Abstract
Background
The treatment of epiphora has undergone tremendous change in the past, and minimally invasive techniques are being preferred over traditional surgical options. One of them is the use of Inj Botulinum toxin, but there are very few studies that have explored its role in treating post-traumatic epiphora. This study was undertaken to find out the safety and efficacy of injection Botulinum toxin in treating epiphora due to canalicular obstruction following trauma.
Methods
A longitudinal interventional study was done, and a total of 50 patients were recruited. All patients were subjected to Inj Botulinum toxin in the lacrimal gland (10 units). The study was done for a period of 6 months, and patients were followed up for a period of another 6 months. Changes in Munk score, Schirmer test, and tear meniscus height were considered the main outcome measures.
Results
In our study, there were 38 males and 12 females. The age of the patients varied from 24 yrs to 67 yrs. Inj Botulinum toxin was found to be effective in 80% (n = 40/50) of cases as they reported a reduction in watering from eyes after administration of this injection. The complication associated with this treatment was minimal in our study as four patients reported diplopia, whereas two patients developed Ptosis that resolved spontaneously within two months.
Conclusion
Inj Botulinum toxin was found to be effective in epiphora caused by canalicular obstruction due to trauma. This treatment should be considered as an alternative treatment modality as it often leads to satisfactory reduction in epiphora in patients with less complications compared to surgical intervention.
Keywords: Epiphora, Canalicular obstruction, Botulinum toxin
Introduction
Epiphora due to canalicular obstruction affects a significant number of patients. It hampers their quality of life by causing blurred vision, irritation in the eyes, and social embarrassment.1 The treatment of canalicular obstruction is canalicular trephination and External Dacryocystorhinostomy when the obstruction is distal and Conjunctivodacryocystorhinostomy with Jones tube intubation in proximal canalicular obstruction.2 Canalicular trephination always results in recurrence of the problem due to stenosis and fibrosis, whereas Jone's tube has a high rate of displacement.3,4 The need for one more procedure to address these issues results in dissatisfaction among patients. Inj Botulinum toxin is emerging as an alternative to surgical treatment in these cases as it decreases basal and reflex secretion of tears by inhibiting the release of the neurotransmitter acetylcholine at neuromuscular junction.5 There are very few published studies worldwide and in India, which reported the use of Botulinum toxin in treating epiphora secondary to canalicular obstruction due to trauma.5, 6, 7 There is no clarity on the dosage, number of injections required and duration of effect in various published data about the role of Botulinum toxin in proximal lacrimal drainage disorders. Hence, this study was conducted to find out how safe and effective is Inj Botulinum toxin in epiphora in patients occurring due to post-traumatic canalicular obstruction and how often we have to repeat the injection for controlling epiphora.
Material and methods
A prospective interventional study was conducted over a period of 6 months from July 2019 to Dec 2019 in the eye department of a tertiary care center. A total of 50 patients diagnosed with canalicular obstruction were included in this study after taking informed consent. This study was approved by the institutional review board and adhered to the tenets of the declaration of Helsinki.
Patients who developed canalicular obstruction following trauma and who had already undergone surgery for obstruction with failed surgical outcomes were included in the study. All these cases were referred to a higher center initially after injury where they underwent canalicular tear repair in case of fresh canalicular laceration (n = 14), canalicular trephination with silicone stent intubation (n = 20), and conjunctivodacryocystorhinostomy with Jones tube (n = 16) in cases of old canalicular tear leading to obstruction. Surgical outcomes were not satisfactory in these cases, and they continued to have epiphora. Repeat intervention was recommended in all these cases; hence, we enrolled all of them for the current study.
Patients with nasolacrimal duct obstruction, fresh canalicular tear, and functional epiphora were excluded from this study.
In all cases, history was taken, and all of them underwent detailed ocular examination, which included vision, refraction, slit lamp, and fundus examination. Lacrimal irrigation test was done in all cases under topical anesthesia. The location of canalicular obstruction was measured by inserting a lacrimal probe and measuring with scale. In 38 patients, proximal blockage (<5 mm from the punctum) and in 12 patients distal canalicular obstruction (>5 mm from punctum) was found.8 Munk Score evaluation (Table 1) and Schirmer 1 test (Table 2) were done in all cases.9, 10, 11 Tear meniscus height which indicates the tear volume was also measured in all cases with the help of slit-lamp examination. Normal tear meniscus height is 0.3–0.4 mm.12
Table 1.
