ORIGINAL STUDY

Patient Acceptance and Attitude Toward an Alternative Method of Subconjunctival for the Medical Treatment of Glaucoma

Rachel S. Chong, MBBS,* Daniel H.W. Su, FRCSEd,* Andrew Tsai, MBBS,w Yuzhen Jiang, MD, PhD,wz Hla Myint Htoon, PhD,w Ecosse L. Lamoureux, PhD,wy Tin Aung, FRCSEd, PhD,*w8 and Tina T. Wong, FRCSEd, PhD*w8z

and patients. This is compounded when dealing with Purpose: Nonadherence to glaucoma medications may be a major asymptomatic illnesses such as glaucoma, the second most cause of treatment failure. We examined the acceptance of important cause of irreversible blindness in the world. glaucoma patients toward a possible new route of administering Elevated intraocular pressure (IOP) is the only modifiable glaucoma medication by subconjunctival injection. risk factor and IOP-lowering eye drops is the first line Patients and Methods: Patients were recruited from specialist treatment for glaucoma. It has been estimated that the glaucoma clinics on a voluntary basis. Trained interviewers proportion of nonadherers to antiglaucoma medication administered a 30-item questionnaire and an information sheet may be as high as 59%,1 and that deviations from the with details of an alternative subconjunctival injection route prescribed medication regime result in dose omission, or involving injections at 3-month intervals. Outcome measures inappropriate time intervals between doses.2–4 Further- regarding acceptance of the new procedure, social situational more, it has been reported that the proportion of doses factors, disease factors, and treatment factors were assessed. taken in the 24 hours before a scheduled clinic visit was Results: A total of 151 patients participated in this study. Of the significantly higher than over the entire observation 151 patients 112 (74.2%) were willing to have their glaucoma period,5 which implies that IOP measurements taken in medication given by the new method of subconjunctival injection, clinic may not accurately represent a patient’s usual IOP. 101 of 112 (90.2%) were willing to accept it at the same cost as their Efforts have been made to identify potential non- present medication, and 87 of 101 (86.1%) were willing to accept it adherers although a literature review examining 29 separate even at a higher cost. These patients tended to be on a greater number of medications (P = 0.006), and medicating more fre- studies has suggested equivocal relationships between quently in a day (P = 0.003). Nine of 10 (90%) patients who were nonadherence to glaucoma medication with patients’ age, admitted to nonadherence were willing to accept subconjunctival sex, ethnic background, education, knowledge of glaucoma, injections at 3-month intervals in place of their . or the frequency of side effects.6 However, a few studies have observed an association between a dose frequency Conclusions: Our study found that 74% of glaucoma patients were higher than twice a day with nonadherence to glaucoma willing to accept an alternative form of glaucoma treatment through 7–10 3-monthly subconjunctival injections. A large proportion of patients therapy. Electronic event medication monitoring devi- who were admitted to nonadherence to topical medication were ces have also demonstrated poorer adherence with more 11 willing to consider this alternative method of medication. Our complex regimens. findings are helpful when developing patient-acceptable drug- Interventions to enhance adherence that have been delivery regimes, which may alleviate the need for daily medication. tested include memory aids which display dosage informa- tion,12 audible medication alarm devices,13 and tailored Key Words: glaucoma medication, acceptance, subconjunctival education programs14 where patients were assisted in injection identifying suitable times for eye-drop application in their (J Glaucoma 2013;22:190–194) daily routines. Adverse side effects such as burning, stinging, and ocular hyperemia that are associated with glaucoma medications may be a deterrent to adherence, although a study suggests that subjects who acknowledge onadherence to treatment in chronic conditions these events are more likely to be taking their medication.15 remains a challenging problem for both clinicians N Poor administration of an resulting from visual impairment or physical disability has also been found to be Received for publication January 9, 2011; accepted September 12, 2011. a significant barrier to adherence in glaucoma patients, with