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Silicone Versus Collagen Plugs for Treating Dry Eye: Results of a Prospective Randomized Trial Including Lacrimal Scintigraphy
Silicone Versus Collagen Plugs for Treating Dry Eye: Results of a Prospective Randomized Trial Including Lacrimal Scintigraphy RANA ALTAN-YAYCIOGLU, MD, E. ARZU GENCOGLU, MD, YONCA AYDIN AKOVA, MD, DILEK DURSUN, MD, FETHI CENGIZ, MD, AND AHMET AKMAN, MD
● PURPOSE:
To compare the short-term efficacy of collagen and silicone plugs for treating dry eye using quantitative lacrimal scintigraphy. ● DESIGN: Prospective randomized clinical trial. ● METHODS: In this institutional study, 24 dry eye patients were evaluated in two groups: group I (n ⴝ 22 eyes) received collagen plugs and group II (n ⴝ 26 eyes) received silicone plugs. Comparisons were made with normal control subjects (n ⴝ 22 eyes). Data for the Schirmer I test, tear break-up time, and ocular surface staining with rose bengal dye were recorded before and after punctal occlusion. Lacrimal scintigraphy was performed at each time point, and the time to half maximum activity on the ocular surface (T1/2), and the percentage retention of activity on the ocular surface at the end of the dynamic study (RI) were recorded. ● RESULTS: In both patient groups, Schirmer I results, tear break-up times, and rose bengal staining scores improved significantly after plug insertion. Mean T1/2 values and RI values increased significantly in both groups (P < .0001 for both). The differences for these values between groups I and II was statistically insignificant (P > .05). ● CONCLUSIONS: Collagen and silicone plugs both resulted in significant increases in aqueous tear volume, half-life of nuclear material on the ocular surface, and percentage of nuclear material retention. The groups’ post-insertion values for all parameters were similar. These results suggest that these two plug types have similar efficacy as treatments for dry eye in the short term. Further studies evaluating Accepted for publication Feb 11, 2005. From the Department of Ophthalmology (R.A.-Y.), Adana Teaching and Medical Research Center, Baskent University Faculty of Medicine, Adana, and Departments of Nuclear Medicine (E.A.G.) and Ophthalmology (Y.A.A., D.D., F.C., A.A.), Baskent University Faculty of Medicine, Ankara, Turkey. Inquiries to Yonca A. Akova, MD, Baskent University Faculty of Medicine, Department of Ophthalmology, Fevzi Cakmak Cad, 10. Sok, No: 45, 06490, Bahcelievler, Ankara, Turkey; fax: (⫹90) 312-223-7333; e-mail: [email protected]
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long-term results are required. (Am J Ophthalmol 2005; 140:88 –93. © 2005 by Elsevier Inc. All rights reserved.)
D
RY EYE SYNDROME, OR KERATOCONJUNCTIVITIS
sicca, develops as a result of deficient tear secretion or increased evaporation of tears and involves damage to the ocular surface and considerable discomfort.1 When treating dry eye, the aim is to reduce pain, restore a smooth ocular corneal surface, protect the cornea from further damage, and keep tears on the ocular surface longer. Artificial tear solutions are the most widely used therapy for dry eye syndrome. Topical corticosteroids, mast cell stabilizers, and anti-histaminics are used to treat underlying or accompanying disorders.2 Use of soft contact lenses, insertion of plugs in the lacrimal puncta (punctal plugs), and humidifier face masks are some of the other options.2,3 However, prolonged use of contact lenses can actually cause dry eye, and use of contacts in the setting of dry eye may increase the risk of corneal infection. Punctal plug treatment is indicated for dry-eye patients who are using artificial tears but still have complaints and for those who cannot instill eyedrops frequently enough.4 The plugs are made of absorbable material (collagen, gelatin, catgut, or hydroxypropyl methyl-cellulose) or non-absorbable material (silicone, polymethylmethacrylate, polyethylene, and N-butyl cyanoacrylate). There are various designs and models of punctal plugs, and most are excellent for treating dry eye. Absorbable plugs are used before attempting permanent occlusion to observe whether the patient will be able to tolerate the epiphora. Conversely, non-absorbable plugs are used when permanent occlusion of the punctae is needed.2 Rossomondo and coworkers5 introduced lacrimal scintigraphy in 1972. This technique is a simple, non-invasive way to evaluate the lacrimal system. It is most often used to assess the physiologic function of the lacrimal system when investigating epiphora and to evaluate the success of dacryocystorhinostomy.6 – 8 With lacrimal scintigraphy, it is possible to assess the dynamics of lacrimal drainage, the
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permeability fraction of the nasolacrimal canal, tear clearance time, and changes in the percentage of interpalpebral nuclear material activity over time.9 –10 In addition, use of computer-assisted gamma cameras with this technique enables the examiner to generate quantitative outflow curves that illustrate tear drainage over time and also to analyze partial obstruction of the nasolacrimal system.11 In this study, we used lacrimal scintigraphy to compare two types of punctal plugs with respect to their effects on tear volume and ocular surface tear retention time. We put collagen and silicone punctal plugs, as absorbable and non-absorbable plugs that we routinely use in our clinical practice, and evaluated the short-term effects of these plugs.
