Innovative bulls eye drop applicator for self-instillation of eye drops





Highlights





  • Bulls Eye Drop applicator.



  • Accurate self-instillation of eye drops.



  • Innovative pocket size mirror-based attachment.



  • Detachable for multiple uses.



Abstract


Purpose


To report the role of Bulls eye drop applicator device in self-instillation of eye drops and in prevention of wastage of medicine.


Methods


A small pocket sized device “Bulls eye drop applicator” was developed, which is a simple, handy, mirror-based attachment which can be attached to any eye drop bottle to help in accurate self-instillation of the drops in the eye. The prototype of this device was tried in ten volunteer subjects (Group 1) and 15 patients (Group 2); they were asked to use lubricating eye drops (5 ml bottle) in one eye without the device (N) and in the other eye with the device (M). The numbers of attempts for the application of eye drops were noted and the residual eye drops in the returned bottles were measured for quantitative assessment.


Results


Ten volunteers and 11/15 patients completed the study. At the completion of the study, there were a total of 232 applications of eye drops in the Group 1 N (without device) and 1 M (with device). To achieve these 232 applications, there were 330 attempts without the device and 266 attempts of instillation were needed with the device (P < 0.0001). In Group 2, there were a total of 544 applications of eye drops; to achieve this, there were 879 attempts in Group 2 N and 685 attempts of instillation in Group 2 M (p < 0.0001). The cumulative quantity of residual drops in the returned bottles collected from Group 2 N was 5.1 ml and it was 19.7 ml in Group 2 M (p = 0.001).


Conclusions


The number of attempts of instillation reduced significantly with the use of the eye drop applicator device. The use of eye drops applicator device reduced the wastage of drops from 42.2% to 14.6% in Group 1 N Vs Group 1 M and saving of about 35.7 % in Group 2 M compared to Group 2 N.



Introduction


Management of many eye diseases depends on proper compliance of patients with the use of prescribed medication, which includes proper instillation of eye drops. The diseases include acute and chronic conditions including glaucoma, dry eyes and infectious keratitis which need long term use of topical eye drops [ , ]. Clinical outcome of any disease depends on proper and successful instillation of eye drops. Incorrect ways of putting drops may result in eye injury, abrasion, congestion of the eye, allergic skin reaction and also contamination of eye drops [ ]. Self-instillation of eye drops is one of the challenging issues for patients. Correctly self-aiming the eye drops in the eye, without seeing own eye, is difficult for many patients [ ]. Consequently, the drops often fall on the eyelids or on the face and so a person generally would request somebody else (spouse/family member or a friend) to put these eye drops in the eye. When no person/ family support is available to put the drops, then the patient may not be able to put the drops at the right time resulting in delay or missing on the correct schedule of medication. Also, self-instillation may result in spillage of drops resulting in wastage of precious medicine and increasing the cost to the patients [ , ].


The problem faced by patients in self-instillation of eye drops is well recognized in ophthalmic literature [ , ] and has been researched extensively specifically in glaucoma patients [ , , ] as they need to use eye drops on long-term basis as compared to patients with other short term eye ailments. It has been shown that if the drops are not instilled properly, then the patients may have poor control of disease, leading to poor outcome and then may dropout from the treatment out of frustration [ ].


Various devices and techniques have been designed and proposed which help in self-instillation of the eye drops by aiding in positioning of the eye drop bottle or in aiming of the eye drops into the palpebral aperture of the eye. Some of these devices include funnels, sprays, modified goggles with a hole in it for holding a bottle and mirrors [ , ].


In this regard, authors have developed and studied a mirror based medical device to help patients in self-instillation of the eye drops by direct visualization of the eye drop bottle’s nozzle and palpebral aperture while instilling the eye drops ( Fig. 1 ).




Fig. 1


Design and Concept of Bulls Eye Drop Applicator Device.



