TRANSACTIONS
`
`AMERICAN ACADEMY
`of
`OPHTHALMOLOGY
`and
`OTOLARYNGOLOGY
`
`SECTION ON OPHTHALMOLOGY
`
`VOLUME 79
`NUMBER 1
`
`JANUARY- FEBRUARY
`1 9 7 5
`
`Copyright © 1975 by the A merican 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.
`
`APOTEX 1014, pg. 1
`
`

`

`1LIRAN§ACTION§
`American Academy of Oplhtitllunlmo!ogy and Oitolaryngo!ogy
`
`VoLUME 79
`
`JANUARY- FEBRUARY 1975
`
`NuMBER 1
`
`ED ITORIAL BOARD
`
`W. Howard Morrison, Omaha, Editor-in-Chief
`
`Clair M. Kos, Iowa City, Business j;J anager
`
`D. Thane R. Cody, Rochester, Minn, Associate Editor for Otolaryngology
`
`Stanley M. Truhlsen, Omaha, Associate Editor for 0 phthalmology
`
`B oard of Secretaries: Frederick C. Blodi, Eugene L. Derlacki, Brian F . McCabe,
`
`George F. Reed, David Shoch, Bruce E . Spivey
`
`Business and Editorial Offices
`
`American Academy of Ophthalmology and Otolaryngology
`
`15 Second St SW, Rochester, Minn 55901
`
`APOTEX 1014, pg. 2
`
`

`

`THE PUNCTUM PLUG:
`EVALUATION OF A NEW TREATMENT FOR THE DRY EYE
`
`}ERRE 1'virNOR FREEMAN, MD
`MEMPHIS, TENNESSEE
`
`KERATITIS sicca, or keratoconjunctivi(cid:173)
`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 suc(cid:173)
`in more extreme cases, such as
`cess
`s j ogren' s syndrome. 1•2
`This paper describes a method of
`closing the punctum and canaliculus by
`a plug which can be removed if un-(cid:173)
`desirable results occur. Jones et aP in
`1972 devised a
`tapered polyethylene
`tube or cone to temporarily occlude ei(cid:173)
`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(cid:173)
`per and lower lids about 6 mm from
`the medial canthus. These are round
`or slightly ovoid openings approximate(cid:173)
`ly 0.3 mm in size. This opening is sur(cid:173)
`rounded by a fairly dense, relatively
`ring of
`tissue
`avascular connective
`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 mm
`to join the other canaliculus before en(cid:173)
`tering the lacrimal sac. Th e canaliculi
`are about 0.5 mm in diameter, lined by
`
`From the University of Tennes see M ethodist Hospi(cid:173)
`tal, l\1emphis.
`
`P resented at the Seventy-ninth Annua l Meeting of the
`Amel"ican Academy of Ophthalmology and Otol ar yn(cid:173)
`gology, D allas, Oct 6- 10, 1974.
`
`sur(cid:173)
`epithelium
`squamous
`stratified
`rounded by elastic tissue, allowing the
`canaliculi to be easily dilated to three
`times normal size.4,5
`
`Although some authors6•7 have sug(cid:173)
`gested that the punctum has a sphincter
`ring of muscle, L. T. Jones, MD (per(cid:173)
`sonal communication, 197 4), believes
`that practically speaking there is no
`muscle sphincter, but that the wall of
`the punctum is much like that of the
`canaliculi, consisting of a fibroelastic
`band of tissue. This band or ring of
`connective tissue is the structure that
`is dilated with great care and gentle(cid:173)
`ness, as described later in this report.
`
`METHODS AND MATERIALS
`
`The punctum plug, or the device to
`close the punctum, is designed to com(cid:173)
`pletely close
`the punctum opening.
`It has a slightly larger portion pro(cid:173)
`jecting
`into
`the vertical portion of
`the canaliculus that prevents the plug
`from extruding or coming out, and a
`larger, smooth head at the opening that
`prevents the plug from passing down
`into the canaliculus. The head is ap(cid:173)
`proximately 1.5 to 2 mm in diameter
`and 0.7 mm high. Having the head
`smooth and dome-shaped allows it to
`rest in the lacrimal lake and against
`conjunctiva and cornea with little irr~­
`tation. The neck or waist is approxi(cid:173)
`mately 0.7 mm in diameter and 1.5 mm
`in length. This connects to the large~
`tip or barb which is 1 mm long an
`l.Z to 1.9 n;m in diameter, coming to a
`flat point 0.5 rnm across.
`
`OP-874
`
`APOTEX 1014, pg. 3
`
`