PATIENTS AND METHODS THIS PROSPECTIVE RANDOMIZED CLINICAL TRIAL WAS
conducted in accordance with the Declaration of Helsinki. Local ethics committee approval was obtained. Each patient was informed about the nature and use of punctal plugs and about the process of lacrimal scintigraphy. All subjects gave written informed consent to participate. The study was conducted in the Ophthalmology and Nuclear Medicine Departments of Baskent University. ● PATIENT POPULATION: Included in the study were 24 consecutive patients (21 women and three men; 48 eyes total) who had been diagnosed with aqueous tear deficiency. All had been using artificial tears, and none had shown subjective or objective improvement in dry eye with these medications. None of the patients had eyelid or blinking problems (that is, evaporative dry eye), and none had previously undergone punctal plug insertion or nuclear scintigraphy. The 24 patients were randomized into two groups. Patients in group I (n ⫽ 11; nine women, two men; 22 eyes) had a collagen plug inserted in the lower punctum of each eye, and patients in group II (n ⫽ 13; 12 women, one man; 26 eyes) had silicone plugs inserted in both lower puncta. Because the lower punctum is usually larger than the upper and drains a greater amount of tears,12 plugs were placed only in the lower punctum. Eleven age- and gender-matched control subjects with no ocular disorders (group III; nine women, two men; 22 eyes) also underwent tear testing and lacrimal scintigraphy for comparison with the patient groups. Mean age (⫾ SD) of groups I, II, and III were statistically similar, at 65.09 ⫾ 11.64 years, 63.69 ⫾ 13.24 years, and 68.63 ⫾ 2.80 years, respectively (P ⬎ .05). ● STUDY PROCEDURE:
Aqueous tear production was assessed with the Schirmer I test. Topical anesthetic was applied, a Whitman filter paper (Alcon Laboratories, Fort Worth, Texas) was placed in the lower conjunctival sac,
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and the measurement at 5 minutes was recorded. Tear film stability was estimated based on tear break-up time (TBUT). A fluorescein-impregnated strip wetted with non-preservative saline solution was placed in the lower conjunctival sac. After one blink, the time to appearance of the first non-stained spot in the stained tear film was recorded. Ocular surface staining was performed only in the patient eyes (groups I and II). This testing was done using a rose bengal strip (Barnes-Hind, Akorn, Abita Springs, Louisiana) and was carried out before and 3 days after the collagen or silicone plugs were inserted. Ocular surface staining was assessed using a rose bengal grading system developed by van Bijsterveld,13 and each eye was scored separately. Nasal bulbar conjunctival staining, temporal bulbar conjunctival staining, and corneal staining were each graded on a four-tier scale: 0 ⫽ no staining, 1 ⫽ mild staining, 2 ⫽ moderate staining, and 3 ⫽ extensive staining. A total staining score greater than 3 of 9 was accepted as keratoconjunctivitis sicca. All 35 subjects underwent lacrimal scintigraphy, and the same nuclear medicine specialist (E.A.G.), who was masked to the patients’ groups, evaluated each set of images. The images were quantitatively analyzed according to activity transition and radioactive field calculations made with a computer-based program. A dual-headed gamma camera (Siemens e.cam, Erlangen, Germany) was used. For each scan, 200 Ci of technetium-99m pertechnetate in 20 l isotonic saline was applied to the ocular surface by micropipette. The subjects were asked to continue normal blinking while the images were taken. Immediately after the radioactive tracer was applied, a dynamic sequence of images was obtained at 30-second intervals for 30 minutes in a 64 ⫻ 64 matrix. Subjects in group III (control subjects) underwent scintigraphy only once. Those in groups I and II had two series of images taken: an initial set before punctal plug insertion, and a second set 3 days after the plugs were in place. In each scintigraphy session, we recorded the time required for half of the nuclear material (99Tc), as measured by the gamma camera, to be cleared from the ocular surface (T1/2). In the patient groups, the percentage of activity that remained on the ocular surface at the end of the dynamic study (RI) was calculated. When the procedure was complete, the eye was rinsed with saline, and antibiotic drops were applied. As noted, collagen or silicone plugs were inserted in the lower puncta of the 48 patient eyes. Before placing each plug, one drop of topical anesthetic (proparacaine hydrochloride 0.5%, Alcon, Puurs, Belgium) was applied to the site. The collagen plugs were made of cow collagen (Lacrimedics, Eastsound, Washington), and the largest size that would fit in the punctum was chosen. Punctum size was measured using a punctal probe. The diameters of the collagen plugs used were 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, and 0.6 mm, and all were 1.75 mm in length. Similarly, the patients who received silicone punctal plugs
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FIGURE 1. The mean Schirmer I values before and after insertion of punctal plugs in the patient groups. Group I ⴝ eyes with collagen plugs inserted; group II ⴝ eyes with silicone plugs inserted.
FIGURE 3. The rose bengal scores before and after insertion of punctal plugs in the patient groups. Group I ⴝ eyes with collagen plugs inserted; group II ⴝ eyes with silicone plugs inserted.
FIGURE 2. The tear film breakup time (TBUT) for before and after insertion of punctal plugs in the patient groups. Group I ⴝ eyes with collagen plugs inserted; group II ⴝ eyes with silicone plugs inserted.
FIGURE 4. The mean time to half maximum activity (T1/2) value for the control group and the mean T1/2 values for before and after insertion of punctal plugs in the patient groups. Group I ⴝ eyes with collagen plugs inserted; group II ⴝ eyes with silicone plugs inserted.
(Odyssey-Parasol Punctal Occluder A14 to 203, Memphis, Tennesee) had the largest size possible inserted. Small (0.35 to 0.65 mm), medium (0.60 to 0.85 mm), and large (⬎0.90 mm) silicone plugs were inserted.
After plug insertion, the mean Schirmer I value in group I increased to 5.77 ⫾ 0.75 mm, and that for group II increased to 5.96 ⫾ 0.87 mm. The rise observed in each patient group was statistically significant (P ⬍ .0001 for both), but the group I and II Schirmer I values after insertion were similar (P ⬎ .05). The mean TBUT findings before plug insertion in groups I and II were similar (Figure 2), at 5.50 ⫾ 1.25 and 5.42 ⫾ 1.42 seconds, respectively (P ⬎ .05). The mean TBUT in the control group was 14.2 ⫾ 3.50 seconds, which was statistically significantly longer than the mean TBUT in both patient groups (P ⬍ .05 for both). After plug insertion, TBUT increased to 12.20 ⫾ 2.50 seconds in group I, and to 12.40 ⫾ 2.50 seconds in group II. Both these increases were statistically significant (P ⬍ .0001 for both), but there was no difference between the groups I and II TBUT findings after insertion (P ⬎ .05). For rose bengal staining of the ocular surface, before plug insertion the mean staining scores in groups I and II were 6.63 ⫾ 0.84 and 6.61 ⫾ 0.89, respectively (P ⬎ .05) (Figure 3). Three days after plug insertion, the scores had dropped to 1.90 ⫾ 0.81 and 2.07 ⫾ 0.79, respectively.
● STATISTICAL ANALYSIS:
Data were statistically analyzed using the program SPSS 11.5 for Windows. Group results were compared using the Student’s t test and one-way analysis of variance (ANOVA). As the post hoc test, Tukey HSD (honestly significantly difference) Method was used. The Wilcoxon signed-rank test was used to compare the results for ocular surface staining with Rose Bengal stain, the Schirmer I values, and the TBUT findings before and after punctal plug insertion.
RESULTS NONE OF THE PATIENTS DEVELOPED ADVERSE EVENTS RE-
lated to the procedure. Before plug insertion, the mean Schirmer I values in groups I (collagen plugs) and II (silicone plugs) were 1.35 ⫾ 0.49 mm and 1.38 ⫾ 0.49 mm, respectively, and the mean in group III (control subjects) was 12 ⫾ 2.06 mm (Figure 1). The pre-insertion Schirmer I values in the patient groups were similar; however, both these means were statistically significantly lower than the mean in group III (P ⬍ .0001 for both). 88.e3
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FIGURE 5. The mean percentages of nuclear material retained at the completion of the scintigraphy for the control group, and for before and after insertion of punctal plugs in the patient groups. Group I ⴝ eyes with collagen plugs inserted; group II ⴝ eyes with silicone plugs inserted; group III ⴝ control eyes.
