked with an 8-mark
`
`remained in place until the next day. For purposes
`ficant-
`
`
`
`Jackson LASIK marker to aid flap replacement and
`
`
`of this study, eyes were examined again the next
`3, the
`
`guide alignment in the case of a free cap. After irri­
`
`
`morning. The postoperative medication regimen
`:e also
`
`
`gation of excess gentian violet with balanced salt
`
`
`consisted of ofloxacin one drop qid plus prednisolone
`,re are
`
`
`solution (BSS), the surface of the eye was dried with
`
`
`
`
`acetate 1 % (Pred Forte, Allergan, Irvine, CA) one
`al bri­
`
`
`Weck cell sponges, a suction ring was placed,
`
`drop qid for 4 days, and Refresh Plus lubricant
`leusis
`
`
`
`intraocular pressure (IOP) was verified with a
`
`(Allergan) every 2 hours for 1 week after shield
`1blems
`
`
`
`Barraquer pneumotonometer, and dilation was ver­
`removal.
`e sur­
`ified.
`The operating surgeon (R.N.) performed the post­
`
`
`
`
`:educe
`The flap was created with either the Moria LSK
`
`
`
`
`
`operative examinations and recorded the amount of
`i post-
`
`
`microkeratome, which produced a nasal hinge
`
`
`
`bleeding subconjunctival hemorrhage, hyp eremia,
`
`
`
`(Moria, Antony, France) or a Carriazo-Barraquer
`
`
`from the micropannus, and flap slippage/wrinkling .
`. was
`
`
`
`microkeratome, which produced a superior or
`
`
`Subconjunctival hemorrhage was graded according
`imoni­
`
`
`
`oblique hinge (Moria, Antony, France), and the eye
`
`
`
`to the number of involved quadrants (1 through 4);
`juncti­
`
`and microkeratome tracks were irrigated with
`
`
`(blob, the typ e of hemorrhage within the quadrant
`annus
`
`proparacaine before each pass. Microkeratome
`splinter, etc.) was not graded. Hyp eremia was grad­
`>ssible
`
`heads of 130 µm were used to achieve a flap thick­
`
`
`ed using a subjective scale that indicated severity,
`,rence,
`
`
`ness of 160 µm. After suction release, the flap was
`with O being none and 3 being the most severe.
`id and
`
`
`elevated, the laser rings were centered over the
`
`
`Superior micropannus bleeding was graded subjec­
`
`
`
`pupil, and the ablation was performed using the
`
`
`
`tively by the operating surgeon based on the amount
`
`
`VISX STAR S2 SmoothScan Excimer Laser System
`
`
`
`of bleeding (1 = trickle of short duration; 4 = profuse
`
`
`
`
`bleeding of longer duration). An independent statis­
`(Santa Clara, CA). For myopic eyes with sphere
`tigma­
`
`
`
`
`tician used various statistical sign ificance tests to
`
`
`,s;-3.00 diopters (D), 10% was subtracted from the
`>ciates
`
`
`cycloplegic refraction; for myopes with sphere
`
`
`compare the rates of subconjunctival hemorrhage,
`:s with
`
`
`
`bleed between groups. hyp eremia, and micropannus
`
`
`>-3.00 D, 15% was subtracted. For the hyp eropic
`50µm
`
`
`
`
`patient, the nomogram was adjusted according to
`1us, or
`
`
`both age and refraction, based on the published rec­
`RESULTS
`were
`
`LASIK was performed on 61 eyes of 31 patients.
`
`ommendations of Manche
`(Review of Ophthal­
`ressed
`
`
`
`
`Twenty-nine patients underwent bilateral LASIK
`Jan 1999).
`mology,
`annus
`
`
`
`and one patient underwent unilateral LASIK for
`
`
`. After placing BSS on the stromal bed, replacing
`
`
`the flap, and further irrigating under the flap with
`
`primary myopia with or without astigmatism
`ergan,
`
`
`
`(59 eyes), and one patient underwent the procedure
`
`
`
`place a three-port cannula, the flap was stroked into
`1 min­
`
`
`for primary hyperopic astigmatism (2 eyes).
`
`using a soaked Merocel sponge.
`Align ment was
`,d one
`
`11st 2002
`
`
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`
`Journal of Refractive Surgery Volume 18 July/August 2002
`
`469
`
`SLAYBACK EXHIBIT 1006
`
`Page 5 of 7
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`

`

`
`
`
`
`Prophylactic Brimonidine Before LASIK/Norden
`
`80
`
`70
`
`60
`
`50
`
`75%
`
`QNo Brimonidine (n�29)
`
`
`62% - Brimonictine (n=32)
`
`28%
`
`Thes
`istered
`conjunc
`hypere1
`help pr,
`increas
`sometir
`patient
`Ther
`betwee
`Grade of hyperemia in eyes after LASIK with and without
`
`Figure.
`
`prophylactic brimonidine.