`

`'
`voLUME 79
`NOV-DEC 197)
`Materials considered for this device
`were silicon, Teflon, methyl methacrylate,
`hydroxyethylmethacrylate
`(HEM A),
`and inert metals. Two materials were
`initially selected for _ their availability
`and proved high
`tissue
`tolerance:
`HEMA and Teflon.
`
`HEMA showed excellent patient and
`tissue acceptance. In the dry state its
`firmness helped to ease the process of
`insertion, and it became almost imme(cid:173)
`diately soft and flexible as tears or drops
`Its approximate 28 o/a
`moistened
`it.
`swell rate when moistened undoubted(cid:173)
`ly helped close the punctum more ef(cid:173)
`fectively. T he tensile strength of HEMA
`is a drawback, in that manipulation by
`a patient's
`finger can contribute
`to
`breakage.
`
`Teflon also has excellent tissue toler(cid:173)
`ance, and it has had good patient ac(cid:173)
`ceptance after the design was perfected.
`The material strength is excellent. Both
`HEMA 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
`anesth etic and placed into the medial
`canthal area for five to ten minutes.
`Then a punctum dilator is carefully
`used to slowly dilate the punctum to
`about 1.2 mm without breaking the
`punctum connective tissue ring. Break(cid:173)
`ing this ring or splitting the punctum
`encourages a loose or sloppy fit and sub(cid:173)
`sequent extrusion or loss of the plug.
`
`Quickly after removing the dilator,
`the punctum 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(cid:173)
`tion and passage into the canaliculus.
`As soon as the head is seated at the
`punctum opening, a shearing or wob(cid:173)
`bling motion disengages
`the
`inserted
`punctum plug.
`
`PUNCTUM PLUG
`
`OP-875
`
`For removal, the head of the plug or
`the neck just under the head is grasped
`·with forceps. If topical anesthetics do
`not relieve discomfort enough here, lido(cid:173)
`caine hydrochloride or similar anesthetic
`can be inj ected 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(cid:173)
`fering from symptomatic keratoconjunc(cid:173)
`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(cid:173)
`tients who had early extrusion before
`the design previously described was se(cid:173)
`lected.
`
`RESULTS
`
`A group of seven patients had a
`HEMA punctum plug placed into one
`lower punctum. Although there was var(cid:173)
`iation of expression of comfort, all pa(cid:173)
`tients accepted the plug and expressed
`that the involved eye became more com(cid:173)
`fortable than the fellow eye. Some pa(cid:173)
`tients could feel the plug at times, espe(cid:173)
`turned
`the cornea was
`cially when
`toward the punctum plug, but there was
`no discomfort. One plug had broken at
`approx imately one week, and the rest
`of the plug was expressed from the
`canaliculus. Another plug, that appar(cid:173)
`ently did not seat well from the begin(cid:173)
`ning and projected from the punctum,
`showed some mild surrounding conjunc(cid:173)
`tival inj ection, probably from excessive
`movement of the plug. This plug was
`removed at six weeks, although the pa(cid:173)
`tient had expressed no complaints. Af(cid:173)
`ter removal, the patient stated her in(cid:173)
`volved eye felt worse for about five
`days, but it symptomatically became sim-
`
`APOTEX 1014, pg. 4
`
`

