Occlusion of the nonamblyopic eye is highly effective. Optimal compliance for amblyopia therapy: occlusion with a translucent tape on the lens

Transcription

1 Optimal compliance for amblyopia therapy: occlusion with a translucent tape on the lens Raquel G. Beneish,* O(C), MSc; Robert C. Polomeno,* MD, FRCS(C); Michael E. Flanders,* MD, FRCS(C); Robert K. Koenekoop,* MD, PhD, FRCS(C) ABSTRACT RÉSUMÉ Objective: To demonstrate that optimal compliance to amblyopia therapy and a better visual outcome can be achieved by occluding the lens over the preferred eye with a translucent tape. Study Design: Prospective study of amblyopic children. Participants: Eighty-four amblyopic children recruited from 2000 to 2006 at the Montreal Children s Vision Centre. Methods: A group of bilateral ametropes (mean age 3.8 years) were treated with glasses and occlusion of the sound eye with a translucent tape on the lens over the preferred eye, or an adhesive patch. The translucent tape reduced vision to hand motion at 0.3 m in the sound eye. Patients were divided into 2 groups depending on the treatment received. Group 1 (n = 36) was occluded with a translucent tape, and group 2 (n = 48) with a conventional adhesive patch, later replaced by the translucent tape. Twenty-five previously reported patients, treated with the conventional adhesive patch only, were used as controls (group 3). Results: The mean amblyopic visual acuity was 20/ Compliance was good in 36 patients (group 1), and was poor or deteriorated in 24/48 patients (group 2). Substituting the adhesive patch with a translucent tape permitted uninterrupted and prolonged occlusion, with a successful visual outcome. The amblyopic eye achieved a significantly better final vision (20/30+2; groups 1+2) than the controls (20/40+1; group 3) ( p = 0.04). Sixty-four (76.19%) patients achieved 20/30. Conclusions: The translucent tape optimizes compliance and yields better vision by lengthening the duration of occlusion therapy and reducing the number of treatment failures due to noncompliance. Objet : Démontrer qu on peut obtenir l observance optimale du traitement de l amblyopie et un meilleur résultat visuel par l occlusion de la lentille de l œil sain avec un ruban gommé translucide. Nature : Étude prospective de l amblyopie chez les enfants. Participants : Quatre-vingt-quatre enfants amblyopes sélectionnés entre 2000 et 2006 au Centre de la vision de l Hôpital de Montréal pour enfants. Méthodes : Un groupe d enfants avec une amétropie bilatérale (âge moyen, 3,8 ans) ont été soignés avec des lunettes et une occlusion de l œil sain avec un ruban gommé translucide, ou un bandeau adhésif, sur la lentille de l œil préféré. Le ruban adhésif réduit la vision l œil sain au mouvement de la main à 0,3 m. Les patients ont été répartis en 2 groupes selon la nature du traitement. Le 1 er groupe (n = 36) a eu l occlusion avec le ruban gommé translucide, ou un bandeau adhésif et le 2 e groupe (n = 48), avec le bandeau adhésif conventionnel, remplacé par la suite par le ruban translucide. Vingt-cinq autres patients rapportés précédemment, soignés avec le bandeau adhésif conventionnel seulement, ont servi de témoins (3 e groupe). Résultats : La moyenne d acuité visuelle amblyopique était de 20/ L observance a été bonne chez 36 patients (1 er groupe) et pauvre ou s est détériorée chez 24/48 patients (2 e groupe). La substitution de la bande adhésive par un ruban translucide a permis une occlusion prolongée sans interruption et donné un bon résultat visuel. L œil amblyope a obtenu une vision significativement meilleure (20/30+2; 1 er et 2 e groupes) celui des yeux témoins (20/40+1; 3 e groupe) ( p = 0.04). Soixante-quatre patients (76,19 %) ont obtenu 20/30. Conclusions : Le ruban gommé translucide optimise l observance et procure une meilleure vision en allongeant la durée du traitement par occlusion et en réduisant le nombre des échecs du traitement dus au manque d observance. Occlusion of the nonamblyopic eye is highly effective and is the most commonly used method of treatment for functional amblyopia. 