TRANSACTlONS
`
`AMERKMLIACADEMY
`
`fl
`
`OPHTHALMOLOGY
`
`and
`
`OTOLARYNGOLOGY
`
`SECTION ON OPHTHALMOLOGY
`
`VOLUME 79
`
`NUMBER 1
`
`JANUARY - FEBRUARY
`
`1975
`
`Copyright © l975 hy the American Academy
`of Ophthalmology and Otolaryngology
`
`All material subject to this copyright may be photocopied for the
`noncommercial purpose of scientific and educational advancement.
`
`PRINTED IN U.S,A.
`
`APOTEX1014,pg.1
`
`APOTEX 1014, pg. 1
`
`

`

`TRAN§A€GTEON§
`
`American Aoademy of @phthnlmology and @tolaryngoiogy
`
`
`VOLUME 79
`
`IAN'UARY — FEBRUARY 1975
`
`NUMBER 1
`
`EDITORIAL BOARD
`
`W. Howard Morrison, Omaha, Edi!07’-’l7lv*C]1I.€7L
`
`Clair M. Kos, lowa City, Business Jrl'cmager
`
`D. Thane R. Cody, Rochester, Minn, Associate Editor for Otolargvngology
`
`Stanley M. Truhlsen, Omaha, Associate Editor for Ophthalmology
`
`Board of Secretaries: Frederick C. Rlodi, Eugene L. Derlaclci, Brian F. McCabe,
`
`George F, Reed, David Shoch, Bruce E. Spivey
`
` 3115iness and Editorial Oliices
`
`American Academy of Ophthalmology and Otolaryngology
`
`15 Second St SW, Rochester, Minn
`
`55901
`
`APOTEX 1014, pg. 2
`
`APOTEX 1014, pg. 2
`
`

`

`This material may be protected by Copyright law (Title 17 U.S. Code)
`
`THE PUNCTUM PLUG:
`EVALUATION OF A NEW TREATMENT FOR THE DRY EYE
`
`JICRRE MINOR FREEMAN, M D
`MEMPnis, TENNESSEE
`
`KERA'rITIs sicca, or keratoconjunctivi—
`tis sicca,
`is a problem in almost every
`ophthalmologist’s practice. Various types
`of
`topical drops and ointments have
`been and are being used with various
`rates of success. Occasionally, closure
`of the puncta and canaliculi by surgery
`or cauterization has been done with sue
`eess
`in more extreme cases,
`such as
`
`Sjogren’s syndromefls2
`
`a method of
`This paper describes
`closing the punctum and canaliculus by
`a plug which can be removed if un--
`desirable results occur. Jones et al3 in
`1972 devised a
`tapered polyethylene
`tube or cone to temporarily occlude ei—
`ther the upper or lower punctum and
`canaliculus, while they measured the
`relative
`speed
`of
`lacrimal
`excretion
`through the opposite canaliculus.
`
`The anatomy involved is the slightly
`elevated punctum openings in both up—
`per and lower lids about 6 mm from
`the medial canthus. These are round
`or slightly ovoid openings approximate—
`ly 0.3 mm in size. This. opening is sur—
`rounded by a fairly dense,
`relatively
`avascular
`connective
`ring of
`tissue
`about
`1 mm in depth. This leads into
`the vertical portion of the canaliculus.
`which is about 2.5 to 3.5 mm in length,
`before turning horizontally for 8 min
`to join the other canaliculus before en—
`tering the lacrimal sac. The canaliculi
`are about 0.5 mm in diameter, lined by
`
`
`
`l’rom the University of Tennessee lrIethodist Hospi-
`tal, Memphis.
`Presented at
`the Seventy-ninth Annual Bleeting of the
`American Academy of Ophthalmology and Otolaryll—
`gology, Dallas, Oct 6-10, 1974.
`
`epithelium .c‘ 1r—
`squamous
`stratified
`rounded by elastic tissue, allowing the
`canaliculi
`to be easily dilated to three
`times normal sized“!5
`
`Although some authors“ have rug—
`gested that the punctum has a sphincter
`ring of muscle, L. T. Jones, MD (per—
`sonal communication, 1974), believes
`that practically speaking there is no
`muscle sphincter, but that
`the w; 1'; of
`the punctum is much like that of
`the
`canaliculi, consisting of
`a fibroetastic
`band of
`tissue. This band or ii
`of
`
`connective tissue is
`the structure that
`
`is dilated with great care and gentle—
`ness, as described later in this “port.
`
`M ETH ODS AND 1V1 ATERTALS
`
`The punctum plug, or the device to
`close the punctum,
`is designed t2- conr
`pletely
`close
`the
`punctum opening.
`It has a slightly larger portion pro-
`
`jecting into the vertical port'm of
`the canaliculus that prevents the plug
`from extruding or coming out, and 21
`larger, smooth head at the operfiag that
`prevents the plug from passing down
`into the canaliculus. The heat
`is 3P'
`proximately 1.5 to 2 mm in diameter
`
`and 07 mm high. Having the head
`smooth and dome—shaped allow it.
`to
`rest
`in the lacrimal
`lake and 21g§111§t
`conjunctiva and cornea with Lyle 1“?
`tation. The neck or waist
`is approx?
`inately 0.7 mm in diameter and 1.5 mm
`in length. This connects to t“: large?
`tip. or barb, which is
`1 mm long and
`1.2 to 1.9 min in diameter, casing to a
`flat point 0.5 ’mm across.
`
`013—874
`
`APOTEX 1014, pg. 3
`
`
`
`APOTEX 1014, pg. 3
`
`