`

`OP-876
`
`JERRE MINOR F REEMAN
`
`TRAM A CAD
`OPHTH & OTOL
`
`ilar to her fellow dry eye, thus showing
`the reversible facet of this treatment
`both in the ability to remove the punc(cid:173)
`tum plug if desired and in the treated
`eye showing comfort, then discomfort
`upon removal.
`
`Four HE1\1A plugs came out inad(cid:173)
`vertently, probably during sleep. T wo
`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 th eir plug.
`T he one remaining patient is still tol(cid:173)
`erating the plug as of this date and con(cid:173)
`tinues to report improvement in symp(cid:173)
`tom s.
`
`A second group of 12 patients had
`insertion of a T eflon plug of similar
`design as the first HEMA plug. Un(cid:173)
`like the HEMA plug, where there is al(cid:173)
`most 100% comfort, the initial T eflon
`plug was reported to be irritating by
`25 % of the patients in this group. Ob(cid:173)
`jectively, in two patients there was mild
`fluorescein staining on the cornea, where
`the cornea touched the plug head on
`rotating nasally. Without BEMA's
`Hexibility, 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 di s(cid:173)
`comfort. One patient had the plug ex(cid:173)
`trude or fall out. The remaining seven
`patients are doing well.
`
`The third group of patients had a
`redesigned, smaller T eflon plug insert(cid:173)
`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(cid:173)
`ceived, with comfort being acceptable
`by all patients and obj ectively there be(cid:173)
`ing no staining of the conjunctiva or
`cornea.
`
`out or plugs fell out between one and
`three weeks. All four of these patients
`had had a larger Teflon or HEMA plug
`the
`inserted previously, and possibly
`punctum was still dilated from this, en(cid:173)
`com-aging a looser fit and subsequent
`loss. The remaining nine patients re(cid:173)
`ported increased or acceptable comfo rt
`of the dry eye and are doing well 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(cid:173)
`fort of the three different plugs. T hey
`reported increased comfort of the treat(cid:173)
`ed eye over that of the untreated eye.
`The HEMA plug and the smaller T eflon
`plug were reported as the more com(cid:173)
`fortable designs.
`
`Four patients after having one punc(cid:173)
`tum plug inserted with comfort, request(cid:173)
`ed the insertion of a punctum plug in
`the fellow eye. O ne punctum plug was
`placed in one upper punctum, but came
`out overnight mainly due to a loose fit.
`All work in this report was done with
`the
`lower punctum. Thirty-two eyes
`were treated in this study. T wenty-six
`patients were · female and six patients
`were male. Average age was 54 years.
`
`1\/[ost of the work reported in this
`paper was carri.ed out during the spring,
`summer, and fall in the mid-South area
`when heating was not necessary, al(cid:173)
`lowing the sufferers of keratoconjunc(cid:173)
`tivitis sicca to generally do their best.
`It is entirely possible that the lower
`humidity and dry heat experienced dur(cid:173)
`ing the winter would have shown an
`even greater patient symptomati differ(cid:173)
`ence between the treated eye and the
`nontreated eye.
`
`CONCLUSIONS
`
`Of the 13 patients in group 3, four
`had had their plugs inadvertently wiped
`
`In every case except where t ere was
`initial discomfort, the punctum plugs
`
`APOTEX 1014, pg. 5
`
`

`

`VOL U M E 79
`NO V· DEC 19 75
`
`PUNCTUM PLUG
`
`OP -877
`
`were tolerated by all patients with im(cid:173)
`provement in symptoms in the treated
`eye. Obj ective tests for improvement
`were not done in this work There were
`no instances of infection, although dis(cid:173)
`corr.fort required removal of the plug
`in six
`instances. One plug head had
`broken, requiring removal of the plug.
`All success ful patients reported a de(cid:173)
`crease in the need for drops or oint(cid:173)
`ment. Epiphora occasionally occurred
`in some patients but was a transient
`problem. Early morning mucous strands
`or "matter" was a problem in a few in(cid:173)
`these same patients
`stances. Usually
`stated they frequently had mucus strings
`before insertion of a punctum plug.
`These same patients were cautioned not
`to accidentally wipe
`their plug out.
`Overall success rate was SO o/o to 75 o/o .
`vVith selection of patients, use of the
`more refined design, and avoidance of
`overdilating, clinical experience should
`exceed 75o/o success rate.
`Other than comfort, improved visual
`acuity might be a benefit experienced by
`some patients. Although visual acuity
`was not measured as a parameter in
`thi s work, 3 of the 32 eyes showed an
`improvement in acuity of at least one
`line.
`
`Visual acuity is dependent upon the
`optically smooth precorneal tear film.
`Any condition such as a dry eye that
`compromises
`this film contributes
`to
`poorer acuity. Any therapy that pro(cid:173)
`motes the preservation, stabillty, and in(cid:173)
`tegrity of this tear film should, in · turn,
`improve visual acuity.
`
`DISCUSSION
`
`syndrome, possibly antibiotic
`gren's
`drops in low dosage should be used.
`
`The primary indication for this ther(cid:173)
`apy is the clinical dry eye, although it
`was used in two eyes with mild S jo(cid:173)
`gren's syndrome. Other possible indi(cid:173)
`cations include the longtime contact lens
`wearer with developing dry eye ; pre(cid:173)
`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 echothio(cid:173)
`phate iodide or other therapy, the punc(cid:173)
`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(cid:173)
`the punctum plug could
`neal ulcers,
`prevent fluid and medication from en(cid:173)
`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.
`
`T he success rate of this mode of ther(cid:173)
`apy probably will depend in part upon
`similar factors controlling contact lens
`success. If the patient has sufficient re(cid:173)
`ward (such as a more comfortable moist
`eye) for tolerating the plug, then suc(cid:173)
`cess will be high. If the plug causes
`discomfort to exceed the comfort gained,
`then there is no reason to tolerate th e
`include plug de(cid:173)
`plug. Other factors
`sign and material acceptance, but, hope(cid:173)
`fully, this has evolved to a manage(cid:173)
`C'lble stage.
`
`The punctum plug probably acts to
`three layers of
`the tear
`preserve all
`film:
`the mucin, the aqueous, and the
`lipid components. No doubt, lysozyme
`helps to prevent infection in the simple
`!<eratitis sicca eye. If the plug is used
`tn lysozyme deficient eyes such as S j o-
`
`A fter the plug head broke in the pa(cid:173)
`tient in group 1, the remainder of the
`plug remained quite stationary and did
`not move down the canaliculae. The
`barb, once seated, no doubt,
`is held
`tightly by the elastic tissue of the canalic(cid:173)
`uli and resists movement in either di-
`
`APOTEX 1014, pg. 6
`
`