1 4 However, the success of treatment, arbitrarily defined in the literature as a visual acuity (VA) 20/40 in the amblyopic eye, depends not only on the condition treated (i.e., anisometropia and (or) strabismus) 1 4 and deprivation amblyopia, 5 7 but also on the compliance with treatment, 8 16 and is reported to range from 35% to 96%. 1 7 In an attempt to improve compliance, the conventional adhesive patch was replaced by a translucent tape on the lens over the preferred eye in children with bilateral high ametropias. 9 This mode of occlusion was subsequently used as the primary treatment in a larger number of children. 10 From *Children s Vision Centre, Montreal Children s Hospital, and Montreal General Hospital, Montreal, Que. Presented in part at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO), in Fort Lauderdale, Fla., May 1998; and in full at the annual meeting of ARVO in Fort Lauderdale, Fla., May Originally received Nov. 21, Revised Mar. 25, 2009 Accepted for publication Apr. 17, 2009 Published online Sep. 16, 2009 Correspondence to Raquel Beneish, O(C), Children s Vision Centre, Montreal Children s Hospital, 2300 Tupper St., Montreal QC H3H 1P3; Raquel.beneish@muhc.mcgill.ca This article has been peer-reviewed. Cet article a été évalué par les pairs. Can J Ophthalmol 2009;44:523 8 doi: /i CAN J OPHTHALMOL VOL. 44, NO. 5,

2 This idea was prompted 19 years ago by a bilateral high hyperope with strabismic amblyopia who would not tolerate anything sticky on her face but who readily accepted occlusion with a translucent tape on the lens. Initially, this study targeted bilateral high ametropes. However, it was attempted successfully in low ametropes not complying with conventional occlusion, and in functional amblyopia associated with an underlying organic component. This study demonstrates the effectiveness of the translucent tape in optimizing compliance to amblyopia therapy and its effect on the duration of treatment and final visual outcome. Methods Newly diagnosed amblyopic children referred to the Montreal Children s Vision Centre were recruited prospectively from 2000 to Eight patients 9 occluded with the translucent tape between 1992 and 1997 and followed beyond 2006 were also included in the study. Eighty-four children with anisometropic and (or) strabismic amblyopia were treated with full spectacle correction, worn 4 to 6 weeks prior to the initiation of occlusion, and full-time or part-time occlusion of the sound eye. Full-time occlusion was defined as occlusion during all waking hours (10 to 14 hours per day depending on the patient s age), and parttime occlusion as occlusion for 2 to 6 hours per day. The nonamblyopic eye was occluded with an adhesive patch on the skin and (or) a translucent tape on the lens. The translucent tape consisted of a single layer of Blenderm (3M, St. Paul, Minn.) initially, which was subsequently substituted by a double layer of Transpore (3M) because it left no glue residue on the lens (Fig. 1). Vision was reduced to hand motion at 0.3 m by the translucent tape. VA was assessed by handheld or projected Allen pictures, Snellen Es, or numbers at 0.3 m and 6 m. Final visual acuities were recorded with Snellen numbers at 6 m and with the Rosenbaum card at 0.3 m. Compliance, defined as the disposition to abide by and follow the prescribed treatment, was judged by the parents account of the actual number of hours patched, and by the patch sign (eyelashes down, different skin colour under adhesive part of the patch) and different tan around the glasses with the translucent tape. The motor alignment was evaluated with the prism and cover test at near and distance fixation. The sensory status was determined with the Worth-4-Dot test and the Titmus stereotest. Success of treatment was defined as a final VA 20/30 in the amblyopic eye, maintained for at least 12 months after cessation of occlusion. Student s t tests were