`

`VOLUME 71,)... .
`Nov-DEC [
`“
`
`PUNCTUM Pl.UG
`
`0137875
`
`1\,/[3terials considered for this device
`were silicon, Teflon, methyl methacrylate,
`11yd1'0K;‘ - thylmethacrylate
`(H E M A) ,
`and inert metals. Two materials were
`initially selected for
`their availability
`and waved
`high
`tissue
`tolerance:
`HEMA and Teflon.
`
`HER/IA showed excellent patient and
`tissue asseptance.
`In the dry state its
`firmness helped to ease the process of
`insertion, and it became almost
`imme4
`diately soft and flexible as tears or drops
`moistened
`it.
`Its
`approximate
`28%
`swell
`i ale when moistened undoubted—
`lv helped close the punctum more eff
`fectively. The tensile strength of HEMA
`is a drawback,
`in that manipulation by
`a patient’s
`finger
`can contribute
`to
`breakage.
`
`Teflcn also has excellent tissue toler—
`
`ance, and it has had good patient ace
`ceptance after the design was perfected.
`The material strength is excellent. Both
`HEM/t and Teflon are easily sterilized.
`
`Technique of insertion is as follows.
`The eye is anesthetized with a topical
`anesthetic. A shortened cotton~tipped
`applicator is soaked in the same topical
`anesthetic and placed into the medial
`canthai area for
`five to ten minutes.
`
`is carefully
`Then a punctum dilator
`used to slowly dilate the punctum to
`about
`1.2 mm without breaking the
`punctum connective tissue ring. Break—
`ing this ring or splitting the punctum
`encourages a loose or sloppy fit and sub
`sequent extrusion or loss of the plug.
`
`removing the dilator,
`Quickly after
`the pmctum plug, held in an inserter in
`the form of a rod,
`is placed into the
`punctum opening. The punctum plug
`tip is pointed to encourage some dila—
`tion and passage into the canaliculus.
`As soon as the head is seated at
`the
`punctum opening, a shearing or wob—
`bling; motion disengages
`the inserted
`punctum plug.
`
`For removal, the head of the plug or
`the neck just under the head is grasped
`iwith forceps. If topical anesthetics do
`not relieve discomfort enough here, lido—
`caine hydrochloride or similar anesthetic
`can be injected directly into the medial
`lid area. This may be highly desirable,
`because the horizontal canalicular area
`
`can then be squeezed gently with smooth
`forceps, and with movement toward the
`plug,
`the punctum plug can literally be
`squeezed or expressed out.
`
`The patients treated were usually suf—
`fering from symptomatic keratoconjunc—
`tivitis sicca, confirmed by positive rose
`bengal stain. The symptomatically drier
`eye was selected and a punctum plug
`was inserted into the lower punctum of
`that eye. There were two or three pa—
`tients who had early extrusion before
`the design previously described was se
`lected.
`
`RESULTS
`
`seven patients had a
`A group of
`HEMA punctum plug placed into one
`lower punctum. Although there was var—
`iation of expression of comfort, all pa—
`tients accepted the plug and expressed
`that the involved eye became more com—
`fortable than the fellow eye. Some pa—
`tients could feel the plug at times, espe—
`cially when the
`cornea was
`turned
`toward the punctum plug. but there was
`no discomfort. One plug had broken at
`approximately one week, and the rest
`of
`the plug was expressed from the
`canaliculus. Another plug,
`that appar-
`ently did not seat well from the begin~
`ning and projected from the punctum,
`showed some mild surrounding conjunc—
`tival injection, probably from excessive
`movement of the plug. This plug was
`removed at six weeks, although the pa
`tient had expressed no complaints. Af~
`ter removal,
`the patient stated her in—
`volved eye felt worse for about
`five
`days, but it symptomatically became sim-
`
`APOTEX 1014, pg. 4
`
`APOTEX 1014, pg. 4
`
`