From the *Singapore National Eye Centre; wSingapore Eye Research 16 Institute; 8Department of Ophthalmology, National University of potential economic and therapeutic implications. Singapore; zSchool of Materials Science and Engineering, Nanyang Given the many challenges faced by patients and Technological University, Singapore, Republic of Singapore; zState clinicians in ensuring patient adherence in the treatment of Key Laboratory of Ophthalmology, Zhongshan Ophthalmic glaucoma and the growing interest in alternative treatment y Centre, Sun Yat-sen University, Guangzhou, China; and Centre methods to minimize patient’s nonadherence, including for Eye Research Australia, University of Melbourne, Royal 17,18 Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia. juxtascleral depot injections, we report on a study that Disclosure: The authors declare no conflict of interest. examined patients’ acceptance and attitudes toward a Reprints: Tina T. Wong, FRCSEd, PhD, Singapore National Eye proposed injectable slow-release drug-delivery system as Centre, 11 Third Hospital Avenue, Singapore 168751, Republic of Singapore (e-mail: [email protected]). an alternative method for delivering glaucoma medication. Copyright r 2013 by Lippincott Williams & Wilkins A better understanding of the beliefs and attitudes profile of DOI:10.1097/IJG.0b013e318237c6c4 these patients may enable the development of a simplified

190 | www.glaucomajournal.com J Glaucoma Volume 22, Number 3, March 2013 J Glaucoma Volume 22, Number 3, March 2013 Patient Acceptance to Alternative Glaucoma Treatment drug regime, which is less reliant on the self-administration CA). Questions asked about patients’ glaucoma medication of topical medication. regime at the time of the study comprised of the following: duration of medication, number of different types of METHODS medication, daily dosage frequency (based on the total number of drops instilled into the eye each day), and the Study Design occurrence of any side effects including burning sensation, This was a hospital-based, cross-sectional study of itch, foreign-body sensation, redness, bitter taste, or blurring patients in the glaucoma department at a public tertiary of vision. The sum total of all side effects was also added up hospital in Singapore. Consecutive patients were recruited for each patient. Patient charts were also reviewed for from specialist glaucoma clinics, and on providing in- previous documentation of medication regimens or side formed consent, volunteered to participate in an inter- effects if patients were unsure of the details. viewer-administered survey. Ethical approval was obtained from the Institutional Review Board of Singapore Eye Research Institute. Data Analysis The association between patients’ responses to ques- Participant Inclusion and Exclusion Criteria tionnaire items and each outcome measure was assessed. Recruitment was based on the following eligibility After testing for normal assumptions of continuous criteria: (1) diagnosed glaucoma on either 1 or more topical dependent variables, an independent t test and Mann- eye drop(s) with no prior history of intraocular or Whitney U tests were applied appropriately. Categorical 2 glaucoma surgery; (2) ability to converse in English or variables were evaluated using w and Fisher exact tests Mandarin; and (3) willingness to complete the question- appropriately for associations with the dependent catego- naire. Glaucoma patients who did not fulfill all of the above rical variables. SPSS version 17 was used for the analyses. were excluded from the study. Measures RESULTS Patients’ general and ocular health and socio-demo- A total of 151 patients comprising 90 (59.6%) men and graphic details were obtained by self-report. Details of the 61 (40.4%) women participated in the study (Table 1). The patients’ ophthalmic conditions were collected from medical patients’ mean ± SD age was 65.25 ± 11.33 years. There records. Patients were administered a 30-item questionnaire were 130 (86.1%) Chinese, 11 (7.28%) Indians, 7 (4.64%) and an information sheet containing details of a subcon- Malays, and 3 (1.99%) Eurasians. Of these 110 (73.9%) had junctival injection as a possible alternative method to receive primary open-angle glaucoma and 39 (26.2%) had primary the antiglaucoma medication by a trained assistant. angle-closure glaucoma. Data for the type of glaucoma were Three outcome measures identifying specific areas of missing for 2 patients. The