used for statistical analysis of the results. A p value of <0.05 was considered statistically significant. Results The mean age at presentation was 3.8 years ( years). The mean initial VA was 20/100-2 (20/50 to 20/2000) at 6 m and 20/100 (20/40+2 to 20/2000) at 0.3 m in the amblyopic eye, and 20/30-2 (20/20 to 20/50) in the good eye. Two patients with Marfan syndrome had bilateral amblyopia initially, and this accounted for the lower VA range in the good eye. One patient had a visually insignificant anterior polar cataract. Amblyopia was severe in 20/84 patients (mean VA 20/400 [20/250 to 20/2000]), and moderate in 64/84 patients (mean VA 20/100+2 [20/50 to 20/200]) at 6 m and at 0.3 m. The mean initial VA was significantly poorer for the deep amblyopes ( 20/250; n = 20) than for the moderate amblyopes ( 20/200; n = 64) for distance ( p < ) and for near ( p < ) (Fig. 2). The ametropia was moderate to high in both eyes of 74 patients. The refractive error was mild in the sound eye of 8 patients, and in both eyes of 2 patients. Seventy-eight patients were hyperopic with a mean spherical equivalent: of D (+1.25 to +9.00) in the amblyopic eye, and D (+0.25 to +8.50) in the fellow eye. Six patients were myopic, with an average spherical equivalent of D (-1.00 to ) in the amblyopic eye, and D (-0.75 to -9.00) in the fellow eye. Treatment groups and amblyopia types Patients were divided into 2 groups depending on the mode of occlusion they received: group 1, of 36 patients, Fig. 1 Translucent occluder. Fig. 2 Depth of amblyopia versus final vision. 524 CAN J OPHTHALMOL VOL. 44, NO. 5, 2009

3 was occluded with the translucent tape on the lens only, and never received any other treatment; group 2, of 48 patients, was initially occluded with the conventional adhesive patch on the skin, later replaced by the translucent tape on the lens. Twenty-five previously reported 1 patients with a mean age of 5.2 years (3 7 years) treated with the adhesive patch and selected for their high compliance to treatment were included as controls (group 3) for statistical purposes. Amblyopia was anisometropic (spherical equivalent difference D; alignment 4 PD) in 30, strabismic (alignment 7 PD; spherical equivalent difference 1.00 D) in 36 (10 exotropes, 26 esotropes), and combined strabismic and anisometropic (mixed) in 18 patients. Mode and duration of occlusion Fifty-six of 84 patients were treated with full-time occlusion followed by part-time occlusion (group 1, n = 15; group 2, n = 41). Severe amblyopes (VA 20/250) were all treated with full-time occlusion (group 1, n = 4; group 2, n = 16). The mean treatment duration required to achieve the maximum vision was marginally longer statistically ( p = 0.097) for the deep amblyopes (4.03 [SD 2.47] months) than for the moderate amblyopes (3.08 [SD 2.83] months). In other words, severe amblyopia did not preclude a significantly prolonged duration of occlusion. Interestingly, the duration of full-time occlusion was significantly longer in groups 1 and 2 combined (3.55 [SD 2.65] months) than in group 3 (2.3 [SD 1.28] months) Fig. 3 Duration of full-time occlusion. ( p = 0.001) (Fig. 3). Table 1 shows that this difference was attributed to the anisometropes and the mixed amblyopes of groups 1+2 because strabismic amblyopes showed no such difference. The duration of part-time occlusion as maintenance therapy was not significantly different among the types of amblyopia. Twenty-eight of 84 patients were treated with part-time occlusion only: (group 1, n = 21; group 2, n = 7). The duration of part-time occlusion as the primary treatment averaged (SD 12.90) months. The total duration of occlusion averaged (SD 15.73) months for the patients treated with full-time occlusion followed by part-time occlusion, and (SD 12.90) months for those treated with part-time occlusion as the primary treatment. The difference was not statistically significant. Compliance The translucent tape was well tolerated and readily accepted by patients