`

`
`
`0137876
`
`
`
`JERRE MINOR FREEMAN
`
`
`
`TR AM AA"OPHTH 8: OI‘OL
`
`ilar to her fellow dry eye, thus showing
`the reversible facet of
`this treatment
`
`both in the ability to remove the punc—
`tum plug if desired and in the treated
`eye showing comfort,
`then discomfort
`upon removal.
`
`inade
`Four HEMA plugs came out
`vertently, probably during sleep. Two
`occurred at approximately six weeks,
`the other two at 13 and 16 weeks. All
`
`patients reported a return of their dry
`eye discomfort after loss of their plug.
`The one remaining patient
`is still
`tole
`erating the plttg as of this date and con—
`tinues to report improvement
`in symp—
`toms.
`
`A second group of 12 patients had
`insertion of a Teflon plug of similar
`design as the first HHMA plug. Un—
`like the HEMA plug, where there is ale
`most 100% comfort,
`the initial Teflon
`plug was reported to be irritating by
`25% of the patients in this group. Ob—
`jectively,
`in two patients there was mild
`fluorescein staining on the cornea, where
`the cornea touched the plug head on
`rotating
`nasally. Without
`IIEMA’s
`flexibility,
`the same head design in the
`firmer Teflon was symptomatic to these
`patients. Of the 12 patients, three were
`removed within nine days and two were
`removed within nine weeks due to dis—
`
`comfort. One patient had the plug ex—
`trude or fall out. The remaining seven
`patients are doing well.
`
`The third group of patients had a
`redesigned, smaller Teflon plug insert—
`ed. The main changes were a smaller
`( 0.5 mm diameter) dome~shaped head
`and a smaller diameter (1.2 mm) barb.
`These plugs were initially better
`re—
`ceived, with comfort being acceptable
`by all patients and objectively there be
`ing no staining of
`the conjunctiva or
`cornea.
`
`Of the 13 patients in group 3, four
`had had their plugs inadvertently wiped
`
`out or plugs fell out between one and
`three weeks. All four of these patie 115
`had had a larger Teflon or IIEMA plugr
`inserted previously,
`and possibly
`be
`punctum was still dilated from this, en—
`couraging a looser
`fit and subsequent
`loss. The remaining nine patients re»
`ported increased or acceptable comfort
`of
`the dry eye and are doing wel. as
`of this date.
`
`Of interest is that three patients were
`in all
`three groups. They then were
`able to compare a treated eye with a
`nontreated eye and to compare the com—
`fort of the three different plugs.
`'7 ‘hey
`reported increased comfort of the treat—
`ed eye over that of the untreated eye.
`The IIEMA plug and the smaller Teflon
`plug were reported as the more com—
`fortable designs.
`
`Four patients after having one ” unc—
`tum plug inserted with comfort, request-
`ed the insertion of a punctum prug in
`the fellow eye. One punctum plug was
`placed in one upper punctum, but came
`out overnight mainly due to a loeie fit.
`All work in this report was done with
`the lower punctum. Tl’iirtyetwe eyes
`were treated in this study. Twenty—six
`patients were female and six patients
`were male. Average age was 54 years.
`
`this
`the work reported 7's
`Most of
`paper was carried out during the spring,
`summer, and fall in the 1nid—Sm:"'i are?!
`when heating was not necessary.
`31‘
`lowing the sufferers of keratoconjunc—
`tivitis sicca to generally do their bCSt-
`It
`is entirely possible that
`the lower
`humidity and dry heat experienc’i dUT‘
`ing the winter would have shown an
`even greater patient symptomatic differ-
`ence between the treated eye "“1d the
`nontreated eye.
`
`CONCLUSIONS
`
`s
`.
`.
`4
`.
`.
`.
`.
`In every case except where tl‘ It Wa
`Initial discomfort,
`the punctum ping-
`APOTEX 1014, pg. 5
`
`APOTEX 1014, pg. 5
`
`