Both these decreases within groups were statistically significant (P ⬍ .0001 for both). However, the groups’ scores at this stage (recovery) were statistically similar (P ⬎ .05). The T1/2 results for the three groups are shown in Figure 4. Before plug insertion, the mean T1/2 values for groups I and II were similar, at 14.50 ⫾ 6.24 minutes and 15.64 ⫾ 6.30 minutes, respectively (P ⬎ .05). The mean in group III was 4.22 ⫾ 1.26 minutes, and this was statistically significantly shorter than both the patient groups’ preinsertion values (P ⬍ .0001 for both). After plug insertion, the mean T1/2 values in groups I and II increased to 24.50 ⫾ 8.00 minutes and 24.43 ⫾ 7.66 minutes, respectively. Both these increases were statistically significant (P ⬍ .0001 for both). Comparison of the changes in the group T1/2 values from before to after plug insertion between the two groups revealed no statistically significant difference (P ⬎ .05). Before plug insertion, the findings for mean RI in groups I and II were 45.35 ⫾ 19.39% and 44.50 ⫾ 16.75%, respectively (P ⬎ .05; Figure 5). The corresponding result for the control group was 14.27 ⫾ 2.67%, which was statistically significantly lower than the percentages in both patient groups (P ⬍ .0001 for both). After plug insertion, mean RI in groups I and II rose to 68.64 ⫾ 12.77% and 62.12 ⫾ 17.86%, respectively. Both these increases were statistically significant (P ⬍ .0001 for both), but comparison of the changes in group RI values from before and after plug insertion revealed no statistically significant difference (P ⬎ .05).
DISCUSSION PUNCTAL OCCLUSION HELPS PATIENTS RETAIN BOTH NAT-
ural and artificial tears on the ocular surface. Blocking the lacrimal punctum impedes the outflow of tears, thereby increasing the aqueous tear component and keeping natVOL. 140, NO. 1
ural tears on the ocular surface.14 This occlusion can be achieved with various surgical, thermal, and tamponade methods.2,15 Although surgery is rarely used, punctum patching with conjunctival tissue is the most common surgical technique for this purpose because it is reversible. Thermal methods involve occluding the punctum by damaging and shrinking the canalicular walls by laser, cautery, or diathermy. In tamponade techniques, a foreign body is inserted to block the drainage system. This is the most popular method for achieving punctal occlusion because no surgery is required and the results are reversible. Freeman16 was the first to use punctal plugs to treat dry eye. Plugs made of collagen have the advantage of easy insertion and relatively rapid spontaneous dissolution (within approximately 2 weeks); however, these plugs do not provide total occlusion or long-term cure.17 In contrast, silicone plugs may remain intact for 6 months or more and are easy to remove when desired.4 The issue with this type of plug is that long-term exposure to the foreignbody material can result in irritation-related complications.18 –20 The lower punctum often plays a greater role in tear drainage.12 Thus, we put the punctal plugs only on the lower puncta to observe the role of the lower punctal occlusion. In this study, we quantitatively evaluated and compared the efficacy of collagen and silicone punctal plugs using lacrimal scintigraphy. Because collagen plugs dissolve in a short time, we preferred to perform the scintigraphy at day 3, before the dissolving of the collagen, and aimed to investigate the effects in the short term. The data indicate that these two types of plugs yield similar results in the short term. White and associates assessed 17 lacrimal systems of 12 normal subjects and showed that blinking affects tear elimination.21 Using lacrimal scintigraphy, they demonstrated that simple eyelid closure for 2 minutes significantly slowed tear drainage. Because the aim of our study was to evaluate the efficacy of punctal plugs for treating , we excluded subjects with blink disorders or evaporative dry eye. We also instructed all subjects to continue normal blinking during the scintigraphy procedure to prevent any disruption of nuclear material drainage related to lid closure or rapid blinking. A control group was included in the study to observe the clinical significance of lacrimal scintigraphy and investigate the correlation of scintigraphy with the objective examinations such as Schirmer and TBUT. Previous investigations of punctal plug use have demonstrated increased aqueous tear component, increased goblet cell density, improved rose bengal and fluorescein ocular staining, and decreased tear osmolarity.22,23 Sakamato and associates24 studied the efficacy of silicone punctal plugs in dry-eye patients with and without Sjögren syndrome. After the plugs were inserted, the Sjögren group showed greater improvement in rose bengal staining scores than the non-Sjögren group. Dursun and associates25 studied 18 patients with dry eye who underwent punctal
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decreased tear drainage. Compared with the control group, we found that the patients with dry eye had longer T1/2 values and higher percentages of nuclear material retention. The quantitative gamma scintigraphy investigation by Snibson and associates27 revealed shorter residence times for sodium hyaluronate solutions in normal eyes than in patients with dry eye. We agree with Snibson and coworkers that reflex and basal lacrimation has a dilutional effect in normal eyes and that this is decreased in dry eye. In line with this, we observed increases in the percentages of nuclear material retained in both dry-eye groups. After the punctal plugs were inserted, the percentages of retention rose to more than twice the pre-insertion values. To summarize, in this study we used quantitative lacrimal scintigraphy to assess the value of two types of punctal plugs for treating dry eye. Both the collagen and silicone plugs increased aqueous tear volume and thus resulted in objective recovery in all cases. Quantitative measurements of nuclear material in the eye demonstrated prolonged retention of natural tears on the ocular surface after plug insertion. The efficacy of the two types of plugs was similar in short-term follow-up. To our knowledge, this is the first study that has used lacrimal scintigraphy to assess quantitatively the efficacy of punctal plug. These results suggest that dynamic lacrimal scintigraphy is a valid method for evaluating tear dynamics and that it may also be valuable for assessing tear clearance. This topic requires further research with larger numbers of patients. Also, outcomes with collagen versus silicone plugs must be compared over the long-term to investigate dissolution and functional time.