and parents because it involves no skin contact and has a better cosmetic appearance and a low cost. Compliance to occlusion therapy was, and remained, optimal with the tape on the lens over the preferred eye in all 36 patients from group 1. Compliance was initially good in 37/48 patients from group 2 treated with the adhesive patch, and poor in 11/48. Atropine 1% was used in the preferred eye in conjunction with the translucent tape for the first 4 weeks in 4/11 noncompliers. All were high hyperopes, but only 1 had severe amblyopia. Compliance deteriorated in 6 patients after a few weeks of full-time occlusion, and in 7 patients who developed a severe allergic dermatitis requiring the cessation of treatment. The adhesive patch was immediately replaced by the translucent tape in a total of 24/48 patients. Compliance improved to 100%, and vision subsequently to 20/30+2 (20/20 to 20/50). Compliance was, and remained, good in 24/48 patients from group 2, but in view of the success achieved with the noncompliers, the adhesive patch was substituted by the translucent tape after a few weeks of full-time occlusion. Seven older children ( years) attained a mean VA of 20/30 (20/20-2 to 20/50). Two patients with an underlying organic disease (Marfan syndrome), 1 of whom was older, were also successfully treated with the translucent Table 1 Duration of treatment by group and amblyopia type Duration Anisometropes (n = 30) Groups 1+2 (n = 84) Group 3 (n = 25) Strabismics (n = 36) Mixed (n = 18) Anisometropes (n = 6) Strabismics (n = 13) Mixed (n = 6) A Full-time duration * Part-time duration NA NA NA n = 20 n = 23 n = 13 B Part-time duration n = 10 n = 13 n = 5 *p = Significantly longer duration of full-time occlusion for anisometropes between groups 1+2 and 3. p = Significantly longer duration of full-time occlusion for mixed (strabismic anisometropes) between groups 1+2 and 3. Note: A, duration of full-time occlusion in months, followed by part-time occlusion as maintenance therapy; B, duration of part-time occlusion as the primary therapy. No significant difference in length of full-time occlusion for strabismics between groups 1+2 and 3. No significant difference in duration of part-time occlusion as the primary therapy for strabismics and mixed. Duration of part-time occlusion longer for strabismics and for mixed than for anisometropes, but not significantly because of very high variances. CAN J OPHTHALMOL VOL. 44, NO. 5,

4 tape. It is worthwhile to note that 10 low ametropes (sound eye, n = 8; both eyes, n = 2) showed good compliance to occlusion with the translucent tape and achieved a mean VA of 20/25-2 (20/20-2 to 20/40). Unexpectedly, the mean duration of full-time occlusion was significantly longer for the noncompliers (4.00 [SD 2.30] months) than for the compliers (3.00 [SD 2.57] months) ( p = 0.003). However, the duration of part-time occlusion (maintenance therapy) was not (20.33 [SD 10.36] months and [SD 12.71] months), and neither was the final vision they attained (20/30+1 and 20/30+2, respectively). Although children occasionally look over the glasses for distance, they are effectively patched for many hours at near, and once they learn to use their amblyopic eye, compliance becomes optimal, as demonstrated by their visual results: VA 20/25 in 42/84 (50%), VA 20/30 in 64/84 (76.19%), and VA 20/50 in 84/84 (100%). Initial versus final visual acuity The final VA attained by the severe (n = 20) and moderate (n = 36) amblyopes treated with full-time occlusion was not significantly different because both achieved 20/30 in 75% of the patients (mean 20/30+1; p = 0.37). Table 2 confirms this result for all moderate amblyopes (n = 64). In summary, the severity of the amblyopia had no influence on the final VA. Table 3 summarizes the results of treatment by group and by amblyopia type. The improvement ratio (final vision - initial vision / 1 - initial vision), defined as the actual improvement in vision relative to the maximum improvement