Documenta Ophthalmologica Proceedings Series 43
`
`Second European Glaucoma Symposium
`
`Helsinki, May 1984
`
`Edited by E.L. Greve, W. Leydhecker
`
`and C. Raitta
`
`Dr W. Junk publishers
`
`Petitioner - New World Medical
`Ex. 1004, p. 1 of 9
`
`

`

`Distributors
`
`for the United States and Canada: Kluwer Academic Publishers, 190 Old Derby
`Street, Hingham, MA 02043, USA
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`Falcon House, Queen Square, Lancaster LAI lRN, UK
`for all other countries: Kluwer Academic Publishers Group, Distribution Center,
`P.O. Box 322, 3300 AH Dordrecht, The Netherlands
`
`Library of Congress Cataloging in Publication Data
`
`European Glaucoma Symposium (2nd: 1984 : Helsinki,
`Finland)
`Second European Glaucoma Symposium, Helsinki, M~
`1984.
`
`(Document a ophthalmologica. Proceedings series ;
`v. 43)
`Includes index.
`1. Claucoma--Congresses. 2. Perimetry--Congresses.
`I. Greve, Erik L.
`II. Leydhecker, W. (Wolfgang)
`III. Raitta, C.
`IV. Title. V. Series.
`[DNLM:
`1. Glaucoma--congresses. 2. Glaucoma--therapy--con(cid:173)
`gresses. W3 D0637 v.43 I WW 290 E887 1984sJ
`
`RE871.E97 1984
`
`617.7'41
`
`85-4287
`
`ISBN-13: 978-94-010-8934-0
`DOI:I0.I007/978-94-009-5516-5
`
`e-ISBN-13: 978-94-009-5516-5
`
`Copyright
`
`© 1985 by Dr W. Junk Publishers, Dordrecht.
`
`Softcover reprint of the hardcover 1 st edition 1985
`
`All rights reserved. No part of this publication may be reproduced, stored in a
`retrieval system, or transmitted in any form or by any means, mechanical,
`photocopying, recording, or otherwise, without the prior written permission of
`the publishers,
`Dr W. Junk Publishers, P.O. Box 163, 3300 AD Dordrecht, The Netherlands
`
`Petitioner - New World Medical
`Ex. 1004, p. 2 of 9
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`

`

`GONIOSCOPIC TRABECULOTOMY. FIRST RESULTS
`
`MANUEL QUINTANA
`(Barcelona, Spain)
`
`ABSTRACT
`
`We describe a surgical method of goniotrabeculotomy which achieves a
`section of the trabecular meshwork without damage to the external wall of
`Schlemm's canal. Complications are minimal. A one year follow-up shows a
`fall of intraocular pressure in almost all cases. However, this effect is non(cid:173)
`lasting and a slow rise in pressure occurs in most cases. Yet, medical therapy,
`if reinstituted, achieves a better control than before the operation and usually
`can be less intense.
`
`INTRODUCTION
`
`Increased resistance to the outflow of aqueous through the trabecular mesh(cid:173)
`work is the most accepted pathogenic mechanism in the majority of open(cid:173)
`angle glaucomas ("trabecular glaucomas"). Thus, the rational treatment of
`the trabecular glaucomas should consist in opening the trabecular meshwork
`(TM). This has been attempted since the last century (11, 12; 13) and many
`times later on (1,2,4,5,8,9), but all the techniques described so far have
`failed (3, 10) despite the in vitro evidence (6, 7) of the effectiveness of
`trabeculotomy.
`
`MATERIAL AND METHODS
`
`A technique of trabeculotomy has been devised, which eliminates most of the
`presumed causes of failure of previous methods. The patient is operated
`under general anaesthesia; both eyes can be done at the same time. Pupils
`should be miotic. A coaxial operating microscope is necessary, with magni(cid:173)
`fication of x 10. We favour the Swann lens for angle visualisation. Our
`trabeculotome is a 0.4 x 15 mm needle, or an insuline-type needle; we bend
`the tip 20-30° with a needle-holder; a factory-made needle (Morie, France) is
`even better. The needle is inserted into a syringe filled with "healon".
`"Modus operandi" is as in classical goniotomy (surgeon in the temporal side
`of the patient, patient's head rotated away from the surgeon, assistant holding
`
`E.L. Greve, W. Leydhecker& C. Raitta (eds.), Second European Glaucoma Symposium, Helsinki 1984.
`© 1985, Dr. W. Junk Publishers, Dordrecht. ISBN 978-94-010-8934-0
`
`265
`
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`Ex. 1004, p. 3 of 9
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`