occlusion with silicone plugs and documented improvement in subjective and objective symptoms 6 weeks after insertion. Applying the same stain-grading system13 that we used in our study, they found a decrease in rose bengal staining scores and an increase in TBUT. The authors concluded that punctal plug occlusion in dry-eye cases improves tear film stability and ocular surface staining scores. In our study, we observed statistically significant improvements in rose bengal staining scores and TBUT results for both the collagen-plug and the silicone-plug patient groups. In the collagen group, the mean staining score dropped from 6.63 ⫾ 0.84 pre-insertion to 1.90 ⫾ 0.81 at 3 days post-insertion, and mean TBUT increased from 5.50 ⫾ 1.25 seconds to 12.20 ⫾ 2.50 seconds. In the silicone group, the mean staining score fell from 6.61 ⫾ 0.89 pre-insertion to 2.07 ⫾ 0.79 at the day 3, and mean TBUT increased from 5.42 ⫾ 1.42 seconds to 12.40 ⫾ 2.50 seconds. We also recorded statistically significant improvements in Schirmer I values after insertion of both types of punctal plugs. In line with this, Balaram and associates12 reported increased Schirmer I values and reduced ocular staining with fluorescein and rose bengal stain in dry eye patients at 6 months after insertion of silicone plugs. The same report indicated that the patients were more comfortable and had less need for lubricating drops. The fluorescein clearance test is one way to investigate the ocular surface dynamically.26 Findings of decreased tear secretion and slow fluorescein clearance are compatible with disease of the corneal epithelium. Yen and coworkers14 used this test to study the effects of temporary punctal occlusion with silicone plugs on tear production, tear clearance, and ocular surface sensation in normal subjects. They found a significant decrease in tear fluorescein clearance from day 0 to day 3 in the occluded eyes and concluded this was likely from lacrimal outflow obstruction with the plugs. The lacrimal scintigraphy technique we used to observe dynamically tear accumulation on the ocular surface is similar to the fluorescein clearance test in terms of quantitative measurement. In our collagen group, the mean T1/2 value before insertion was 14.50 ⫾ 6.24 minutes, and this was extended to 24.50 ⫾ 8.00 minutes after insertion. In the silicone-plug group, the mean pre-insertion and postinsertion T1/2 results were 15.64 ⫾ 6.30 minutes and 24.43 ⫾ 7.66 minutes, respectively. The increase in both groups was statistically significant (P ⬍ .001). The mean T1/2 value in the control group (subjects with no ocular surface disorders) was 4.22 ⫾ 1.26 minutes, which was statistically significantly shorter than both the pre-insertion and post-insertion T1/2 values in the two dry-eye groups. We found that, with the occlusion of the lower punta, neither plug type blocked tear outflow completely, but both types prolonged the tear contact time on the ocular surface. Prolonged retention of nuclear material on the ocular surface (longer T1/2) is a quantitative reflection of 88.e5
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REFERENCES 1. Lemp MA. Evaluation and differential diagnosis of keratoconjunctivitis sicca. J Rheumatol Suppl 2000;61:11–14. 2. Calogne M. The treatment of dry eye. Surv Ophthalmol 2001;45(suppl 2):S227–S239. 3. Kurihashi K. Moisture aid during sleep for the treatment of dry eye: wet gauze eye mask. Ophthalmologica 1994;208:216 –219. 4. Cohen EJ. Punctal occlusion. Arch Ophthalmol 1999;117: 389 –390. 5. Rossomondo RM, Carlton WH, Trueblood JH, Thomas RP. A new method of evaluating lacrimal drainage. Arch Ophthalmol 1972;88:523–525. 6. Amanat LA, Hilditch TE, Kwok CS. Lacrimal scintigraphy. III. Physiological aspects of lacrimal drainage. Br J Ophthalmol 1983;67:729 –732. 7. Hanna IT, MacEwen CJ, Kennedy N. Lacrimal scintigraphy in the diagnosis of epiphora. Nuc Med Comm 1992;13:416 – 420. OF
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8. Zilelioglu G, Kucuk O, Tekeli O, Gunan F, Aras G. Quantitative lacrimal scintigraphy after dacryocystorhinostomy. Ophthalmic Surg Lasers Imaging 2004;35:37– 40. 9. Rose JD, Clayton CB. Scintigraphy and contrast radiography for epiphora. Br J Radiol 1985;58:1183–1186. 10. Sousa PC, Pinto P, Leite E, Cunha-Vaz JG. Morphological and/or functional imagiology diagnosis of epiphora. Doc Ophthalmol 1993;83:337–348. 11. Sorensen T, Jensen FT. Lacrimal pathology evaluated by dynamic scintigraphy. Acta Ophthalmol (Copenh) 1980;58: 597– 607. 12. Balaram M, Schaumberg DA, Dana MR. Efficacy and tolerability outcomes after punctal occlusion with silicone plugs in dry eye syndrome. Am J Ophthalmol 2001;131:30 –36. 13. van Bijsterveld OP. Diagnostic tests in sicca syndrome. Arch Ophthalmol 1969;82:10 –14. 14. Yen MT, Pflugfelder SC, Feuer WJ. The effect of punctal occlusion on tear production, tear clearance, and ocular surface sensation in normal subjects. Am J Ophthalmol 2001;131:314 –323. 15. Tai MC, Cosar CB, Cohen EJ, Rapuano CJ, Laibson PR. The clinical efficacy of silicone punctal plug therapy. Cornea 2002;21:135–139. 16. Freeman JM. The punctum plug: evaluation of a new treatment of dry eye. Trans Am Acad Ophthalmol Otolaryngol 1975;79:874 – 879. 17. Glatt HJ. Failure of collagen plugs to predict epiphora after permanent punctal occlusion. Ophthalmic Surg 1992;23: 292–293. 18. Rumelt S, Remulla H, Rubin PA. Silicone punctal plug migration resulting in dacryocystitis and canaliculitis. Cornea 1997;16:377–379.
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19. Soparkar CN, Patrinely JR, Hunts J, Linberg JV, Kertsen RC, Anderson R. The perils of permanent punctal plugs. Am J Ophthalmol 1997;123:120 –121. 20. Akova YA, Demirhan B, Cakmakci S, Aydin P. Pyogenic granuloma: a rare complication of silicone punctal plugs. Ophthalmic Surg Lasers 1999;30:584 –585. 21. White WL, Glover AT, Buckner AB. Effect of blinking on tear elimination as evaluated by dacryoscintigraphy. Ophthalmology 1991;98:367–369. 22. Willis RM, Folberg R, Krachmer JH, Holland EJ. The treatment of aqueous-deficient dry eye with removable punctal plugs. A clinical impression-cytologic study. Ophthalmology 1987;94:514 –518. 23. Guzey M, Ozardali I, Kilic A, et al. The treatment of trachomatous dry eye with canalicular silicone plugs. Eye 2001;15:297–303. 24. Sakamato A, Kitagawa K, Tatami A. Efficacy and retention rate of two types of silicone punctal plugs in patients with and without Sjögren syndrome. Cornea 2004;23: 249 –254. 25. Dursun D, Ertan A, Bilezikci B, Akova YA, Pelit A. Ocular surface changes in keratoconjunctivitis sicca with silicone plug occlusion. Curr Eye Res 2003;26:263–269. 26. Macri A, Pflugfelder SC. Correlation of the Schirmer 1 and fluorescein clearance test with the severity of corneal epithelial and eyelid disease. Arch Ophthalmol 2000;118:1632– 1638. 27. Snibson GR, Greaves JL, Soper NDW, Prydal JI, Wilson CG, Bron AJ. Precorneal residence times of sodium hyaluronate solutions studied by quantitative gamma scintigraphy. Eye 1990;4:594 – 602.
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Biosketch Rana Altan-Yaycioglu, MD, received her medical degree in 1995 and completed her ophthalmology residency in 1999 at the Istanbul Faculty of Medicine. Dr. Altan-Yaycioglu’s research experience includes positions as First A. Edward Maumenee Fellow at the Cornea and External Disease Department of Wilmer Eye Institute, Johns Hopkins School of Medicine, Baltimore, MD (2000), and Research Fellow at Ophthalmic Plastic & Reconstructive Surgeons, Detroit, MI (2001). Dr. Altan-Yaycioglu is currently Assistant Professor in Ophthalmology at Baskent University Faculty of Medicine, Turkey. Primary research interests include ocular surface, eyelid, and lacrimal system disorders.