possible, was also included, to account for the differences in initial VA among patients. A higher ratio signifies a greater improvement relative to the initial vision. The improvement ratios for anisometropic and strabismic amblyopes in groups 1 and 2 did not differ; however, both were significantly higher than those of group 3 ( p values in Table 2), with a significantly better final vision ( p = and p = , respectively). The mixed amblyopes showed a significantly higher improvement ratio ( p = 0.006) and final vision ( p = 0.01) only in group 2 compared with group 3. The mean VA achieved for groups 1+2 was not significantly different for patients treated with full-time occlusion followed by part-time occlusion (20/30+2), compared with those treated with part-time occlusion as the primary treatment (20/25-2) ( p = 0.25). Interestingly, the final vision attained in groups 1+2 (20/30+2 [20/20 to 20/50]) was significantly better than in group 3 (20/40+1 [20/20 to 20/70]) ( p = 0.04) (Fig. 4). Success of treatment The mean final VA at 6 m was 20/30+2 (20/20 to 20/50) in the amblyopic eye, and 20/20-2 (20/20 to 20/40) in the good eye. The mean final near VA in the amblyopic eye was 20/25+1 (20/20 to 20/50). The ocular alignment was 8 PD in 64 patients. Fusion assessed with the Worth-4-Dot test was present in 61/84 and stereopsis assessed with the Titmus test was found in 64/84 with a mean of 190 seconds of arc ( ). The time elapsed after the end of treatment averaged 2.5 years (range 1 13 years). The average follow-up was 4.94 years (range 3 17 years). Conclusions Compliance and duration of occlusion are 2 critical factors influencing the success or failure of amblyopia therapy. Table 2 Final vision in amblyopic eye for severe and moderate amblyopes Final visual acuity Level 20/25 (%) 20/30* (%) 20/40 (%) 20/50 (%) Severe amblyopia 9/20 (45) 6/20 (30) 2/20 (10) 3/20 (15) Moderate amblyopia 33/64 (51.5) 16/64 (25) 10/64 (15.5) 5/64 (8) *Anterior polar cataract. Marfan syndrome (n = 2). Note: Each cell represents the number and percentage of patients who achieved the corresponding visual acuity. Table 3 Visual acuity improvement in the amblyopic eye categorized by type and group Group VA Anisometropes (A), n = 15 Strabismics (S), n = 15 Mixed (M), n = 8 p values by group and type Group 1 Initial VA 20/80 20/ /80-1 A1 A2 ns n = 36 Final VA 20/ / /25-2 A1 A Imp ratio A2 A n = 15 n = 21 n = 10 Group 2 Initial VA 20/125 20/125 20/200 S1 S2 ns n = 48 Final VA 20/ / /25-2 S1 S Imp ratio S2 S n = 7 n = 13 n = 5 Group 3 Initial VA 20/90 20/125 20/125 M1 M2 ns n = 25 Final VA 20/ / /30-2 M1 M3 ns Imp ratio M2 M Note: VA, visual acuity (data shown as mean VA); Imp ratio, ratio of final VA - initial VA / 1 - initial VA (actual improvement in vision relative to the maximum possible improvement to account for the differences in initial VA among patients); A1, A2, A3, anisometropes in groups 1, 2, and 3 (A1 A2, A1 A3, A2 A3 compare the improvement ratio between the 2 designated groups); S1, S2, S3, strabismics in groups 1, 2, and 3 (S1 S2, S1 S3, S2 S3 compare the improvement ratio between the 2 designated groups); M1, M2, M3, mixed (anisometropic and strabismic) in groups 1, 2, and 3 (M1 M2, M1 M3, M2 M3 compare the improvement ratio between the 2 designated groups). ns, not significantly different. 526 CAN J OPHTHALMOL VOL. 44, NO. 5, 2009

5 Electronic monitoring of compliance has demonstrated a statistically significant relationship between the increase in VA and compliance However, in the absence of electronic monitoring, it is possible to confirm a good patch sign. Compliance has been improved successfully with optical 17,18 and pharmacological 18,19 penalization. France and France 17 reported 82% compliance and a better visual outcome with no deterioration, with optical penalization. Foley-Nolan et al. 19 reported a longer treatment duration and a better visual outcome with atropine penalization than with occlusion. Iacobucci et al. 20 reported a high