`

`Fig. 1. Schematic drawing comparing the tangential approach to the perpendicular
`approach as in classic goniotomy or goniotrabeculotomy.
`
`the vertical recti). The needle penetrates the anterior chamber at 6 hours
`(right eye) or 12 hours (left eye) through the scleral side of the limbus; this is
`in order to run parallel to Schlemm's canal. Penetration at 6 or 12 hours
`allows a tangential approach (Fig. 1) to the angle; this avoids the pupillary
`field and the convexity of the lens. Penetration is carried on under direct
`control, to avoid the prismatic effect of the goniolens. Once the needle is in
`the anterior chamber, the goniolens is inserted, held with the surgeon's left
`hand. A drop of "healon" is a good wetting agent between cornea and gonio(cid:173)
`lens. The TM is incised with the tip of the needle. From now on, and with the
`concavity of the tip towards the surgeon, the trabeculotome is progressively
`introduced in the angle. Only the tip of the instrument is introduced into
`Schlemm's canal, and the TM is stripped slowly, gently and easily from the
`canal's lumen towards the anterior chamber as the needle progresses in the
`angle (Fig. 2). Since the convexity of the tip is facing the external wall of the
`canal, this structure is not damaged. This is why we bend the tip and we point
`it towards the anterior chamber.
`As in goniotomy, the assistant will rotate the globe clockwise as the
`surgeon
`introduces the
`trabeculotome counter-clockwise. A 100-120°
`trabeculotomy can be achieved. Healon can be injected at will at any time if
`the surgeon wants to deepen the angle. There is usually no chamber loss, but
`if this is the case, healon is injected.
`Once trabeculotomy is completed, the trabeculotome is withdrawn, taking
`care of injecting some healon before leaving the anterior chamber (internal
`"tamponnade"); this avoids any loss of aqueous and the chamber remains
`full. The goniolens and rectus forceps are also withdrawn. A steroid-antibiotic
`ointment is applied, as well as a mild mydriatic. The eyes are patched for 24
`hours.
`
`266
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`Ex. 1004, p. 4 of 9
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`

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`Fig. 2. Goniophotography at operation. The tip of the needle stripping the trabecular
`meshwork.
`
`Twenty-one eyes of 12 patients have been operated with this technique,
`with a follow-up period of one year (mean). There are 13 eyes with chronic
`open-angle glaucoma, 3 with pigmentary glaucoma, 4 disgenetic and 1 steroid(cid:173)
`induced. Details are summarized in Table 1.
`
`RESULTS
`
`Complications
`
`There are no operative complications, not even hyphema, provided there is no
`chamber loss ("ex vacuum" hyphema).
`Postoperative complications are hypherma, moderate, in 6 cases; and
`atropy of the iris in three cases. Iris atrophy does not occur since we give
`steroids and we dilate the pupils (see discussion).
`
`Clinical results
`
`The behaviour of the ocular pressures over one year is represented in Table 1
`and Fig. 3. They can be summarized as follows: fall of pressure below 20 mm
`Hg in almost all cases in the first postoperative weeks, followed by a progress(cid:173)
`ive rise in the second month (mean). From the second month, medical
`therapy must be reinstituted in most cases, although less intensively in
`regard to the preoperative treatment. At one year, most cases are controlled,
`
`267
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`Ex. 1004, p. 5 of 9
`
`