mean ± SD duration of glaucoma acceptance of this new procedure were assessed: was 46.3 ± 49.8 months. The mean ± SD duration of 1. Willingness to have glaucoma medication administered glaucoma medication usage was 38 ± 44.2 months and a by subconjunctival injection at 3-month intervals mean ± SD value of 1.6 ± 0.8 types of medications was 2. Willingness to accept a novel drug-delivery route if it prescribed. Seven of 151 (4.6%) patients reported need for costs the same as present medication assistance in eye-drop administration. Five (71.4%) patients 3. Willingness to accept a novel drug-delivery route if it attributed this to physical difficulties, 1 (14.3%) to sight costs more than present medication difficulties, and 1 (14.3%) to both. None of these factors had Self-reported adherence to topical glaucoma medica- a significant relationship with any of our outcome measures. tion was also assessed as a single question (item 17) in the Of the 151 patients 112 (74.2%) were willing to have questionnaire. Information collected about the patient’s their glaucoma medication given by the new method of socio-demographic and economic background included the subconjunctival injection every 3 months. Logistic regression following: age, sex, race, education level, employment analyses showed that there was no significant association status, marital status, and family history of glaucoma. between any of the factors examined for example, socio- Patients’ belief about disease outcome, treatment control, demographic and economic background, belief about disease and cost of treatment were also assessed. Socio-situational outcome, treatment control, and cost of treatment, socio- factors addressed in the questionnaire included the follow- situational factors, disease variables, glaucoma medication ing: living arrangements, requiring assistance for treatment regime at the time of the study, and the occurrence of any because of physical or visual impairments. side effects as detailed in the Methods section, and general Disease variables taken from patients’ charts included acceptance of by subconjunctival injection. Of the following: duration of glaucoma, type of glaucoma, the 112 willing patients, 101 (90.2%) would accept this vertical cup-to-disk ratio of affected eyes, best corrected visual alternative method if it costs the same as their present acuity, mean deviation, and pattern standard deviation on the medication. These patients were on a greater number of most recent reliable Humphrey visual field test. Vertical cup- medications (1.7 ± 0.8 bottles compared with 1.3 ± 0.7 to-disk ratio was determined using slit-lamp biomicroscopy bottles P = 0.006) and had a more frequent daily dosing with Volk 78 or 90 D condensing lenses. Visual field tests were regimen (2.6 ± 1.5 times a day compared with 1.9 ± 1.4, conducted with a Humphrey Visual Field Analyzer II (Carl P = 0.001). Of the 101 patients 87 (86.1%) were still willing Zeiss Ophthalmic Systems Inc., Dublin, CA) set for the to have subconjunctival injections in place of their topical central 24-2 threshold test, size III white stimulus, and medication, even if it costs more. These patients also tended Swedish Interactive Threshold Algorithm standard strategy. to be on a greater number of medications (1.7 ± 0.8 bottles Reliability criteria were established as <20% fixation losses, compared with 1.4 ± 0.4 bottles, P = 0.013) and a more <33% false-negative error, and <33% false-positive error, frequent daily dosing regimen (2.6 ± 1.5 times a day as recommended by Humphrey Instruments Inc. (Dublin, compared with 2.0 ± 1.5 times a day, P =0.003). r 2013 Lippincott Williams & Wilkins www.glaucomajournal.com | 191 Chong et al J Glaucoma Volume 22, Number 3, March 2013

medication tended to have a family history of glaucoma [6 TABLE 1. Patient Demographics of 10 (60%), P = 0.004], were using fewer different types of Patient factors N = 151 medication (1 ± 0.8 bottles compared with 1.6 ± 0.7 Age (y) 65.25 ± 11.33 bottles, P = 0.040) and were more likely to be working. Sex N (%) Male 90 (59.6) Female 61 (40.4) Race Chinese 130 (86.1) DISCUSSION Indian 11 (7.28) This cross-sectional study, using glaucoma patients Malay 7 (4.64) receiving treatment at a tertiary hospital in Singapore, Eurasian 3 (1.99) revealed interesting findings related to issues of adherence Education and attitudes toward an alternative route of administering Primary school and below 61 (40.4) glaucoma medication. We showed that the