`

`voi qu. 7‘)
`M)».
`in: 1‘775
`
`PL'NCTUM PLUG
`
`0137877
`
`tole‘ated by all patients with im—
`we
`provement
`in symptoms in the treated
`eye Objective tests
`for
`improvement
`were not done in this work. There were
`no instances of infection, although dis—
`comfort required removal of
`the plug
`in six instances. One plug head had
`bro en, requiring removal of the plug.
`All successful patients reported a de-
`crease in the need for drops or oints
`men
`Fpiphora occasionally occurred
`in some patients but was a transient
`proi Lem. Early morning mucous strands
`or “matter” was a problem in a few in—
`starnes. Usually these same patients
`statrd they frequently had mucus strings
`before insertion of
`a punctum plug.
`Thee same patients were cautioned not
`to accidentally wipe
`their plug out.
`Overall success rate was 50% to 75%.
`“Jul selection of patients, use of
`the
`more refined design, and avoidance of
`oveiifllating, clinical experience should
`exceed 75% success rate.
`
`improved visual
`Other than comfort,
`acuity might be a benefit experienced by
`some patients. Although visual acuity
`was not measured as a parameter in
`this work, 3 of the 32 eyes showed an
`improvement
`in acuity of at
`least one
`line.
`
`\i’liriial acuity is dependent upon the
`optically smooth precorneal
`tear
`film.
`Any :ondition such as a dry eye that
`compromises
`this
`film contributes
`to
`
`poorer acuity. Any therapy that pro—
`moter
`the. preservation, stability, and in—
`tegrity of this tear film should, inturn,
`Ililpl‘iy'xf‘. visual acuity.
`
`DISCUSSION
`
`antibiotic
`possibly
`syndrome,
`gren's
`drops in low dosage should be used.
`
`The primary indication for this then
`apy is the clinical dry eye, although it
`was used in two eyes with mild Sjo—
`gren’s syndrome. Other possible indie
`cations include the longtime contact lens
`wearer with developing dry eye; pre-
`serving tears here may allow the patient
`to wear his contact lenses with comfort
`and to experience better vision for many
`years longer.
`
`In glaucoma therapy with echothiow
`phate iodide or other therapy, the punc~
`tum plug could help prevent systemic
`absorption of the drug, thus enhancing
`therapeutic safety. In continuous 24~hour
`lavage after chemical injury or for cor~
`neal ulcers,
`the punctum plug could
`prevent fluid and medication from en—
`tering the nose and subsequent systemic
`absorption.
`
`By effectively plugging the punctum,
`the plug encourages longer contact of
`topical medications with the eye;
`thus,
`increased ocular absorption may occur
`with increased efficacy of any drug.
`
`The success rate of this mode of ther-
`
`apy probably will depend in part upon
`similar factors controlling contact
`lens
`success. If the patient has sufficient re—
`ward (such as a more comfortable moist
`eye)
`for tolerating the plug,
`then suc—
`cess will be high.
`if the plug causes
`discomfort to exceed the comfort gained,
`then there is no reason to tolerate the
`
`include plug de—
`factors
`plug. Other
`sign and material acceptance, but, hopes
`fully,
`this has evolved to a manage—
`able stage.
`
`The punctum plug probably acts to
`preserve all
`three layers of
`the tear
`film:
`the mucin,
`the aqueous, and the
`llpid components. No doubt,
`lysozyme
`helps to prevent infection in the simple
`lieratitis sicca eye. If the plug is used
`In ly: ,zzyme deficient eyes such as Sjo—
`
`After the plug head broke in the pa—
`tient
`in group 1,
`the remainder of the
`plug remained quite stationary and did
`not move down the canalieulae. The
`barb. once seated, no doubt,
`is held
`tightly by the elastictissue of the canalic—
`uli and resists movement
`in either di—
`
`APOTEX 1014, pg. 6
`
`APOTEX 1014, pg. 6
`
`