Munk Score (Epiphora grading score).
| Grade | Features |
|---|---|
| 0 | No epiphora |
| 1 | Occasional epiphora requiring wiping with a tissue less than twice a day |
| 2 | Epiphora requiring 2–4 wipings per day |
| 3 | Epiphora requiring 5–10 wipings per day |
| 4 | Epiphora requiring wipings more than 10 times per day |
| 5 | Constant tearing |
Table 2.
Schirmer score.
| Grade | Value |
|---|---|
| Normal | 15–25 mm |
| Epiphora | >25 mm |
| Mild Dryness | 10–15 mm |
| Moderate Dryness | 05–10 mm |
| Severe Dryness | 00–05 mm |
All patients (n = 50) were given 10 units of Inj Botulinum toxin under strict aseptic conditions during the study period, and all were followed up for another 6 months. In all patients, the injection was given by a single surgeon on an outpatient basis. The lacrimal gland measures approximately 20 mm long by 12 mm wide by 5 mm thick.13 Therefore, 0.4 ml (10 units) of Botulinum toxin was injected as there is enough volume available inside the lacrimal gland to retain this toxin.
The main outcome measures were changes in Munk score, Schirmer test score, and tear meniscus height. All these tests were repeated after one week, 1 month, 3 months, and 6 months.
Technique of injection Botulinum toxin
200 IU of freeze-dried Botulinum toxin vial was diluted with 8 ml normal saline resulting in a concentration of 25 IU/ml. After the instillation of topical anesthesia, the lateral part of the upper lid was everted over a retractor, and patients were instructed to look inferomedially so that palpebral lobe of the lacrimal gland got exposed (Fig. 1). Then 0.4 ml (10 IU) of Botulinum toxin was injected transconjunctivally into the palpebral lobe of the lacrimal gland using 30 G needle.14 Topical antibiotics with steroid drop were given three times daily for one week. Patients were reviewed on day 1, first week, one month, 3 and 6 months after the injection.
Fig. 1.
(a): Clinical photograph showing palpebral lobe of the lacrimal gland (black arrow). (b): Clinical photograph showing infiltration of Botulinum toxin in the lacrimal gland with a 30 G needle attached with insulin syringe (black arrow).
Statistical analysis. The data collected were entered in Microsoft Excel 2007 and analyzed using Epi info version 3.4.3. Mean, standard deviation, and percentages were calculated for preoperative and postoperative examination findings. Paired t-test was applied to determine any statistical difference between preinjection and postinjection findings. A p-value of <0.05 was taken as statistically significant. A ninety-five percent confidence interval for the difference of proportion was also calculated.
Results
A total of 50 patients (50 eyes) were enrolled for the study. The traumatic causes of canalicular obstruction are depicted in Fig. 2. The most common cause of canalicular obstruction (37 patients, 74%) was due to injury to the eyes sustained in a road traffic accident. In eight (16%) patients, canaliculi were damaged due to blast injuries, whereas in five (10%) patients, canalicular damage had occurred with a fist punch to the face in a boxing match. In 37 patients (74%), there were associated eyelid injuries, and 13 patients (26%) had both eyelid and open globe injuries.
Fig. 2.
Traumatic causes of canalicular obstruction.
There were 38 (76%) males and 12 (24%) females in the current study. The mean age group of the study population at the time of Inj Botox was 45.84 ± 13.58 years (range from 24 years to 67 years). In 14 (28%) cases, both upper and lower canaliculi were involved, and in 36 (72%) cases, a single canaliculi was found to be damaged. In 22 patients, the vision was found impaired due to watering. The vision in these patients was found to be 6/18. The follow-up period was of 6 months.
The preinjection and postinjection Schirmer test, tear meniscus height, and Munk score were compared (Table 3). Forty out of fifty patients reported relief of symptoms after Inj Botox, which was more evident after one week and which lasted for 3 months (Fig. 3). In all these cases, improvement in Munk score, Schirmer score, and decrease in tear meniscus height was found. The effects of Botox injection are temporary and usually last for 2–3 months.15 Hence, the need for a second injection was felt in patients who reported symptomatic relief of watering, and it was administered. Following the second injection, patients remained asymptomatic for another 3 months. Ten patients reported no relief of symptoms in the current study (Fig. 3). The administration of Inj botox did not cause any side effects in 44 patients, whereas four (8%) patients reported with diplopia and two (4%) patients with mild ptosis for which the patients were given proper counseling (Fig. 4). In these patients, both diplopia and ptosis resolved spontaneously within two months. None of the patient experienced pain during the procedure or developed hemorrhage due to the injection.
Table 3.
