`predominates until the teenage years when the three forms
`have a similar but decreased incidence.
`THIS STUDY WAS SUPPORTED IN PART BY AN UNRE-
`stricted Grant from Research to Prevent Blindness, Inc, New York, New
`York. The authors indicate no financial conflict of interest. Involved in
`design and conduct of study (B.G.M.); collection (B.G.M., A.E.G.);
`management (B.G.M.); analysis and interpretation of the data (B.G.M.,
`N.N.D.); preparation of the manuscript (B.G.M.); and review and
`approval of the manuscript (B.G.M., A.E.G., N.N.D.). Institutional
`Review Board approval was obtained for this study, and only patients who
`provided research authorization were included. Mayo Clinic institutional
`review board approval and HIPAA compliance were appropriately
`followed for this study.
`
`REFERENCES
`
`1. Frandsen AD. Occurrence of squint: a clinical-statistical study
`on the prevalence of squint and associated signs in different
`groups and ages of the Danish population. Acta Ophthalmol
`Suppl 1960;62:9 –157.
`2. Nordlow W. Squint—the frequency of onset at different ages,
`and the incidence of some associated defects in a Swedish
`population. Acta Ophthalmol 1964;42:1015–1037.
`3. Graham PA. Epidemiology of strabismus. Br J Ophthalmol
`1974;58:224 –231.
`4. Friedman MC, Neumann E, Hyams SW, et al. Ophthalmic
`screening of 38,000 children, age 1 to 2 1/2 years, in child
`welfare clinics. J Pediatr Ophthalmol Strabismus 1980;17:
`261–267.
`5. Matsuo T, Matsuo C. The prevalence of strabismus and
`amblyopia in Japanese elementary school children. Ophthal-
`mic Epidemiol 2005;12:31–36.
`6. Yu CB, Fan DS, Wong VW, et al. Changing patterns of
`strabismus: a decade of experience in Hong Kong. Br J
`Ophthalmol 2002;86:854 – 856.
`
`Effect of Prophylactic Brimonidine
`Instillation on Bleeding During
`Strabismus Surgery in Adults
`Samin Hong, Chan Yun Kim, Gong Je Seong, and
`Sueng-Han Han
`
`PURPOSE: To investigate the effects of preoperative bri-
`monidine-purite 0.15% instillation on intraoperative
`bleeding and postoperative subconjunctival hemorrhage
`during strabismus surgery in adult patients.
`DESIGN: Randomized comparative interventional case se-
`ries.
`METHODS: One hundred and eighteen eyes of 90 consec-
`utive adult patients were instilled with either a single
`
`Accepted for publication Apr 17, 2007.
`From the Institute of Vision Research, Department of Ophthalmology,
`Yonsei University College of Medicine, Seoul, Korea.
`Inquiries to Sueng-Han Han, Institute of Vision Research, Department
`of Ophthalmology, Yongdong Severance Hospital, Yonsei University
`College of Medicine, 146-92 Dogok-dong, Kangnam-gu, Seoul, 135-720
`Korea; e-mail: shhan222@yumc.yonsei.ac.kr
`
`drop of brimonidine-purite 0.15% (42 eyes), phenyleph-
`rine 1% (38 eyes), or sodium hyaluronate 0.1% (38
`eyes) 15 minutes prior to strabismus surgery. Intraoper-
`ative bleeding and postoperative subconjunctival hemor-
`rhage were graded on a scale of one to three. The scores
`were compared among the study groups.
`RESULTS: Scores of the intraoperative bleeding and the
`postoperative subconjunctival hemorrhage of the treat-
`ment groups were significantly less than that of the
`control group (P < .001). The scores of the brimonidine
`group were similar to those of the phenylephrine group
`(intraoperative bleeding score, P ⴝ .405; subconjuncti-
`val hemorrhage score, P ⴝ .722).
`CONCLUSIONS: Topical brimonidine administration be-
`fore strabismus surgery may reduce intraoperative bleed-
`ing and postoperative subconjunctival hemorrhage in
`adult patients.