`inciden
`the su1
`Howev1
`microkeratome; it was slightly longer for eyes that
`
`
`
`Table 2
`bleedin
`
`
`underwent flap creation with the Carriazo­
`
`
`Superior Micropannus Bleed After
`The1
`
`
`Barraquer microkeratome (average f4 seconds).
`
`LASIK With and Without Prophylactic
`ae in e:
`
`
`(Suction time was measured only for the first few
`
`Brimonidine (n=4 Eyes)
`especia
`
`
`eyes with each microkeratome; it was consistently
`Patient/ Prophylactic Subcon-Hyper-Bleeding
`sugges
`
`
`7 seconds for the Moria LSK and 14 seconds for the
`junctival emia From
`Eye Brimonidine
`review
`
`
`Carriazo-Barraquer, and because of this consistency,
`Hemorrhage Superior
`effect
`Micro-
`
`
`
`suction time was not measured for all eyes.)
`pannus
`Presen
`
`
`Thirteen (39.3%) of the Moria LSK eyes developed
`(grade) (grade) (grade)
`Refrac1
`
`
`
`subconjunctival hemorrhage, with 69% of those eyes
`3+
`3+
`0
`and R
`
`
`experiencing a severity of grade 2 or less. Similarly,
`1+
`1+
`1+
`Compl
`
`ten (35.7%) of the Carriazo-Barraquer eyes devel­
`3+
`2+
`616)fc
`
`
`oped subconjunctival hemorrhage, with 70% of
`1+
`1+
`(6 of 4/
`
`
`those eyes experiencing a severity of grade 2 or less.
`the 12'
`Preoperative refractions were available for 59 eyes.
`
`
`
`retros]
`
`Of the myopic eyes with preoperative data (57 eyes),
`Hyperemia
`Talam
`Hyperemia developed in all but three of 61 eyes
`
`
`
`
`mean preoperative sphere was -4.44 D (range -8. 75
`Increa
`
`(95.1 %) (Fisher's exact P=.2393). The three eyes
`to -0.25 D; SD ±2.21 D), and mean preoperative
`associi
`
`cylinder was -1.04 D (range -3.75 to +0.50 D; SD
`
`
`
`without hyperemia were in the brimonidine group.
`Preser
`
`
`
`
`±1.01). Preoperative spherical equivalent refrac­
`
`
`The amount of hyperemia, however, was notably
`Refrac
`
`
`lower in eyes treated prophylactically with brimoni­
`
`tions of the two hyp eropic eyes were +1.75 -0.75 D
`and I
`
`
`and +2.00 -0.75 D. Thirty-two eyes received the bri­
`
`
`
`dine (Fisher's exact P<.0001). Eighty-four percent of
`Comp]
`
`eyes had grade 1 or no hyperemia, as com­
`
`
`monidine (16 right eyes, 16 left eyes). One patient
`treated
`617)�
`pared with just 10% of the untreated
`eyes (Figure).
`
`
`
`received brimonidine in both eyes; one patient had
`monid
`
`
`surgery in only one eye, which received brimonidine.
`tions i
`
`
`Thirty-three eyes (54%) had nasal hinges; 28 eyes
`Superior Micropannus Bleed
`
`
`as jus
`
`(46%) had superior hinges.
`Bleeding from the superior micropannus occurred
`
`
`
`dine b
`
`in four of 61 eyes (6.6%). Three of these eyes did not
`Walte:
`
`
`
`
`receive brimonidine (Fisher's exact P==.3385). The
`Subconiunctival Hemorrhage
`
`in thi
`
`
`
`Subconjunctival hemorrhage was observed in
`
`for these four eyes are outlined in
`
`specific findings
`abnor
`
`22 of 61 eyes (36.1 %). Three of 22 eyes (13.6%)
`Table 2.
`pared
`
`
`
`received the prophylactic brimonidine; 19 eyes with
`with 1
`
`
`
`subconjunctival hemorrhage (86.3%) did not receive
`Flap Slippage
`There was one case of flap slippage in an eye that
`
`Tal
`
`
`
`brimonidine (Chi-square P<.0001). Table 1 shows
`Possil
`
`the amount of hemorrhage in both groups of eyes.
`
`
`did not receive brimonidine. This occurred in an eye
`
`in th
`
`with a nasal hinge (Moria LSK microkeratome). The
`There did not appear to be any correlation
`
`flap was repositioned without sequelae. No flap
`
`
`
`
`between suction time and presence or severity of
`
`
`
`
`subconjunctival hemorrhage. Suction time averaged
`
`
`striae were observed after repositioning.
`
`
`7 seconds for the corneas cut with the Moria LSK
`
`Table 1
`
`Grade of Subconjunctival Hemorrhage
`After LASIK With and Without
`Prophylactic
`
`Brimonidine (n=22 Eyes)
`% 4.0
`Grade 1 Grade 2 Grade 3 Grade 4
`Group
`(# eyes) (# eyes) (# eyes) (# eyes)
`Prophylactic
`brimonidine
`(3 of 32 eyes) 2
`
`0
`
`1
`
`0
`
`None Grade 1 Grade 2 Grade 3
`
`No brimonidine
`(19 of 29 eyes) 4
`
`9
`
`5
`
`1/0D No
`2/0S No
`3/0D No
`3/0S Yes
`
`0
`
`0
`
`470
`
`
`
`Journal of Refractive Surgery
`st 2002
`Volume 18 July/Augu
`
`Journal
`
`SLAYBACK EXHIBIT 1006
`
`Page 6 of 7
`
`

`

`-
`
`-
`
`- -
`
`- -
`
`-
`
`-
`
`-
`
`----- - -- ------ -- -- ---- --- ------.