majority of the Secondary school and above 90 (59.6) patients on multiple types of eye drops and frequent daily Employment status dosing regimens were willing to accept a novel glaucoma Unemployed 33 (21.9) treatment through subconjunctival injection. We also found Employed 65 (43.0) Retired 53 (35.1) that almost all patients who reported nonadherence with Marital status their current topical glaucoma medications were willing to Single 12 (7.95) accept this new form of treatment. These patients tended to Married 111 (73.5) be working individuals, on fewer types of medication, and Divorced 5 (3.31) with a positive family history of glaucoma. It is possible Widowed 23 (15.2) that these patients and their relatives may have mild disease Family history of glaucoma with fairly well-controlled IOP and were therefore not No 106 (70.2) aware of the potential sight-threatening nature or severity Yes 26 (17.2) of glaucoma. However, we found no association between Unknown 19 (12.6) Disease factors patient acceptance of subconjunctival injection and any of Duration of glaucoma (mo) 46.3 ± 49.8 the disease variables assessed in our study. Further studies Type of glaucoma using larger sample are needed to investigate other Normal tension glaucoma 46 (30.9) significant associations in this particular subgroup of Primary open-angle glaucoma 64 (43.0) patients. Overall our findings suggest that this new form Primary angle-closure glaucoma 39 (26.2) of drug delivery is a preferred option to glaucoma topical Vertical cup-disc ratio medication. Left eye 0.76 ± 0.2 To the best of our knowledge, this is the first reported Right eye 0.76 ± 0.2 study to examine patient opinion and acceptance of a Mean deviation Left eye 10.8 ± 9.50 subconjunctival injection as an alternative treatment over eye Right eye 10.0 ± 8.52 drops for delivering their IOP-lowering medication. There is Pattern standard deviation no established ocular therapy at present that makes use of Left eye 5.50 ± 3.81 sustained-release subconjunctival injections in place of daily Right eye 6.24 ± 4.02 eye drop administration. Although recent studies suggest Situational factors that juxtascleral depot injection of anecortave acetate results Reliance on assistance to administer eyedrops in significant IOP reduction.19,20 Given these new develop- No 137 (90.7) ments and our results that show the majority of glaucoma Yes 14 (9.27) patients in our population are willing to take up potential Living arrangements Lives alone 14 (9.27) drug therapies involving subconjunctival injections, it is Lives with family 135 (89.4) possible that a well-accepted implantable sustained-release Nursing home resident 2 (1.32) treatment device that circumvents many of the barriers to Reliance on assistance to attend clinic adherence may eventually become a reality. Concurrent No 149 (98.7) studies are required to gain a better understanding of Yes 2 (1.32) patients’ attitudes in the target population, even as further Best corrected visual acuity (LogMAR) research is conducted into drug-delivery systems. Left eye 0.21 ± 0.33 Research into patients’ acceptance of different ocular Right eye 0.2 ± 0.34 drug administration methods is particularly relevant at a Glaucoma medication regime Duration of glaucoma medication (mo) 38.0 ± 44.2 time when subconjunctival injections are becoming more No. of glaucoma medications 1.55 ± 0.76 commonly used by ophthalmologists. Subconjunctival 21 Daily dosing frequency 2.36 ± 1.53 injection of antimetabolites such as mitomycin-C and No. side effects experienced 0.42 ± 1 5-fluorouracil22 is already widely practiced in clinics as a useful adjunct to glaucoma filtration surgery for failing blebs, which do not respond to medical therapy. Intra- A total of 10 (7.1%) patients reported nonadherence vitreal long-acting antivascular endothelial growth factor to medication based on our questionnaire. Nine of these agent bevacizumab (Avastin) has also gained widespread (90%) were willing to accept subconjunctival injections in recognition as an effective treatment for neovascular age- place of their topical medical medication. Seven of these 9 related macular degeneration.23 Our findings may therefore (77.8%) were willing to accept this novel form of treatment serve as a useful starting point in developing patient- even if it costs the same, or more than their present acceptable drug therapies that optimize drug delivery for regimen. Patients who reported nonadherence to their glaucoma patients.