`

`18 P-T
`
`22 -
`24 -
`
`19 P-T
`
`18 P-T
`20 T
`20 -
`19 T-A 250
`18 T-A 250
`20 T-A 125
`21 T-A 125
`16 T
`19 T
`lost
`lost
`17 P-T
`10 -
`17 T-A 125
`15 T-A 125
`13T
`15 P-T
`
`Po 1 Year
`
`18 P-T
`
`20 -
`24 -
`
`34 -
`
`30 -
`30 -
`23 -
`48 -
`38 -
`23 -
`28 -
`25 -
`22 -
`27 -
`26 -
`34 -
`14 -
`23 -:
`24 -
`23 -
`30 -
`
`Po 2 Months
`
`hyphema +
`
`Iris a trophy
`Iris a trophy
`hyphema +
`hyphema +
`hyphema + +
`
`Iris atropy
`
`hyphema +
`Complications
`
`Upper half of each patient: right eye; lower half: left eye
`Dash (-) after Po figures indicates no treatment.
`
`30 -
`
`14 -
`14 -
`
`10 -
`
`18 -
`18 -
`14 -
`28 -
`19 -
`18 -
`16 -
`19 -
`6-
`38 -
`18 -
`14 -
`14 -
`17 -
`15 -
`18 -
`17 -
`
`14
`38 P-T
`
`20 P-T
`20 P-T
`
`NOOP.
`
`24 -
`46 -
`24 P-T NOOP.
`32 P-T
`39 P-T-A 500
`21 P-T-A 500
`40 T-A 500
`45 T-A 500
`30 P-T-A 500
`30 P-T-A 500
`23 T-A-250
`25 T-A 250
`30 P-T-A 375
`34 P-T-A 375
`30 P-T
`21 P-T
`20 P-T-A 750
`20 P-T-A 750
`40 P-T-A 750
`40 P-T-A 750
`
`pigmentary
`
`(R.E.)
`cortisonic
`disgenetic
`
`+
`
`C.O.A.G.
`
`pigmentary
`
`C.O.A.G.
`
`C.O.A.G
`
`C.O.A.G.
`
`disgenetic
`
`C.O.A.G.
`
`disgenetic
`
`C.O.A.G.
`
`C.O.A.G.
`
`16
`
`45
`
`13
`
`41
`
`62
`
`76
`
`80
`
`24
`
`66
`
`61
`
`75
`
`60
`
`Mr.C.
`
`Mr. V.
`
`Miss O.
`
`Mrs.N.
`
`Mr. V.
`
`Mr. C.
`
`Mrs. s.
`
`Mr. V.
`
`Mr.B.
`
`Mr.Z.
`
`Mr.N.
`
`Mrs. C.
`
`Po 15 d.
`
`Po Preop./mmHg
`
`Glaucoma
`
`Age
`
`Patient
`
`2/day: A'= acetazolamide, number after A indicates mgrs. per day; COAG '= chronic open angle glaucoma).
`Table 1. Patient data: age, sex, type of glaucoma, ocular pressures, complications and treatment (P '= pilocarpine 2% 3/day: T'= timolol 0.50%
`
`00
`0\
`N
`
`Petitioner - New World Medical
`Ex. 1004, p. 6 of 9
`
`

`

`ment; T = treatment -indicated in Table 1).
`Fig. 3. Graphic showing the behaviour of ocular pressures in the one year period. (MTT = maximum tolerated medical treatment; no T = no treat(cid:173)
`1.y
`
`f5"
`
`DAYS
`
`~~ ~O.'>
`
`~o
`
`O~I ____________ ~ ____ ~ __________________ ~ __________________ ~ ________________ ~
`
`- ---
`
`---
`
`--(cid:173)
`
`'----
`
`"
`
`iO
`
`l.O~
`
`\0
`0"(cid:173)
`N
`
`\
`
`\
`
`,
`
`"
`
`"" .............
`
`....
`
`\
`
`\
`
`\
`
`\
`,,'\
`
`'"
`
`""
`
`,
`
`,
`
`T
`
`NO T/2T/
`
`NO T /2T/
`
`-lMTT
`
`'0
`
`"" "c.
`
`,/
`
`""
`
`""
`
`""
`
`,
`
`,-
`
`,-
`
`""
`30-r .. · .. '~', \ ~
`,
`
`~O-1.. .~~
`
`\
`
`1
`
`~O
`
`.II ~"r _ •• ~-..
`
`. ,
`
`.,
`
`\
`
`\
`
`,
`
`.....
`"-
`
`.......
`
`,,"
`
`JI
`
`/ ~~ \
`
`Petitioner - New World Medical
`Ex. 1004, p. 7 of 9
`
`