`
`
`
`Prophylactic Brimonidine Before LASIK/Norden
`
`
`
`
`
`exposure, and increased dryness. It is possible, how­
`
`
`
`DISCUSSION
`These data demonstrate that brimonidine admin­
`
`
`ever, that flap slippage may have resulted from
`istered before LASIK can significantly reduce sub­
`
`
`
`excess moisture in the bed. After floating the flap
`
`conjunctival hemorrhage as well as the amount of
`
`
`back in place, these surgeons made just one stroke
`
`
`
`hyperemia. By preventing bleeding, the surgeon can
`
`
`with a Weck sponge, and flap slippage occurred
`
`
`
`help prevent incomplete ablation. Bleeding can also
`
`
`within 2 hours of surgery. Conversely, our flaps were
`patient anxiety, as LASIK is
`increase postoperative
`
`
`
`stroked for 15 to 20 seconds to ensure expulsion of
`
`
`
`sometimes perceived as a cosmetic procedure and
`
`
`
`excess moisture from beneath the flap.
`Walter and Gilbert
`
`
`patients prefer to look normal after surgery.
`5, on the other hand, postulat­
`
`
`There was no statistically significant correlation
`
`ed that the flap abnormalities seen in their prospec­
`
`
`
`between the use of prophylactic brimonidine and the
`tive study may have been due to brimonidine­
`j without
`
`
`incidence of micropannus bleed. Few eyes bled from
`
`
`
`induced desiccation, possible ischemia due to vaso­
`
`
`
`constriction of the anterior ocular vessels, and/or
`
`
`
`the superior micropannus, regardless of treatment.
`
`
`However, in the patient with bilateral micropannus
`
`
`
`direct toxicity. These authors intentionally per­
`es that
`
`
`formed minimal irrigation during flap replacement,
`
`
`
`bleeding, bleeding was less in the brimonidine eye.
`rriazo­
`
`and there is no mention of postoperative lubrication
`
`There was no increase in flap dislocation or stri­
`conds).
`
`
`ae in eyes treated with brimonidine. This finding is
`
`
`use. Given the anesthetic and desiccating effects of
`rst few
`
`
`especially topical in light of recent research that
`
`
`
`brimonidine, copious postoperative lubrication
`stently
`
`
`
`suggests otherwise. In his retrospective chart
`
`
`seems essential, along with ironing of the flap to
`for the
`
`
`remove fluid and minimize flap slippage .
`
`review of 174 eyes, Walter (Walter KA. Adverse
`. stency,
`
`
`effect of Alphagan on LASIK flap adherence.
`
`
`
`We routinely instill copious amounts of Genteal
`eyes.)
`
`gel into the eye to reduce friction between the upper
`
`
`
`Presented at the Symposium on Cataract, IOL, and
`reloped
`
`
`
`
`Refractive Surgery, American Society of Cataract
`
`
`lid and flap. One should be aware that the gel can
`se eyes
`
`
`insinuate itself into the lamellar interface and cause
`
`
`
`and Refractive Surgeons, Session 3-H: LASIK
`nilarly,
`
`
`inflammation, although we noted no cases of diffuse
`
`
`Complications. Boston, MA: May 22, 2000, Abstract
`devel-
`
`
`lamellar keratitis in this series.
`616)found that 13.3% of brimonidine-treated eyes
`10% of
`
`
`This study suggests that brimonidine minimizes
`
`
`(6 of 45) had early flap dislocations, whereas none of
`or less.
`
`
`
`
`subconjunctival hemorrhage without inducing flap
`
`
`the 129 control eyes had a flap dislocation. In their
`
`
`
`slippage. Given the findings of this prospective trial,
`
`
`retrospective review of 1895 consecutive cases,
`
`
`
`the efficacy of prophylactic brimonidine for reducing
`
`
`Talamo and colleagues (Talamo JH, deLuise VP.
`a eyes
`
`
`
`LASIK-related bleeding and flap complications
`
`
`
`Increased incidence of flap slippage after LASIK
`,e eyes
`
`
`deserves further study in more eyes. Other vasocon­
`
`associated with the use of preoperative Alphagan.
`group.
`
`
`strictors, such as naphazoline (Vasocon-A), may also
`
`
`
`Presented at the Symposium on Cataract, 101, and
`1otably
`
`
`
`
`produce similar results and should be studied for
`
`
`Refractive Surgery, American Society of Cataract
`:imoni­
`this application.
`
`
`
`and Refractive Surgeons, Session