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This study was limited by a small sample size, and 5. Rotchford AP, Murphy KM. Compliance with timolol treat- the fact that it was conducted at a single tertiary referral ment in glaucoma. Eye. 1998;12:234–236. centre with a relatively small geographic catchment area. 6. Olthoff CM, Schouten JS, van de Borne BW, et al. Non- Problems with patient’s access to clinics or pharmacies to compliance with ocular hypotensive treatment in patients with glaucoma or ocular hypertension. Ophthalmology. 2005;112: obtain medications were not addressed in our question- 953–961. naire, although the majority of our patients either lived with 7. Gurwitz JH, Glynn RJ, Monane M, et al. Treatment for their families or under institutionalized care (Table 1) where glaucoma: adherence by the elderly. Am J Public Health. 1993; this is likely to be less of an issue. The test-retest reliability 83:711–716. and validity of our questionnaire were not assessed, in 8. Mackean JM, Elkington AR. Compliance with treatment of comparison with more established patient belief surveys like patients with chronic open-angle glaucoma. Br J Ophthalmol. the Brief Illness Perception Questionnaire. 1983;67:46–49. We acknowledge that our adherence measure was a 9. Patel SC, Spaeth GL. Compliance in patient prescribed self-report and single item rather than an objective measure eyedrops for glaucoma. Ophthalmic Surg. 1995;26:233–236. of when and how patients took their medicines. This is a 10. Konstas AGP, Maskaleris G, Gratsonidis S, et al. Compliance and viewpoint of glaucoma patients in Greece. Eye. 2000;14: limitation of this study as self-report measures are subject to 752–756. social desirability and recall bias, and adherence is likely to 11. Robin AL, Novack GD, Covert DW, et al. Adher- be overestimated. Although the accuracy of self-report ence in glaucoma: objective measurements of once-daily and measures of adherence in glaucoma requires further inves- adjunctive medication use. Am J Ophthalmol. 2007;144: tigation, it can be accurate and provide useful qualitative 533–540. information about adherence as shown in other health 12. Chang JS, Lee DA, Petursson G, et al. The effect of a areas.24,25 Furthermore, although efforts were made to glaucoma medication reminder cap on patient compliance and ensure patient’s understanding and cooperation through a intraocular pressure. J Ocul Pharmacol. 1991;7:117–124. trained interviewer who administered the questionnaire, it is 13. Laster SF, Martin JL, Fleming JB. The effect of a medication alarm device on patient compliance with topical pilocarpine. still possible that some patients did not fully comprehend the J Am Optom Assoc. 1996;67:654–658. concept of subconjunctival injection whereas completing the 14. Sclar DA, Skaer TL, Chin A, et al. Effectiveness of the C Cap questionnaire as health literacy was not formally assessed in in promoting prescription refill compliance among patients our study. 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Reduction of result in negative health outcomes in many chronic illnesses intraocular pressure with anecortave acetate in eyes with requiring lifelong management, including glaucoma.26,27 ocular steroid injection-related glaucoma. Arch Ophthalmol. Lowering of IOP is imperative in limiting optic nerve 2009;127:173–178. damage and visual loss, but research on adherence to 18. Prata TS, Tavares IM, Mello PA, et al. Hypotensive effect of antiglaucoma treatment has revealed that considerable juxtascleral administration of anecortave acetate in different proportions of patient deviate from their recommended types of glaucoma. J Glaucoma. 