`

`OP—878
`
`
`JERRE MINOR FREEMAN
`
`TR A1\I ACAD
`oPHrH & ()TO]
`
`rection. This is highly desirable because
`the complication of a foreign body pass»
`ing into the lacrimal sac, even though
`inert, must be avoided.
`
`The plug is designed to “fail safe,”
`so to speak, and if any movement
`oc—
`curs after insertion, it should be to ex—
`trude. This results in more extrusions,
`but it is a simple matter to reinsert an—
`other plug.
`
`The. right fit of the barb may account
`for some of the success of
`the plug.
`Although the neck was designed to block
`lacrimal excretion at the punctal open-
`ing,
`the barb may be doing a more ef—
`ficient
`job at
`the canalicular level.
`
`the advantages in having a
`One of
`reversible closure of
`the punctum is
`demonstrated in the dry eye state that
`occurs during temporary use of diuret—
`ics, some tranquilizers and other medie
`cations.
`\When these medications are
`
`withdrawn, and the dry eye becomes
`more moist,
`it
`is easy to remove the
`punctum plug if so desired.
`
`Great care must be used to gently di—
`late the punctum without breaking the
`punctum ring. The subsequent loose or
`sloppy fit until the punctum heals prob—
`ably accounts
`for
`some of
`the early
`losses of the punctum plug. A punctum
`dilator was made from Teflon which
`
`allOW—
`the tip,
`was partially flexible at
`it
`is
`ing for a more gentle dilation.
`times
`probably better
`to stop several
`during the dilation and try to insert the
`plug, thus gradually increasing the ex
`perience of
`the ophthalmologist
`in a
`safe manner.
`
`A modified dilator was also made to
`
`allow dilation of the punctum to a pre~
`set diameter of 1.2 mm. This should
`
`prevent over dilation of the punctum in
`the future.
`
`Insertion was usually done under the
`operating microscope, although slitrlamp
`
`and
`observation,
`loupe
`observation,
`gross observation have and can be tied.
`After insertion the patient is told that
`discomfort following insertion is usually
`transient and aspirin or similar
`anal—
`gesics is sufficient. The patient
`is usu»
`ally seen within a week and told to con»
`tinue his dry eye drops and ointment
`as needed. Usually the medication rou»
`tine is greatly reduced.
`
`SUM MARY
`
`The problem of a chronic dry eye
`was approached with the idea of con»
`serving the basal state of tears by in—
`serting a plug to block the lacrimai out-
`flow. The involved anatomy, punctum
`plug design, method of
`insertion, and
`postinsertion
`instructions were
`dis—
`cussed.
`
`three patient groups
`The results of
`were given and failures discussed. Suc—
`cess in the test group fell between 50%
`to 75%. Successful
`insertion an]
`ac—
`ceptance of
`the punctum plug should
`probably exceed 75% in clinical prac—
`tice.
`
`Key Words: Dry eye; keratoconjunctivi-
`tis sicca; Sjb'gren’s syndrome; pllr‘“ttum;
`punctum plug; reversible therapy.
`
`REFERENCES
`
`l. Stallard 1113: Eye Surgery, ed 2. Balti—
`more, VVilliams 87 Wilkins Co, 1950, p 260.
`
`2. Trevor—Roper PD: OphHmhrtalaggx; A
`Textbook for Diploma Students. Chicaga
`Year Book Medical Publishers, 1932, PP
`331—332.
`
`3, ~Tones LT, Marquis MM, Vincent,
`Lacrimal
`function. Am. J 017122710117:
`6587659, 1972.
`
`v.’
`
`IST
`'3'
`
`4.
`
`U1
`
`Jones LT: Anatomy of the tear system. 1W
`Ophthalmol Clrz'n 13:16—19, 1973.
`
`\Volff E: Anatomy of the Eye and Orbit)
`ed 6. Philadelphia, VVB Saunders Ct
`1968'
`pp 228-239.
`
`APOTEX 1014, pg. 7
`
`
`
`APOTEX 1014, pg. 7
`
`

`

`Von M 70
`xov-xwx 1973
`'
`,
`' ”
`'
`/(
`rmc DM.
`[he dynamus and (11 (image
`19:11:13“- Int ()phtlmlmol Clin 132111, 1973‘
`
`6'
`
`'
`/.
`
`the Eye. St
`: Ph m‘iology of
`7
`'
`A
`3
`11:1
`AxCu-Cl
`Loms, LV' Moshy Co. 1965, p 36.
`
`PUNCTUM PLUG
`
`013-879
`
`___"y"—
`
`APOTEX 1014, pg. 8
`
`APOTEX 1014, pg. 8
`
`