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● PURPOSE:
To compare the short-term efficacy of collagen and silicone plugs for treating dry eye using quantitative lacrimal scintigraphy. ● DESIGN: Prospective randomized clinical trial. ● METHODS: In this institutional study, 24 dry eye patients were evaluated in two groups: group I (n ⴝ 22 eyes) received collagen plugs and group II (n ⴝ 26 eyes) received silicone plugs. Comparisons were made with normal control subjects (n ⴝ 22 eyes). Data for the Schirmer I test, tear break-up time, and ocular surface staining with rose bengal dye were recorded before and after punctal occlusion. Lacrimal scintigraphy was performed at each time point, and the time to half maximum activity on the ocular surface (T1/2), and the percentage retention of activity on the ocular surface at the end of the dynamic study (RI) were recorded. ● RESULTS: In both patient groups, Schirmer I results, tear break-up times, and rose bengal staining scores improved significantly after plug insertion. Mean T1/2 values and RI values increased significantly in both groups (P < .0001 for both). The differences for these values between groups I and II was statistically insignificant (P > .05). ● CONCLUSIONS: Collagen and silicone plugs both resulted in significant increases in aqueous tear volume, half-life of nuclear material on the ocular surface, and percentage of nuclear material retention. The groups’ post-insertion values for all parameters were similar. These results suggest that these two plug types have similar efficacy as treatments for dry eye in the short term. Further studies evaluating Accepted for publication Feb 11, 2005. From the Department of Ophthalmology (R.A.-Y.), Adana Teaching and Medical Research Center, Baskent University Faculty of Medicine, Adana, and Departments of Nuclear Medicine (E.A.G.) and Ophthalmology (Y.A.A., D.D., F.C., A.A.), Baskent University Faculty of Medicine, Ankara, Turkey. Inquiries to Yonca A. Akova, MD, Baskent University Faculty of Medicine, Department of Ophthalmology, Fevzi Cakmak Cad, 10. Sok, No: 45, 06490, Bahcelievler, Ankara, Turkey; fax: (⫹90) 312-223-7333; e-mail: [email protected]
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long-term results are required. (Am J Ophthalmol 2005; 140:88 –93. © 2005 by Elsevier Inc. All rights reserved.)
D
RY EYE SYNDROME, OR KERATOCONJUNCTIVITIS
sicca, develops as a result of deficient tear secretion or increased evaporation of tears and involves damage to the ocular surface and considerable discomfort.1 When treating dry eye, the aim is to reduce pain, restore a smooth ocular corneal surface, protect the cornea from further damage, and keep tears on the ocular surface longer. Artificial tear solutions are the most widely used therapy for dry eye syndrome. Topical corticosteroids, mast cell stabilizers, and anti-histaminics are used to treat underlying or accompanying disorders.2 Use of soft contact lenses, insertion of plugs in the lacrimal puncta (punctal plugs), and humidifier face masks are some of the other options.2,3 However, prolonged use of contact lenses can actually cause dry eye, and use of contacts in the setting of dry eye may increase the risk of corneal infection. Punctal plug treatment is indicated for dry-eye patients who are using artificial tears but still have complaints and for those who cannot instill eyedrops frequently enough.4 The plugs are made of absorbable material (collagen, gelatin, catgut, or hydroxypropyl methyl-cellulose) or non-absorbable material (silicone, polymethylmethacrylate, polyethylene, and N-butyl cyanoacrylate). There are various designs and models of punctal plugs, and most are excellent for treating dry eye. Absorbable plugs are used before attempting permanent occlusion to observe whether the patient will be able to tolerate the epiphora. Conversely, non-absorbable plugs are used when permanent occlusion of the punctae is needed.2 Rossomondo and coworkers5 introduced lacrimal scintigraphy in 1972. This technique is a simple, non-invasive way to evaluate the lacrimal system. It is most often used to assess the physiologic function of the lacrimal system when investigating epiphora and to evaluate the success of dacryocystorhinostomy.6 – 8 With lacrimal scintigraphy, it is possible to assess the dynamics of lacrimal drainage, the
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permeability fraction of the nasolacrimal canal, tear clearance time, and changes in the percentage of interpalpebral nuclear material activity over time.9 –10 In addition, use of computer-assisted gamma cameras with this technique enables the examiner to generate quantitative outflow curves that illustrate tear drainage over time and also to analyze partial obstruction of the nasolacrimal system.11 In this study, we used lacrimal scintigraphy to compare two types of punctal plugs with respect to their effects on tear volume and ocular surface tear retention time. We put collagen and silicone punctal plugs, as absorbable and non-absorbable plugs that we routinely use in our clinical practice, and evaluated the short-term effects of these plugs.