2010;19:488–492. medication regimen.28,29 Although physicians must monitor 19. Robin AL, Suan EP, Sjaarda RN, et al. Reduction of intraocular pressure with anecortave acetate in eyes with and encourage proper medication use among glaucoma ocular steroid injection-related glaucoma. Arch Ophthalmol. patients, we need to evaluate novel processes to help 2009;127:173–178. patients with this process to improve drug delivery and 20. Prata TS, Tavares IM, Mello PA, et al. Hypotensive effect of treatment outcomes. Our study suggests that glaucoma juxtascleral administration of anecortave acetate in different patients may be interested in the alternative method of types of glaucoma. J Glaucoma. 2010;19:488–492. subconjunctival injection of glaucoma medication that may 21. Iwach AG, Delgado MF, Novack GD, et al. Transconjunctival alleviate the need for daily eye-drop administration. mitomycin-C in needle revisions of failing blebs. Ophthalmol- Successful developments in this direction could significantly ogy. 2003;110:734–742. decrease nonadherence to glaucoma medication and 22. Costa VP, Correa MM, Kara-Jose N. Needling versus medical treatment in encapsulated blebs. A randomized, prospective improve the outcome for patients suffering from this study. 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27. Kass MA. Timolol treatment prevents or delays glaucomatous 11. Have you ever run out of medication before your next visual field loss in individuals with ocular hypertension: a five- clinic visit?: yes/no year, randomized, double-masked, clinical trial. Trans Am 12. Do you think clinic visits are scheduled too frequently?: Ophthalmol Soc. 1989;87:598–618. yes/no 28. Haynes RB, Ackloo E, Sahota N, et al. Interventions for enhancing medicaton adherence. Cochrane Database Syst Rev. 13. Family history of glaucoma: yes/no/unknown 2008;CD000011. 14. Do you think glaucoma can be cured by treatment?: 29. Tsai JC. A comprehensive perspective on patient adherence to yes/no topical glaucoma therapy. Ophthalmology. 2009;116:S30–S36. 15. Do you think your glaucoma eye drops are necessary for treatment?: yes/no 16. Do you think glaucoma medication is too expensive?: APPENDIX yes/no 17. In general, do you think you are compliant in applying Questionnaire: Acceptance and Attitude Toward your glaucoma medication?: yes/no an Alternate Sustained Ocular Delivery System 18. How long have you been diagnosed with glaucoma? for the Medical Treatment of Glaucoma 19. How long have you been using glaucoma medication? Please see separate information sheet about an 20. How many different types of glaucoma medication do alternative form of administering your glaucoma medica- you have? tion using subconjunctival injection. 21. How frequently do you need to apply your glaucoma 1. Would you be willing to have your glaucoma medi- medication (ie, number of times a day?) cation given by this new method? 22. Do you experience any of the following side effects 2. Age: related to your medication?: yes/no 3. Sex: 23. Burning sensation?: yes/no 4. Race: 24. Itchy eyes?: yes/no 5. Highest education level: primary school/high school/ 25. Gritty sensation?: yes/no college and above 26. Eye redness?: yes/no 6. Employment status: working/unemployed/retired 27. Bitter taste?: yes/no 7. Marital status: single/married 28. Blurred vision?: yes/no 8. Living situation: alone/with family/institutionalized care 29. Would you be willing to have subconjunctival injec- 9. Do you need help with administering your eye drops?: tions of slow-release glaucoma medication, if it costs yes/no the same as your current medication?: yes/no 10. If so, is this because of: physical difficulties (eg, with 30. Would you be willing to have subconjunctival injec- opening or squeezing the bottle) or sight difficulties (eg, tions of slow-release glaucoma medication, if it costs with seeing the bottle and aiming for the eye)? more than your current medication?: yes/no

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