Methods


The medical device, that has been named “Bulls Eye drop applicator”, comprises of an inbuilt mirror, attached at an adjustable angle to a clasp that clips on very easily to most of the eye drop bottles ( Fig. 2 A, B and C) in such a way that user can see the image of the nozzle of the eye drop bottle and his eye simultaneously ( Fig. 2 D) thereby making it easy and simple for any patient with an eye ailment to self-instill the eye drops in his eyes and also save on wastage of eye drops spilled outside the eye.




Fig. 2


(A) Prototype of the Bulls Eye drop Applicator Device. (B) Applicator device being attached to the eye drops bottle. (C) The applicator device clasped on to eye drops bottle (D) The device being used by the subject for self instillation of the eyedrops.


The prototype of this device ( Fig. 2 C) was tested in two groups. The Group 1 included ten volunteer subjects (6 males and 4 females), without any significant eye ailments and who had a refractive error (SE- spherical equivalent) ranging from +1.00 D to −3.00 D. Every subject was given two bottles of lubricating eye drops (Genteal Eye Drops, 5 ml bottle, Novartis India Limited, Mumbai, India), one bottle without the device and the other with the device attached, to be used 3–4 times in a day, in the right eye without the device (Group 1 N, N = normal instillation) and in the left eye with the device (Group 1 M, M = mirror device assisted instillation) for a period of one month or till the time when the drops in one of the bottles finished.


Group 2 included patients with minor ocular ailments such as mild dry eye, computer vision syndrome, allergic conjunctivitis or meibomitis for which they were routinely using lubricating eye drops. Group 2 included 15 patients (9 males and 6 females). Their refractive error (SE) ranged between +1.50 D to -4.00 D. In this group too, each subject was given two bottles of Genteal eye drops, one without the device and the other with the device attached. The same methodology was followed. They were also asked to use the lubricating drops in their own eyes without the device in the right eye (Group 2 N) and with the device in the left eye (Group 2 M) for a period of one month. To maintain the uniformity of the study, patients were asked to use eye drops without device in right eye and with the applicator device in the left eye, right and left hand preference was not considered while instilling the eye drops.


Each instillation event was counted as one application and the number of attempts needed to instill a drop in the eye with or without the applicator device was noted by the user in the data sheet provided to them. In addition, users in Group 2 were asked to return the used bottles (both without the mirror device and the one with the device) after one month or earlier whenever the drops in one of the bottles finished. The quantity of the residual eye drops in the returned bottles was measured with the help of a syringe. The difference between the attempts made for instillation without and with the mirror device was compared.



Statistical analysis


The statistical analysis was performed using Origin v7.0 (OriginLab Corporation, Northampton, MA, USA). Chi-square test was used to compare the proportions between the two groups, 1 N & 1 M and 2 N & 2 M. The data on quantity of residual eye drops were checked for the normality of distribution by Shapiro-Wilk test. Since the data were not distributed normally, Wilcoxon signed-rank test was applied to compare between with and without device in the patient groups. A p-value of <0.05 was considered statistically significant.



Results


All the 10 volunteers in Group 1 completed the study. At the completion of the study, there were a total of 232 applications of eye drops in each eye in the Group 1 N and 1 M. To achieve these 232 applications, there were 330 attempts without the applicator device and only 266 attempts of instillation with the device were needed. Table 1 shows the number of attempts made for instillation in Group1. In the Group 1 N, self-instillation of eye drops in first attempt could be achieved only 154/232 times (66.38 %) and in Group 1 M, the same goal was achieved 85 % times (198/232 attempts) in single attempt. The difference between these two proportions was statistically significant (p < 0.0001).



Table 1

Results of Bulls Eye Drop Applicator Device in Group 1 (Volunteer Subjects, n = 10).







































Group1 N (without device) Group 1 M (with device) P value
Total applications 232 232
Total attempts 330 266 < 0.0001
One attempt 154 (66.4 %) 198 (85.4 %) < 0.0001
Two attempts 58 (25.0 %) 34 (14.6 %) 0.0074
Three attempts 20 (8.6 %) 0 < 0.0001
Wastage 42.20 % 14.60 % < 0.0001

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Aug 11, 2020 | Posted by in OPHTHALMOLOGY | Comments Off on Innovative bulls eye drop applicator for self-instillation of eye drops

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