34
`
`Poster Abstracts - Surgery
`
`American (Hammad Sorters 39th natural .lIrlert'r'rn,r
`
`In A Novel Technique for his Internet
`Waheculectomytnescrlptienanrocedut-earttl
`Preliminary Results
`
`ri-rontas SHUTE', Westley Green,
`James Lie. Arshern Situational
`" Washington University in St. Louis
`
`School of Medicine
`
`Furposefltalc-tranee
`iiiaumttta is the leading cause at irreversible blindness
`worldwide, affecting more than 64 milliott people. Lowering
`intraneular pressure ilGl’i remains the only was to mitigate
`the risk of glauch-tnatnus vision loss. .‘i'ledications1 LASERs.
`and incisinnal surge-t3.r aitn to lower hill“ it}: decreasing aqueous
`humor {Al-Ii pnteiucritttt ttr facilitating, its outflow.
`Thu: maitsr site of resista rice tn All rtuti‘ln‘w is thought [II
`he the ittxtacanalictllar traltecttlar naeshwurit [TML' Multiple
`trcattnent modalities steel-t tn lnwer EDP it" hypassing this tissue
`or attempting to ternut'e it altogether. These procedures {then
`require expensive implants Ilr specialized surgical ittstrutttents.
`The authors dct'eluped a technique itJr ah intertlts ttahLTttit-ctunly
`utilizing a disposable Ej'gtlllgt" hypodermic needle [or the
`treatment of open angle glaucoma. ‘l‘he sttrgieal lmreedure—
`termed heat ah irtretnu needle gonlectontt' illnNCiJ-rctnd
`preliminary results are presented here.
`
`Methods
`
`The stud}- complied with the Declaration uf Helsinki and was
`apprm-ed hr the Washingtmt Unieersity in St. Ltmis institutional
`review heard. A retrospective chart review was perforMed for all
`patients who underwent HANG ht-
`I 0F 3 :ltIIlmts at Washington
`University in St. Louis between July It] I? attd June it) its. All
`patients prtwided written consent prior to surgery. I’m-operative
`assessment included gonioseops performed by 1 old authors to
`confirm identifiable landmarks—specifically TM—and absence
`of stgnifieant nasal peripheral anterior st'nechiac. Faclt patient
`nndem'enr E-iumpl‘ttc}r 1visual field testing and retinal nerve iihcr
`layer iRNl-l] analysis using optical coherence tttmttgta phy. The
`purcmlnn: was performed alum: or in umtltiriatinn with cata tact
`surgery itt adults with ”pen angle glaucttrna.
`Tissue samples were preserved in 4% parat-tn'n'taldehtrtleiI
`phosphate htlit'erled saline hefnrt: being processed fur histology
`and etnl'iedded in pa ra flirt. Seminns were cut and stained with
`Itetnutuxt-lin-eusin and periodic acid-iichiit.
`The mean and stattdard desiatiun pre-and ptrst~operatit-e
`101’ and number of glaucoma medications were calculated. The
`student [mired t‘ test was used to oompare pre- and post-operative
`data. rI't. i" 1raltte of <0.05 was considered statistically significant.
`Surgical Procedure: The operative eye was prepped and
`draped in the usual sterile npl'I-th alrnic Fashion. a wire eyelid
`speculum was pieced. fit
`I mm pa racentcsis was created
`cithcr infctinrlt' rtr auric'riotltr1 and t'iscnelastic was used to Fill
`the anterinr chamber. ll perforated itt cnmsett with cataract
`su tger}; rhc tentptiral incision was used to gain access to the
`nasal angle. If performed as a standalone pritt-oedtltc1 :3 L4 n'ttn
`paracentesis was created temporally. The patient's head and
`
`operating Jt'tirtruscupt: were rotated to aid visualixatimt oi the
`angle structures. .Il. gttniuptisnl was. usud tu 1.‘ie'w the angle. A
`gentiotome was fashioned ht- bending the distal 1 mm oia sterile
`25~e,auge itti inch hypodermic needle toward the het'el using
`a needle driver. The heat needle was used to excise the nasal
`lflil degrees ul'l‘M. 'T'he excised portion of TM was sent For
`histologie analysis. The viscoeiastic was removed using either an
`irrigation-aspiration system or evacuated through a paraccntesis
`using balanced salt solution [355i on a cannula. l‘acl'l won nd was
`verified watertight. and the surgenn‘s preFerence nF antibiotic
`plus steroid was administered.
`If cttlnhincd with cataract surgery. tram; was perittrrnctl
`belttrc standard phactwntulsilicatinn and intrattculat lens
`implantation. Pttst-opcmtirc ca FL' and ittllttrwanp thJEL‘L'dDLl
`as with standard phacttetnulsilicatittn with intrattcttlar lens
`implantation.
`
`Results
`
`Twenty—seven eyes ni 2| patients underwent the litl. NH
`prrtced Ltrc either alum,- [twtt eye-s3 ttr ctnnhincd with
`phacttemuls'tlicatinn Elli eyes]. All patients were classified
`as ripen angle glaucoma via gttnitmttpy with stages ranging
`than mild to severe. Average pre-nperatitre mean de't'iatittn utt
`Humphrey- t-isual field testing was -T.] s: 3.1 dB. and pattern
`standard dek'latiuu was 4.2 t 2.7. Average preoperative HNI-‘L
`thickness measured lw 0LT was TEL? : l1 interim-s. Mean
`Shatter grade on gontnscopt' was 1.2 : l.3. Average ntattinttttn
`IOI’ [Tm-asl was 25.6 t 5.3: mm Hg. while mean oentral corneal
`thickness tCCT] was 550.3 : 313 microns. Mean treatment
`spanned Hilde = iii degrees of the nasal TM. Thirteen of the 21
`paticnts were female.