`(Am J Ophthalmol 2007;144:469–470.
`© 2007 by Elsevier Inc. All rights reserved.)
`
`V ASOCONSTRICTING AGENTS SUCH AS PHENYLEPHRINE
`
`have been used prior to strabismus surgery to reduce
`hemorrhage during the procedure. Attack of acute angle-
`closure glaucoma and other systemic complications after
`topical phenylephrine are rare.1 However, these systemic
`adverse reactions include very serious cardiovascular prob-
`lems such as marked hypertension, syncope, myocardial
`infarction, arrhythmia,
`subarachnoid hemorrhage, and
`even death.2,3
`Brimonidine-purite 0.15% is a selective ␣ 2-adrenergic
`agonist that has been widely used to lower intraocular
`pressure in glaucoma patients.4 It is also considered to have
`a vasoconstrictive property. There are some reports that
`the preoperative use of topical brimonidine can help
`reduce bleeding-related problems during laser in situ kera-
`tomileusis (LASIK) and cataract surgery.5,6 We deter-
`mined whether the preoperative use of topical brimonidine
`reduces intraoperative bleeding and postoperative subcon-
`junctival hemorrhage during strabismus surgery in adult
`patients, and compared its effect with the well-known
`strong vasoconstrictor phenylephrine.
`After informed consent from the patients was obtained,
`a total of 118 eyes of 90 consecutive adult patients (49
`males and 41 females) who underwent strabismus surgery
`were included in the study. Mean age was 36.22 ⫾ 14.76
`years. Seventy-four eyes received the extraocular muscle
`recession surgery and 27 eyes received the resection surgery
`(including 11 eyes which received both the recession and
`Ëresection surgery). The patients who received prior ocular
`surgery were excluded.
`A drop of brimonidine-purite 0.15% (42 eyes), phenyl-
`ephrine 1% (38 eyes), or sodium hyaluronate 0.1% (38
`eyes) was applied randomly to the eye(s) of each patient 15
`minutes prior to strabismus surgery. All procedures were
`performed by the same surgeon (S.H.H.). During the
`surgery, the severity of bleeding was detected by the same
`observer (S.H.) in a double-blind manner and classified as
`
`VOL. 144, NO. 3
`
`BRIEF REPORTS
`
`469
`
`Slayback Exhibit 1104, Page 1 of 2
`Slayback v. Eye Therapies - IPR2022-00142
`
`
`
`TABLE 1. Intraoperative Bleeding Scores in Eyes
`Receiving Strabismus Surgery, With and Without
`Prophylactic Brimonidine or Phenylephrine
`
`Treatment Group
`
`Brimonidine 0.15%
`(n ⫽ 42)
`
`Phenylephrine 1%
`(n ⫽ 38)
`
`Sodium Hyaluronate 0.1%
`(n ⫽ 38)
`
`Score
`1
`2
`3
`
`15 (35.71%)
`20 (47.62%)
`7 (16.67%)
`
`19 (50.00%)
`15 (39.47%)
`26 (68.42%)
`
`0 (0.00%)
`12 (31.58%)
`26 (68.42%)
`
`TABLE 2. Postoperative Subconjunctival Hemorrhage
`Scores in Eyes Receiving Strabismus Surgery, With and
`Without Prophylactic Brimonidine or Phenylephrine
`
`Treatment Group
`
`Brimonidine 0.15%
`(n ⫽ 42)
`
`Phenylephrine 1%
`(n ⫽ 38)
`
`Sodium Hyaluronate 0.1%
`(n ⫽ 38)
`
`Score
`1
`2
`3
`
`17 (40.48%)
`18 (42.86%)
`7 (16.67%)
`
`16 (42.11%)
`18 (47.37%)
`4 (10.53%)
`
`0 (0.00%)
`7 (18.42%)
`31 (81.58%)
`
`bleeding-related problems of strabismus procedures with-
`out the risk of serious adverse reactions in adult patients.