compliance rate (94%) with Bangerter foils in the treatment of moderate amblyopia ( 20/60). Bangerter filters were used at our institution 30 years ago. However, this mode of occlusion was discontinued because of the high cost of the filters. The translucent tape is inexpensive and can be replaced rapidly at any time by the parents or the health professional. Our finding that the severity of amblyopia has no influence on the final visual outcome is in agreement with Levartovsky et al., 21 but differs from Scott et al., 22 who report that they are strongly correlated. This study confirms the Pediatric Eye Disease Investigator Group 23 report that occlusion for 6 hours per day yielded the same visual outcome as full-time occlusion for severe amblyopia, after 4 months of treatment. However, the total duration of treatment in our study (21.13 months) was considerably longer than that reported by Foley-Nolan 19 with conventional occlusion, or by Iacobucci et al. 20 with Bangerter foils (4.3 and 8.1 months, respectively). Furthermore, the duration of occlusion with the translucent tape was significantly longer for the noncompliers than for the compliers. This is clear evidence for the validity of the translucent tape as an occluder and would explain the high success rate achieved in the noncompliers, whose compliance improved to 100% and who attained the same final VA as the compliers. The translucent tape allows for continued treatment and for a better visual outcome when compliance deteriorates. In this study, 24 failures (28.56%) due to poor compliance Fig. 4 Effect of occlusion mode on visual outcome. to treatment with the conventional adhesive patch were prevented by the use of the translucent tape. Our results show that older children respond well to amblyopia therapy, providing good compliance, as previously reported. 8 Also included in this study were 2 patients with Marfan syndrome, to demonstrate that the functional part of the amblyopia with an underlying organic component responds well to treatment; this has been the standard practice at our institution for the past 30 years. However, the major disadvantage of the translucent tape is its restricted use to patients with glasses, preferably with moderate-tohigh refractive errors. Even if a child looks over the glasses for distance, when the vision in the amblyopic eye is very poor, the translucent tape is worn effectively for a large part of the day at near, and once the child becomes accustomed to using the amblyopic eye, compliance becomes optimal. In summary, this study has demonstrated that occlusion with a translucent tape on the lens over the preferred eye provides a successful alternative to amblyopia therapy when treatment with the conventional adhesive patch fails or is no longer tolerated. The translucent tape optimizes compliance and yields a better visual outcome by lengthening the duration of occlusion therapy and by reducing the number of treatment failures due to noncompliance. The authors would like to acknowledge the help of Professor M. Daniel Beneish, PhD, for performing the statistical analysis of the results; Josée Navratil, OC(C), a friend and colleague, for her continuous support; Julie Racine, PhD, for editing the manuscript; and Amer Omar, MD, for his invaluable help in the final revision. The authors have no proprietary or commercial interest in any materials discussed in this article. References 1. Beneish R, Lachapelle P, Polomeno RC, Lake N. Pattern VEP differences in strabismic and anisometropic amblyopia. Clin Vision Sci 1990;5: Beneish R, Williams F, Polomeno RC, Little JM, Connolly WES. Ultrasonography in unilateral high myopia and amblyopia. Trans. Fifth International Orthoptic Congress 1984; Lithander J, Sjöstrand J. Anisometropic and strabismic amblyopia in the age group 2 years and above. A prospective study of the results of treatment. Br J Ophthalmol 1991;75: Flynn JT, Schiffman J, Feuer W, Corona A. 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