`Average pre—ttperatitre Iii—:11JI was 137.3 a 4.3 nirnl IS on LE
`2 1.5 topical glaucoma medications. r'tt pttst-ttperaritre nmnth
`[fills-ill tint:1 mean l'Dl' was ”.6 =14 mlnl it: if“ = fi.[l.‘ill tJl'J
`[Hi 2 LI topical glauctnna medications IF = {Lil l .1. Fit POM.
`three, mean lill’ was 14.5 : 2h rnnti’lg H" = il'Cl‘H on 1159 2
`{L39 topical glarremna medications {i’ = 0.005]. in Film sire.
`mean IOI' was is z 2.5]11fll1'lgil’2 H.031 mt LB 1 1.2. topical
`glaucoma medications IP = 0.58:.
`
`Discussion
`
`The threshold for so rgical treatment triglaucttma has been
`lowered with the adrent til Itticntirtt'asit't: glauctnna surgery
`[MlGS-J. These pren'cdures offer low risk, relatively sta t'td'artli'red+
`and highly reproducible techniques lot lowering inlraoeular
`pressure Withuul the financial harden. hazards, and compliance
`pitfalls of medications. Many at these prearedures can be
`combined with cataract surgery without increasing the risk
`alto-re standard phaeaetnttlsit‘ieatian.2 Still. the cost of MILES
`devices makes these procedures inauessihle to a large nutn her of
`patients and surgeons around the world.
`The £5:th is a asst-effective alternative to many 'T'M-hased
`glaucoma procedures. It utilires a standard hypodermic needle
`modified by the surgeon in the Fashion of a reverse csstutolnc
`to completely excise-.1 scgtncnt of TM. The hct'ei and lumen of
`the hypodermic needle cumhinc rt: htrm two cutting edges—in
`effect creating a “douhlt: blade" grtnitrtontc ca paltle of excising
`tissue en him: The dorsal portion tnc the hem ncctllc acts as a
`guard. presenting incision of the posterior wall of Schicmnt's
`canal and helping maintain the plant.- ttl excision. The width tti
`the needle's “thrLthh: hlade" is titralilitlLu-sintplzr place the head
`nearer the proximal end of the lat-rel for a wider cutting surface.
`
`Petitioner - New World Medical
`
`Ex. 1020, p. 1 of2
`
`Petitioner - New World Medical
`Ex. 1020, p. 1 of 2
`
`

`

`dirtt'rirtrri Glanctwra Society 39:}: d mural .‘ilrt'tt'rig
`
`Pastor Abatrlcts - Surgery
`
`35
`
`Similar lint-Cerium: using .1 specialized l'.IlailI.I have been iil'imrit tt}
`decrease 101‘ 26.2% over 11 Mtn'lll'lfi.'l W'l'iih: hanger follow-up
`is needed, the 101’ havering effect (if the BANG appears
`comparable at six months.
`The practice pattern at the study institution is that of a
`glaucoma relcrral center. meaning that stable patients are
`returned to their referring providers upon achievement of goal
`101’. This explains the diminishing. number of patients in the data
`collection pool orcr tintc. it also aocounts for the concentration
`over time of more refractory cases requiring topical medications
`to achieve grail IOP.
`iixistingTM-hasul MICE implants; and surgical instruments
`can he earpcmtivc. Many practices, esfitinllf in the developing
`world, do rtttt have the ahility ttt tifientl l'ttlnd I'L‘dii tnr US dollars
`an a single-Lise instnn'nent with mildntn—mufierate 101’ lowering
`ellect. Many financially Sta l'lll.‘ practice: would welcome the
`opportunity to lower a glauctmta patiettt‘s medication harden via
`a met-eflemiire, low risk. arid implant-[rec MIGS puree-dare. Ft
`recent Interact aearelt showed that a lilU-muut box of 2.51auge
`Sifl inelt itetdlescosts approximately I I US dollars. Additionally,
`most operating venues already have 25~gauge hypodermic
`needles at their disposal. making this proeodure readily available
`to the angle surgeon. in an era when 1'1.le deriees can he made
`unavailable to the population at a moment's notice. haying
`severai viable options For safe IOI’ lowering is paramount.
`
`Conclusion
`
`The HANG I'Jl'll'L'ljtll't.‘ repreiientr. an accessible THUG}; ttptinn,
`1with preliminary trulrtnncts similar to thus: of much more
`expensive alternatives. While the earl y results are promising, a
`prospective study is underway to further chantcteri-a: the long-
`term outcomes oi this novel technique.
`
`2.
`
`Intervention
`I. Grant WM. (ilirtical measurements of aqueous oulFlnw. rill-LII. their
`Oplrtfiraimuf 195 Irlfllltl ] 3—13 l.
`fialnuelson TW. Kat: L_l. Wellst'i-L et al. Randontitod evaluation
`Ill the Iralwcular Inicm-llypars stem With phatwlhulsilicatiml
`in patients. withelanmma and cataract. Unirtlmlmoiogy.
`ZDI l :ll3[33:4$9-61
`llnrairai 5K. Seihold [.K, Radciiffe NM. ct al. lI-Month Outcomes
`ul Ulrniututny Performed Usirn; the Kahmk Hual Blade Ctrmhint'tl
`with Cataract Singer}- in lit-ca with Medically Treated {Elanmmm
`illrl'tr 'Hm'. 21.113 SepLi.5l5'i:146Ll-I4Ei9.
`
`.3.
`
`Petitioner - New World Medical
`
`Ex. 1020, p. 2 of2
`
`Petitioner - New World Medical
`Ex. 1020, p. 2 of 2
`
`