`THE AUTHORS INDICATE NO FINANCIAL SUPPORT OR CON-
`flict of interest. All of the authors were involved in the design and
`conduct of study; collection, management, analysis and interpretation of
`the data; and preparation, review or approval of the manuscript. The
`proper informed consent was taken from the participants, and this study
`adherence to Declaration of Helsinki and all federal laws. The ISRCTN
`number is ISRCTN31792393.
`
`REFERENCES
`
`1. Wolfs RC, Grobbee DE, Hofman A, de Jong PT. Risk of acute
`angle-closure glaucoma after diagnostic mydriasis in nonse-
`lected subjects: the Rotterdam Study. Invest Ophthalmol Vis
`Sci 1997;38:2683–2687.
`2. Meyer SM, Fraunfelder FT. 3. Phenylephrine hydrochloride.
`Ophthalmology 1980;87:1177–1180.
`3. Fraunfelder FW, Fraunfelder FT, Jensvold B. Adverse systemic
`effects from pledgets of topical ocular phenylephrine 10%.
`Am J Ophthalmol 2002;134:624 – 625.
`4. Katz LJ. Twelve-month evaluation of brimonidine-purite ver-
`sus brimonidine in patients with glaucoma or ocular hyper-
`tension. J Glaucoma 2002;11:119 –126.
`5. Norden RA. Effect of prophylactic brimonidine on bleeding
`complications and flap adherence after laser in situ keratom-
`ileusis. J Refract Surg 2002;18:468 – 471.
`6. Desco MC, Navea A, Ferrer E, Menezo JL. Effect of prophy-
`lactic brimonidine on bleeding complications after cataract
`surgery. Eur J Ophthalmol 2005;15:228 –232.
`7. Enyedi LB, Freedman SF. Safety and efficacy of brimonidine in
`children with glaucoma. J AAPOS 2001;5:281–284.
`
`FIGURE. Intraoperative bleeding score (Top) and postoper-
`ative subconjunctival hemorrhage score (Bottom) in eyes re-
`ceiving strabismus surgery, with and without prophylactic
`brimonidine or phenylephrine.
`
`follows: grade 1, mild; grade 2, moderate; and grade 3,
`severe. The size of the subconjunctival hemorrhage was
`classified by slit-lamp examination as follows: grade 1, ⬍ 3
`mm; grade 2, between 3 and 5 mm; and grade 3, ⬎5 mm
`after four hours. Statistical analysis was performed using
`the Chi-square test of Pearson and P ⬍.05 was considered
`statistically significant.
`The results are summarized in the Figure and in Tables 1
`and 2. The intraoperative bleeding scores of the treatment
`groups were significantly less than that of the control group
`(P ⬍ .001). However, there was no significant difference
`between the intraoperative bleeding scores of two treat-
`ment groups (P ⫽ .405). Concerning the subconjunctival
`hemorrhage, the scores of the treatment groups were
`significantly less than that of the control group (P ⬍ .001).
`However, no significant difference was noted between the
`postoperative subconjunctival hemorrhage scores of two
`treatment groups (P ⫽ .722). No patient experienced
`angle-closure glaucoma or other systemic complications,
`including cardiovascular problems.
`In conclusion, topical brimonidine administration be-
`fore strabismus surgery reduced intraoperative bleeding and
`postoperative subconjunctival hemorrhage in adult pa-
`tients, and is as effective and as powerful as the well-
`known vasoconstrictor phenylephrine.
`The use of brimonidine is not suitable in pediatric
`patients because it can pass through the blood-brain
`barrier.7 However, its preoperative use can reduce the
`
`470
`
`AMERICAN JOURNAL OF OPHTHALMOLOGY
`
`SEPTEMBER 2007
`
`Slayback Exhibit 1104, Page 2 of 2
`Slayback v. Eye Therapies - IPR2022-00142
`
`