Comparison between preoperative and postoperative outcome parameters.
| Parameters | Preoperative mean ± SD | Postoperative mean ± SD | p-value | 95%CI |
|---|---|---|---|---|
| Munk Score | 3.54 ± 0.498 | 1.54 ± 0.498 | p < 0.0001 | 1.68 to 1.39 |
| Schirmer Test | 32.5 ± 2.5 mm | 17.6 ± 2.49 mm | p < 0.0001 | 18.31 to 16.88 |
| Tear Meniscus Height | 1.27 ± 0.24 mm | 0.374 ± 0.0715 mm | p < 0.0001 | 0.39 to 0.34 |
Fig. 3.
Clinical outcomes in our study.
Fig. 4.
Complications in our study.
Discussion
Botulinum toxin is a good alternative to surgical management in patients with canalicular obstruction with repeated surgical failures and in patients with canalicular trauma who have not undergone repair on time and then present with canalicular obstruction.
The role of Inj Botulinum toxin came into the picture, when it was first used for hyperlacrimation due to facial nerve palsy.16, 17, 18, 19 Since then, its role in epiphora due to different causes has been explored with variable outcomes.5,7,20 There are no studies that have explored the role of Inj Botulinum toxin in canalicular obstruction due to trauma. Hence, this study was conducted to evaluate the role of Inj Botulinum toxin in canalicular obstruction among clientele in our setup.
Outcome measures that were evaluated included change in Munk score, Schirmer test, tear meniscus height. In this study, there was an improvement in Munk score, Schirmer test, and decrease in tear meniscus height. Munk score decreased from a mean of 3.54 ± 0.498 to 1.54 ± 0.498 (p < 0.0001; 95% CI, 1.68 to 1.39), which was statistically significant. Schirmer score decreased from a mean of 32.5 ± 2.5 mm to 17.6 ± 2.49 mm (p < 0.0001,95% CI, 18.31 to 16.88), which was statistically significant. Tear meniscus height decreased from a mean of 1.27 ± 0.24 to 0.374 ± 0.0715 (p < 0.0001, 95% CI, 0.39 to 0.34), which was statistically significant. Hence, in our study group, Botulinum toxin was found to be an effective treatment modality in 80% of cases in reducing epiphora. This is in accordance with Ziahosseini et al who reported the effectiveness of Botox injection in 70% of cases.1 Wojno et al and Whittaker et al reported 74% efficacy of Inj Botox in their studies, whereas Girad et al reported 87% efficacy of Inj Botox in their study group.6,21,22 In 80% of cases, patients in whom blurring of vision was due to watering reported improvement in vision. Vision actually improved from 6/18 in affected eyes to 6/9 in all these cases. During the procedure, all patients were comfortable and did not complain of any pain. However, in patients who reported improvement in symptoms following administration of the first injection, Inj Botulinum toxin was repeated after 3 months as the effect of this toxin was found to last for 2–3 months.16,23 Few patients developed mild ptosis (2 patients) and diplopia (four patients) but these side effects did not affect their daily activities. Whittaker et al also reported ptosis in one patient and diplopia in one patient out of 14 patients.21 This study's finding is in concordance with Girad et al which reported ptosis in four patients and diplopia in two patients among 20 patients.22 Whereas Wojno et al reported ptosis in five patients out of 46 patients.6 Ziahosseini et al reported diplopia in one patient and hematoma in one patient.1
All patients were counseled about the temporary relief of symptoms following Inj Botulinum toxin before enrolling them for study.
Since the procedure was painless and less time-consuming, patients did not hesitate to take a second injection after 3 months.
This study is different from other studies as, in our study, we administered 10 units of Inj Botulinum toxin in lacrimal gland with good outcomes and less complications. Second, this is the first of its kind from this geographical location, which has analyzed the role of Botulinum toxin in canalicular obstruction due to trauma. Third, the no of patients recruited for this study is quite high (50) compared to other studies that have assessed the role of Botulinum toxin in epiphora due to trauma. Hence, it has not only provided more data in which Botulinum toxin was found to be effective but also shown representative results.
The only limitation of this study is that the author did not compare the effect of Botulinum toxin with conjunctivodacryocystorhinostomy.
Conclusion
Inj Botulinum toxin is a safe and effective treatment modality for treating refractory epiphora. The procedure is minimally invasive, painless, safer, and does not require much skill to perform. Injection Botulinum toxin may be considered in traumatic canalicular obstruction for a better outcome in terms of reduction in epiphora with less complications. However, the treatment is temporary, and repeated injections are required, which lead to frequent followups and regular visits to the hospital.
Disclosure of competing interest
The authors have none to declare.
References
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