PATIENTS AND METHODS THIS PROSPECTIVE RANDOMIZED CLINICAL TRIAL WAS
conducted in accordance with the Declaration of Helsinki. Local ethics committee approval was obtained. Each patient was informed about the nature and use of punctal plugs and about the process of lacrimal scintigraphy. All subjects gave written informed consent to participate. The study was conducted in the Ophthalmology and Nuclear Medicine Departments of Baskent University. ● PATIENT POPULATION: Included in the study were 24 consecutive patients (21 women and three men; 48 eyes total) who had been diagnosed with aqueous tear deficiency. All had been using artificial tears, and none had shown subjective or objective improvement in dry eye with these medications. None of the patients had eyelid or blinking problems (that is, evaporative dry eye), and none had previously undergone punctal plug insertion or nuclear scintigraphy. The 24 patients were randomized into two groups. Patients in group I (n ⫽ 11; nine women, two men; 22 eyes) had a collagen plug inserted in the lower punctum of each eye, and patients in group II (n ⫽ 13; 12 women, one man; 26 eyes) had silicone plugs inserted in both lower puncta. Because the lower punctum is usually larger than the upper and drains a greater amount of tears,12 plugs were placed only in the lower punctum. Eleven age- and gender-matched control subjects with no ocular disorders (group III; nine women, two men; 22 eyes) also underwent tear testing and lacrimal scintigraphy for comparison with the patient groups. Mean age (⫾ SD) of groups I, II, and III were statistically similar, at 65.09 ⫾ 11.64 years, 63.69 ⫾ 13.24 years, and 68.63 ⫾ 2.80 years, respectively (P ⬎ .05). ● STUDY PROCEDURE:
Aqueous tear production was assessed with the Schirmer I test. Topical anesthetic was applied, a Whitman filter paper (Alcon Laboratories, Fort Worth, Texas) was placed in the lower conjunctival sac,
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and the measurement at 5 minutes was recorded. Tear film stability was estimated based on tear break-up time (TBUT). A fluorescein-impregnated strip wetted with non-preservative saline solution was placed in the lower conjunctival sac. After one blink, the time to appearance of the first non-stained spot in the stained tear film was recorded. Ocular surface staining was performed only in the patient eyes (groups I and II). This testing was done using a rose bengal strip (Barnes-Hind, Akorn, Abita Springs, Louisiana) and was carried out before and 3 days after the collagen or silicone plugs were inserted. Ocular surface staining was assessed using a rose bengal grading system developed by van Bijsterveld,13 and each eye was scored separately. Nasal bulbar conjunctival staining, temporal bulbar conjunctival staining, and corneal staining were each graded on a four-tier scale: 0 ⫽ no staining, 1 ⫽ mild staining, 2 ⫽ moderate staining, and 3 ⫽ extensive staining. A total staining score greater than 3 of 9 was accepted as keratoconjunctivitis sicca. All 35 subjects underwent lacrimal scintigraphy, and the same nuclear medicine specialist (E.A.G.), who was masked to the patients’ groups, evaluated each set of images. The images were quantitatively analyzed according to activity transition and radioactive field calculations made with a computer-based program. A dual-headed gamma camera (Siemens e.cam, Erlangen, Germany) was used. For each scan, 200 Ci of technetium-99m pertechnetate in 20 l isotonic saline was applied to the ocular surface by micropipette. The subjects were asked to continue normal blinking while the images were taken. Immediately after the radioactive tracer was applied, a dynamic sequence of images was obtained at 30-second intervals for 30 minutes in a 64 ⫻ 64 matrix. Subjects in group III (control subjects) underwent scintigraphy only once. Those in groups I and II had two series of images taken: an initial set before punctal plug insertion, and a second set 3 days after the plugs were in place. In each scintigraphy session, we recorded the time required for half of the nuclear material (99Tc), as measured by the gamma camera, to be cleared from the ocular surface (T1/2). In the patient groups, the percentage of activity that remained on the ocular surface at the end of the dynamic study (RI) was calculated. When the procedure was complete, the eye was rinsed with saline, and antibiotic drops were applied. As noted, collagen or silicone plugs were inserted in the lower puncta of the 48 patient eyes. Before placing each plug, one drop of topical anesthetic (proparacaine hydrochloride 0.5%, Alcon, Puurs, Belgium) was applied to the site. The collagen plugs were made of cow collagen (Lacrimedics, Eastsound, Washington), and the largest size that would fit in the punctum was chosen. Punctum size was measured using a punctal probe. The diameters of the collagen plugs used were 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, and 0.6 mm, and all were 1.75 mm in length. Similarly, the patients who received silicone punctal plugs
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FIGURE 1. The mean Schirmer I values before and after insertion of punctal plugs in the patient groups. Group I ⴝ eyes with collagen plugs inserted; group II ⴝ eyes with silicone plugs inserted.
FIGURE 3. The rose bengal scores before and after insertion of punctal plugs in the patient groups. Group I ⴝ eyes with collagen plugs inserted; group II ⴝ eyes with silicone plugs inserted.
FIGURE 2. The tear film breakup time (TBUT) for before and after insertion of punctal plugs in the patient groups. Group I ⴝ eyes with collagen plugs inserted; group II ⴝ eyes with silicone plugs inserted.
FIGURE 4. The mean time to half maximum activity (T1/2) value for the control group and the mean T1/2 values for before and after insertion of punctal plugs in the patient groups. Group I ⴝ eyes with collagen plugs inserted; group II ⴝ eyes with silicone plugs inserted.
(Odyssey-Parasol Punctal Occluder A14 to 203, Memphis, Tennesee) had the largest size possible inserted. Small (0.35 to 0.65 mm), medium (0.60 to 0.85 mm), and large (⬎0.90 mm) silicone plugs were inserted.
After plug insertion, the mean Schirmer I value in group I increased to 5.77 ⫾ 0.75 mm, and that for group II increased to 5.96 ⫾ 0.87 mm. The rise observed in each patient group was statistically significant (P ⬍ .0001 for both), but the group I and II Schirmer I values after insertion were similar (P ⬎ .05). The mean TBUT findings before plug insertion in groups I and II were similar (Figure 2), at 5.50 ⫾ 1.25 and 5.42 ⫾ 1.42 seconds, respectively (P ⬎ .05). The mean TBUT in the control group was 14.2 ⫾ 3.50 seconds, which was statistically significantly longer than the mean TBUT in both patient groups (P ⬍ .05 for both). After plug insertion, TBUT increased to 12.20 ⫾ 2.50 seconds in group I, and to 12.40 ⫾ 2.50 seconds in group II. Both these increases were statistically significant (P ⬍ .0001 for both), but there was no difference between the groups I and II TBUT findings after insertion (P ⬎ .05). For rose bengal staining of the ocular surface, before plug insertion the mean staining scores in groups I and II were 6.63 ⫾ 0.84 and 6.61 ⫾ 0.89, respectively (P ⬎ .05) (Figure 3). Three days after plug insertion, the scores had dropped to 1.90 ⫾ 0.81 and 2.07 ⫾ 0.79, respectively.
● STATISTICAL ANALYSIS:
Data were statistically analyzed using the program SPSS 11.5 for Windows. Group results were compared using the Student’s t test and one-way analysis of variance (ANOVA). As the post hoc test, Tukey HSD (honestly significantly difference) Method was used. The Wilcoxon signed-rank test was used to compare the results for ocular surface staining with Rose Bengal stain, the Schirmer I values, and the TBUT findings before and after punctal plug insertion.
RESULTS NONE OF THE PATIENTS DEVELOPED ADVERSE EVENTS RE-
lated to the procedure. Before plug insertion, the mean Schirmer I values in groups I (collagen plugs) and II (silicone plugs) were 1.35 ⫾ 0.49 mm and 1.38 ⫾ 0.49 mm, respectively, and the mean in group III (control subjects) was 12 ⫾ 2.06 mm (Figure 1). The pre-insertion Schirmer I values in the patient groups were similar; however, both these means were statistically significantly lower than the mean in group III (P ⬍ .0001 for both). 88.e3
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FIGURE 5. The mean percentages of nuclear material retained at the completion of the scintigraphy for the control group, and for before and after insertion of punctal plugs in the patient groups. Group I ⴝ eyes with collagen plugs inserted; group II ⴝ eyes with silicone plugs inserted; group III ⴝ control eyes.