`

`OP-878
`
`JERRE MINOR FREEMAN
`
`TRA M A CAD
`OPHTH & OTOL
`
`rection. This is highly desirable because
`the complication of a foreign body pass(cid:173)
`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(cid:173)
`curs after insertion, it should be to ex(cid:173)
`trude. This results in more extrusions,
`but it is a simple matter to reinsert an(cid:173)
`other plug.
`
`The tight 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(cid:173)
`ing, the barb may be doing a more ef(cid:173)
`ficient job at the canalicular level.
`
`One of the advantages in having a
`reversible closure of the punctum is
`demonstrated in the dry eye state that
`occurs during temporary use of diuret(cid:173)
`ics, some tranquilizers and other medi(cid:173)
`these medications are
`cations. When
`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(cid:173)
`late the punctum without breaking the
`punctum ring. The subsequent loose or
`sloppy fit until the punctum heals prob(cid:173)
`ably accounts for some of the early
`losses of the punctum plug. A punctum
`dilator was made from T eflon which
`W?S partially flexible at the tip, allow(cid:173)
`ing for a more gentle dilation . It is
`to stop several times
`probably better
`during the dilation and try to insert the
`plug, thus gradually increasing the ex(cid:173)
`perience of the ophthalmologist in a
`safe manner.
`
`A modified dilator was also made to
`allow dilation of the punctum to a pre(cid:173)
`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 slit-lamp
`
`and
`loupe observation,
`observation,
`gross observation have and can be used.
`After insertion the patient is told that
`discomfort following insertion is usually
`transient and aspirin or similar anal(cid:173)
`gesics is sufficient. The patient is usu(cid:173)
`ally seen within a week and told to con(cid:173)
`tinue his dry eye drops and ointment
`as needed. Usually the medication rou(cid:173)
`tine is greatly reduced.
`
`SUMMARY
`
`The problem of a chronic dry eye
`was approached with the idea of con(cid:173)
`serving the basal state of tears by in(cid:173)
`serting a plug to block the lacrimal out(cid:173)
`flow . The involved anatomy, punctum
`plug design, method of insertion, and
`instructions were dis(cid:173)
`postinsertion
`cussed.
`
`The results of three patient groups
`were given and failures discussed. Suc(cid:173)
`cess in the test group fell between 50%
`to 7 5 o/o . Successful insertion and ac(cid:173)
`ceptance of the punctum plug should
`probably exceed 75 o/o in clinical prac(cid:173)
`tice.
`
`Key Words: Dry eye; keratoconj unctivi(cid:173)
`tis sicca; Sjogren's syndrome; punctum;
`punctum plug; reversible therapy.
`
`REFERENCES
`
`1. Stallard HB: Eye s~wgery, ed 2. Balti(cid:173)
`more, W illiams & Wilkins Co, 1950, p 260.
`2. Trevor-Roper PD : 0 phthal1nology ; A
`Textbo ok for D iploma S tudents. Chicago,
`Year Book Medical Publishers, 1962, PP
`331-332.
`3. Jones L T, Marquis MM, Vincent NJ :
`Lacrimal function. Am, .T Ophthalm ol 73:
`658-659, 1972.
`4. Jones L T: Anatomy of the tear system. Int
`Ophthalmol Clin 13:16-19, 1973.
`5. Wolff E: Anatomy of the Eye and Orbit,
`ed 6. Philadelphia, WB Saunders Co. 1968,
`pp 228-239.
`
`APOTEX 1014, pg. 7
`
`

`

`VOL UM E 79
`NOV-DEC 19 7 5
`
`PUNCTUM PLUG
`
`OP-879
`
`6. Maurice DM : The dynamics and drainage
`of tears. I nt 0 phthalmol C lin 13: 111 , 1973.
`
`the Eye. St
`7. Adler FH: Physiology of
`Louis, CV Mosby Co, 1965, p 36.
`
`\
`I
`I
`I
`I
`
`\
`
`APOTEX 1014, pg. 8
`
`