`

`but very few without treatment. Treatment is always weaker than preoperat(cid:173)
`ively.
`
`DISCUSSION
`
`The fall of pressure was predictable and is a clinical proof of the pathogenic
`mechanism of the TM in open-angle glaucomas. The rise in pressure after
`a few months indicates that there is some kind of repair in the surgically
`damaged area. Yet, the trabecular meshwork cells are known not to repro(cid:173)
`duce; moreover, with this technique the scleral wall of Schlemm's canal is
`not damaged. But the remaining cells can enlarge, as do the corneal endo(cid:173)
`thelial cells, and this is the subject of our present research; complete repair
`does not seem to take place in the majority of cases, since in almost all of
`them the medical control is better than before the operation.
`Hyphema is attributed to reflux from the open Schlemm's canal and is
`always transient.
`Iritis with secondary atrophy, similar to the "Urrets syndrome" described
`after some cases of keratoplasty, is attributed to the liberation of pros(cid:173)
`taglandins by the damaged trabecular cells. Avoiding postoperative miosis
`(since the angle is open) and therapy with topical steroids and antiprostag(cid:173)
`landins systemically or topically avoids iritis; this complication occurred in
`some of our first cases, but no more after we instituted the above-mentioned
`postoperative care.
`In conclusion, our results show that goniotrabeculotomy, although highly
`successful in the first postoperative month, is in the end a partially successful
`procedure. Further studies are necessary to disclose the "in vivo" behaviour
`of the sectioned trabecular meshwork.
`
`REFERENCES
`
`1. Barkan, O. A new operation for chronic glaucoma. Restoration of physiological
`function by opening Schlemm's canal under direct magnification. Am. J. Opthalmol.
`19:951-966,1936.
`2. Barkan, O. Microsurgery in chronic simple glaucoma. Arch. Ophthalmol. 21 :403-
`405,1938.
`3. Becker, B., Podos, S. and Assef, C.F. Microsurgery of the outflow channels. Clinical
`research. Trans. Am. Acad. Ophthalmol. Otol. 76:405-410, 1972.
`4. Bietti, G.B., Quaranta, C.A. Considerazioni sulla terapia di particolari forme di
`"glaucoma cortisone" con speziali riguardi a quella chirurgia mediane goniotomia.
`Documenta Ophthal. 20:257-271, 1966.
`5. Bietti, G.B., Quaranta, C.A. Indications for and results of iridocorneal angle incision
`(goniotomy, goniotrabeculotomy or trabeculotomy). Trans. ophthalmol. Soc. N.Z.
`20:20-42,1968.
`6. Grant, W.M. Microsurgery of the outflow channels. Laboratory research. Trans.
`Am. Acad. Ophthalmol. Otol. 76:398-404, 1972.
`7. Johnstone, M.A., Grant, W.M. Microsurgery of Schlemm's car>al and the human
`aquaeous outflow system. Am. J. Ophthalmol. 76 :906-917, 1973.
`8. Quintana, M. Variantes en microcirugia del glaucoma. Arch. Soc. Esp. Oftal. 33:
`929-932,1973.
`
`270
`
`Petitioner - New World Medical
`Ex. 1004, p. 8 of 9
`
`

`

`9. Quintana, M. Trabecu10tomiaabinterno. Arch. Soc. Esp. Oftal. 37:193-200, 1977.
`10. Spencer, W.H. Histological evaluation of microsurgical glaucoma techniques. Trans.
`Am. Acad. Ophthalmol. Oto!. 76:389-397,1972.
`11. Tailor, U. Sulla incisione del'angolo irideo (contributo a la cura del glaucoma).
`Ann. Ottal. e Clin. Oculistica 20:117-127, 1891.
`12. Vincentiis, C. and Tailor, U. Incisione del'angolo irideo nel glaucoma. Ann. Otta!. e
`Clin. Oculistica 22:540-542, 1983.
`13. de Wecker, L. La sc1erotomie interne. Ann. D'Oculistique 113:95-109,1985.
`
`Author's address:
`Departament d'Oftalmologia
`Hospital de Bellvitge
`"Princeps d 'Espanya"
`C/o Feixa Llarga, SIN
`Barcelona
`Spain
`
`271
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`Ex. 1004, p. 9 of 9
`
`