Both these decreases within groups were statistically significant (P ⬍ .0001 for both). However, the groups’ scores at this stage (recovery) were statistically similar (P ⬎ .05). The T1/2 results for the three groups are shown in Figure 4. Before plug insertion, the mean T1/2 values for groups I and II were similar, at 14.50 ⫾ 6.24 minutes and 15.64 ⫾ 6.30 minutes, respectively (P ⬎ .05). The mean in group III was 4.22 ⫾ 1.26 minutes, and this was statistically significantly shorter than both the patient groups’ preinsertion values (P ⬍ .0001 for both). After plug insertion, the mean T1/2 values in groups I and II increased to 24.50 ⫾ 8.00 minutes and 24.43 ⫾ 7.66 minutes, respectively. Both these increases were statistically significant (P ⬍ .0001 for both). Comparison of the changes in the group T1/2 values from before to after plug insertion between the two groups revealed no statistically significant difference (P ⬎ .05). Before plug insertion, the findings for mean RI in groups I and II were 45.35 ⫾ 19.39% and 44.50 ⫾ 16.75%, respectively (P ⬎ .05; Figure 5). The corresponding result for the control group was 14.27 ⫾ 2.67%, which was statistically significantly lower than the percentages in both patient groups (P ⬍ .0001 for both). After plug insertion, mean RI in groups I and II rose to 68.64 ⫾ 12.77% and 62.12 ⫾ 17.86%, respectively. Both these increases were statistically significant (P ⬍ .0001 for both), but comparison of the changes in group RI values from before and after plug insertion revealed no statistically significant difference (P ⬎ .05).
DISCUSSION PUNCTAL OCCLUSION HELPS PATIENTS RETAIN BOTH NAT-
ural and artificial tears on the ocular surface. Blocking the lacrimal punctum impedes the outflow of tears, thereby increasing the aqueous tear component and keeping natVOL. 140, NO. 1
ural tears on the ocular surface.14 This occlusion can be achieved with various surgical, thermal, and tamponade methods.2,15 Although surgery is rarely used, punctum patching with conjunctival tissue is the most common surgical technique for this purpose because it is reversible. Thermal methods involve occluding the punctum by damaging and shrinking the canalicular walls by laser, cautery, or diathermy. In tamponade techniques, a foreign body is inserted to block the drainage system. This is the most popular method for achieving punctal occlusion because no surgery is required and the results are reversible. Freeman16 was the first to use punctal plugs to treat dry eye. Plugs made of collagen have the advantage of easy insertion and relatively rapid spontaneous dissolution (within approximately 2 weeks); however, these plugs do not provide total occlusion or long-term cure.17 In contrast, silicone plugs may remain intact for 6 months or more and are easy to remove when desired.4 The issue with this type of plug is that long-term exposure to the foreignbody material can result in irritation-related complications.18 –20 The lower punctum often plays a greater role in tear drainage.12 Thus, we put the punctal plugs only on the lower puncta to observe the role of the lower punctal occlusion. In this study, we quantitatively evaluated and compared the efficacy of collagen and silicone punctal plugs using lacrimal scintigraphy. Because collagen plugs dissolve in a short time, we preferred to perform the scintigraphy at day 3, before the dissolving of the collagen, and aimed to investigate the effects in the short term. The data indicate that these two types of plugs yield similar results in the short term. White and associates assessed 17 lacrimal systems of 12 normal subjects and showed that blinking affects tear elimination.21 Using lacrimal scintigraphy, they demonstrated that simple eyelid closure for 2 minutes significantly slowed tear drainage. Because the aim of our study was to evaluate the efficacy of punctal plugs for treating , we excluded subjects with blink disorders or evaporative dry eye. We also instructed all subjects to continue normal blinking during the scintigraphy procedure to prevent any disruption of nuclear material drainage related to lid closure or rapid blinking. A control group was included in the study to observe the clinical significance of lacrimal scintigraphy and investigate the correlation of scintigraphy with the objective examinations such as Schirmer and TBUT. Previous investigations of punctal plug use have demonstrated increased aqueous tear component, increased goblet cell density, improved rose bengal and fluorescein ocular staining, and decreased tear osmolarity.22,23 Sakamato and associates24 studied the efficacy of silicone punctal plugs in dry-eye patients with and without Sjögren syndrome. After the plugs were inserted, the Sjögren group showed greater improvement in rose bengal staining scores than the non-Sjögren group. Dursun and associates25 studied 18 patients with dry eye who underwent punctal
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decreased tear drainage. Compared with the control group, we found that the patients with dry eye had longer T1/2 values and higher percentages of nuclear material retention. The quantitative gamma scintigraphy investigation by Snibson and associates27 revealed shorter residence times for sodium hyaluronate solutions in normal eyes than in patients with dry eye. We agree with Snibson and coworkers that reflex and basal lacrimation has a dilutional effect in normal eyes and that this is decreased in dry eye. In line with this, we observed increases in the percentages of nuclear material retained in both dry-eye groups. After the punctal plugs were inserted, the percentages of retention rose to more than twice the pre-insertion values. To summarize, in this study we used quantitative lacrimal scintigraphy to assess the value of two types of punctal plugs for treating dry eye. Both the collagen and silicone plugs increased aqueous tear volume and thus resulted in objective recovery in all cases. Quantitative measurements of nuclear material in the eye demonstrated prolonged retention of natural tears on the ocular surface after plug insertion. The efficacy of the two types of plugs was similar in short-term follow-up. To our knowledge, this is the first study that has used lacrimal scintigraphy to assess quantitatively the efficacy of punctal plug. These results suggest that dynamic lacrimal scintigraphy is a valid method for evaluating tear dynamics and that it may also be valuable for assessing tear clearance. This topic requires further research with larger numbers of patients. Also, outcomes with collagen versus silicone plugs must be compared over the long-term to investigate dissolution and functional time.
occlusion with silicone plugs and documented improvement in subjective and objective symptoms 6 weeks after insertion. Applying the same stain-grading system13 that we used in our study, they found a decrease in rose bengal staining scores and an increase in TBUT. The authors concluded that punctal plug occlusion in dry-eye cases improves tear film stability and ocular surface staining scores. In our study, we observed statistically significant improvements in rose bengal staining scores and TBUT results for both the collagen-plug and the silicone-plug patient groups. In the collagen group, the mean staining score dropped from 6.63 ⫾ 0.84 pre-insertion to 1.90 ⫾ 0.81 at 3 days post-insertion, and mean TBUT increased from 5.50 ⫾ 1.25 seconds to 12.20 ⫾ 2.50 seconds. In the silicone group, the mean staining score fell from 6.61 ⫾ 0.89 pre-insertion to 2.07 ⫾ 0.79 at the day 3, and mean TBUT increased from 5.42 ⫾ 1.42 seconds to 12.40 ⫾ 2.50 seconds. We also recorded statistically significant improvements in Schirmer I values after insertion of both types of punctal plugs. In line with this, Balaram and associates12 reported increased Schirmer I values and reduced ocular staining with fluorescein and rose bengal stain in dry eye patients at 6 months after insertion of silicone plugs. The same report indicated that the patients were more comfortable and had less need for lubricating drops. The fluorescein clearance test is one way to investigate the ocular surface dynamically.26 Findings of decreased tear secretion and slow fluorescein clearance are compatible with disease of the corneal epithelium. Yen and coworkers14 used this test to study the effects of temporary punctal occlusion with silicone plugs on tear production, tear clearance, and ocular surface sensation in normal subjects. They found a significant decrease in tear fluorescein clearance from day 0 to day 3 in the occluded eyes and concluded this was likely from lacrimal outflow obstruction with the plugs. The lacrimal scintigraphy technique we used to observe dynamically tear accumulation on the ocular surface is similar to the fluorescein clearance test in terms of quantitative measurement. In our collagen group, the mean T1/2 value before insertion was 14.50 ⫾ 6.24 minutes, and this was extended to 24.50 ⫾ 8.00 minutes after insertion. In the silicone-plug group, the mean pre-insertion and postinsertion T1/2 results were 15.64 ⫾ 6.30 minutes and 24.43 ⫾ 7.66 minutes, respectively. The increase in both groups was statistically significant (P ⬍ .001). The mean T1/2 value in the control group (subjects with no ocular surface disorders) was 4.22 ⫾ 1.26 minutes, which was statistically significantly shorter than both the pre-insertion and post-insertion T1/2 values in the two dry-eye groups. We found that, with the occlusion of the lower punta, neither plug type blocked tear outflow completely, but both types prolonged the tear contact time on the ocular surface. Prolonged retention of nuclear material on the ocular surface (longer T1/2) is a quantitative reflection of 88.e5
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REFERENCES 1. Lemp MA. Evaluation and differential diagnosis of keratoconjunctivitis sicca. J Rheumatol Suppl 2000;61:11–14. 2. Calogne M. The treatment of dry eye. Surv Ophthalmol 2001;45(suppl 2):S227–S239. 3. Kurihashi K. Moisture aid during sleep for the treatment of dry eye: wet gauze eye mask. Ophthalmologica 1994;208:216 –219. 4. Cohen EJ. Punctal occlusion. Arch Ophthalmol 1999;117: 389 –390. 5. Rossomondo RM, Carlton WH, Trueblood JH, Thomas RP. A new method of evaluating lacrimal drainage. Arch Ophthalmol 1972;88:523–525. 6. Amanat LA, Hilditch TE, Kwok CS. Lacrimal scintigraphy. III. Physiological aspects of lacrimal drainage. Br J Ophthalmol 1983;67:729 –732. 7. Hanna IT, MacEwen CJ, Kennedy N. Lacrimal scintigraphy in the diagnosis of epiphora. Nuc Med Comm 1992;13:416 – 420. OF
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8. Zilelioglu G, Kucuk O, Tekeli O, Gunan F, Aras G. Quantitative lacrimal scintigraphy after dacryocystorhinostomy. Ophthalmic Surg Lasers Imaging 2004;35:37– 40. 9. Rose JD, Clayton CB. Scintigraphy and contrast radiography for epiphora. Br J Radiol 1985;58:1183–1186. 10. Sousa PC, Pinto P, Leite E, Cunha-Vaz JG. Morphological and/or functional imagiology diagnosis of epiphora. Doc Ophthalmol 1993;83:337–348. 11. Sorensen T, Jensen FT. Lacrimal pathology evaluated by dynamic scintigraphy. Acta Ophthalmol (Copenh) 1980;58: 597– 607. 12. Balaram M, Schaumberg DA, Dana MR. Efficacy and tolerability outcomes after punctal occlusion with silicone plugs in dry eye syndrome. Am J Ophthalmol 2001;131:30 –36. 13. van Bijsterveld OP. Diagnostic tests in sicca syndrome. Arch Ophthalmol 1969;82:10 –14. 14. Yen MT, Pflugfelder SC, Feuer WJ. The effect of punctal occlusion on tear production, tear clearance, and ocular surface sensation in normal subjects. Am J Ophthalmol 2001;131:314 –323. 15. Tai MC, Cosar CB, Cohen EJ, Rapuano CJ, Laibson PR. The clinical efficacy of silicone punctal plug therapy. Cornea 2002;21:135–139. 16. Freeman JM. The punctum plug: evaluation of a new treatment of dry eye. Trans Am Acad Ophthalmol Otolaryngol 1975;79:874 – 879. 17. Glatt HJ. Failure of collagen plugs to predict epiphora after permanent punctal occlusion. Ophthalmic Surg 1992;23: 292–293. 18. Rumelt S, Remulla H, Rubin PA. Silicone punctal plug migration resulting in dacryocystitis and canaliculitis. Cornea 1997;16:377–379.
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19. Soparkar CN, Patrinely JR, Hunts J, Linberg JV, Kertsen RC, Anderson R. The perils of permanent punctal plugs. Am J Ophthalmol 1997;123:120 –121. 20. Akova YA, Demirhan B, Cakmakci S, Aydin P. Pyogenic granuloma: a rare complication of silicone punctal plugs. Ophthalmic Surg Lasers 1999;30:584 –585. 21. White WL, Glover AT, Buckner AB. Effect of blinking on tear elimination as evaluated by dacryoscintigraphy. Ophthalmology 1991;98:367–369. 22. Willis RM, Folberg R, Krachmer JH, Holland EJ. The treatment of aqueous-deficient dry eye with removable punctal plugs. A clinical impression-cytologic study. Ophthalmology 1987;94:514 –518. 23. Guzey M, Ozardali I, Kilic A, et al. The treatment of trachomatous dry eye with canalicular silicone plugs. Eye 2001;15:297–303. 24. Sakamato A, Kitagawa K, Tatami A. Efficacy and retention rate of two types of silicone punctal plugs in patients with and without Sjögren syndrome. Cornea 2004;23: 249 –254. 25. Dursun D, Ertan A, Bilezikci B, Akova YA, Pelit A. Ocular surface changes in keratoconjunctivitis sicca with silicone plug occlusion. Curr Eye Res 2003;26:263–269. 26. Macri A, Pflugfelder SC. Correlation of the Schirmer 1 and fluorescein clearance test with the severity of corneal epithelial and eyelid disease. Arch Ophthalmol 2000;118:1632– 1638. 27. Snibson GR, Greaves JL, Soper NDW, Prydal JI, Wilson CG, Bron AJ. Precorneal residence times of sodium hyaluronate solutions studied by quantitative gamma scintigraphy. Eye 1990;4:594 – 602.
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Biosketch Rana Altan-Yaycioglu, MD, received her medical degree in 1995 and completed her ophthalmology residency in 1999 at the Istanbul Faculty of Medicine. Dr. Altan-Yaycioglu’s research experience includes positions as First A. Edward Maumenee Fellow at the Cornea and External Disease Department of Wilmer Eye Institute, Johns Hopkins School of Medicine, Baltimore, MD (2000), and Research Fellow at Ophthalmic Plastic & Reconstructive Surgeons, Detroit, MI (2001). Dr. Altan-Yaycioglu is currently Assistant Professor in Ophthalmology at Baskent University Faculty of Medicine, Turkey. Primary research interests include ocular surface, eyelid, and lacrimal system disorders.
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