Usage of 0.4% Sodium Hyaluronate in Complex Treatment of Pediatric Patients with Dry Eye Syndrome against the Background of Allergic Diseases of the Organ of Vision

Abstract. Background. In recent years, the prevalence of allergic diseases of the anterior segment of the eye has increased. They are often accompanied by the development of dry eye syndrome, which can complicate their course. Therefore, it is important to take a comprehensive approach to their diagnosis and treatment. Purpose: to study the effectiveness of 0.4% sodium hyaluronate (Gilays) in children with dry eye syndrome against the background of allergic diseases of the conjunctiva. Materials and methods. The study involved 42 patients (84 eyes) aged 3 to 18 years, who were examined and treated at the Commercial Non-for-profit Enterprise “Regional Eye Clinic” of Mykolaiv Regional Council. Patients were treated with local H1-histamine receptor blockers twice a day for 14 days; if indicated — with topical glucocorticoids according to a regimen for 12 days. In the first group (21 patients/42 eyes), drugs containing 0.2% sodium hyaluronate were added to the main treatment and used topically 4 times a day for 14 days. In the second group (21 patients/42 eyes), 0.4% sodium hyaluronate (Gilays) was added to the treatment regimen and used topically twice a day. H1-histamine receptor blockers were not used systemically. Before the start of therapy and 2 weeks after, the following parameters were assessed: changes in the anterior segment of the eye using biomicroscopy, determination of tear film break-up time, Schirmer 1 test, modified questionnaire. Conclusions. The use of sodium hyaluronate preparations in the complex therapy of dry eye syndrome in allergic eye diseases is quite effective. The use of 0.4% sodium hyaluronate proved to be more effective compared to the control group. It is advisable to use a questionnaire to communicate with the child; however, the form of questions needs to be refined to eliminate as much subjectivity from the data obtained as possible.

Keywords: 0.4% sodium hyaluronate; dry eye syndrome; allergic conjunctivitis

Introduction

According to various authors, the number of patients with dry eye syndrome (DES) worldwide ranges from 5 to 50% [5, 10, 11]. Dry eye syndrome is a multifactorial disease of the lacrimal apparatus and ocular surface, manifesting with symptoms of discomfort, impaired vision, and instability of the tear film with potential damage to the tissues of the eye [3, 11]. Allergic diseases are among the possible modifiable risk factors for the development of DES [3, 11]. The prevalence of dry eye syndrome in allergic diseases is 10–35.8% [7, 9].

The prevalence of allergic eye diseases worldwide is 10–30% [10]. About 90% of them are allergic conjunctivitis [10]. Allergic diseases of the conjunctiva are detected in more than 50% of patients with systemic allergy. One of the mechanisms for the development of DES in allergic conjunctivitis is conjunctival oedema, which causes mechanical compression of the capillaries and accessory lacrimal glands of the conjunctiva, resulting in reduced filtration of fluid into the accessory lacrimal glands and decreased secretion production. In addition, the use of local anti-allergy medications containing preservatives may also contribute to this [5]. The development of dry eye syndrome can aggravate the course of allergic diseases due to tear film instability, which leads to additional traumatisation of the conjunctiva and increased contact between the allergen and the body, and intensifies inflammation, which in turn worsens the course of the disease [2].

Treatment of allergic diseases of the conjunctiva requires a comprehensive approach. Today, the generally accepted standard is the use of local forms of H1-histamine receptor blockers and sodium cromoglicate, which affect the pathogenesis of allergic diseases. In cases of pronounced inflammatory reaction, instillation of glucocorticoids is possible [2].

The use of systemic H1-histamine receptor blockers must be approached with caution. They are one of the risk factors for the development of DES due to anticholinergic activity and may affect G-protein-coupled muscarinic receptors in the islets of lacrimal glands and secretory cells of the conjunctiva [10].

The use of preparations containing preservatives (benzalkonium chloride) should be avoided. Even at low concentrations, the substance accumulates in the conjunctival-corneal matrix and causes adverse effects [3, 10].

Some studies recommend adding tear substitutes to the treatment regimen for allergic eye diseases [1, 3, 5].

The most common component of tear substitutes is sodium hyaluronate [3, 5]. It is a biocompatible, water-soluble polysaccharide with hygroscopic properties, produced by biotechnological methods, possessing regenerative properties, and capable of stimulating cell migration and proliferation [3, 5].

Currently, sodium hyaluronate for instillation is available in two concentrations — 0.21% and 0.4%.

Gilays is a 0.4% sodium hyaluronate solution that contains no preservatives.

Purpose: to study the effectiveness of 0.4% sodium hyaluronate (Gilays) in children with dry eye syndrome against the background of allergic diseases of the conjunctiva.

Materials and Methods

The study involved 42 patients (84 eyes) aged 3 to 18 years, who were examined and treated at the Commercial Non-for-profit Enterprise “Regional Eye Clinic” of Mykolaiv Regional Council. Patients were treated with local H1-histamine receptor blockers (olopatadine) twice a day for 14 days; if indicated, topical glucocorticoids (dexamethasone) were used according to a regimen for 12 days. In the control group (21 patients/42 eyes), drugs containing 0.2% sodium hyaluronate were added to the main treatment and used topically 4 times a day for 14 days. In the second group (study group) (21 patients/42 eyes), 0.4% sodium hyaluronate (Gilays) was added to the treatment regimen and used topically twice a day. H1-histamine receptor blockers were not used systemically. Before the start of therapy and 2 weeks after, the following parameters were assessed: changes in the anterior segment of the eye using biomicroscopy, determination of tear film break-up time, Schirmer 1 test, a questionnaire comprising 7 questions from the OSDI questionnaire. Statistical processing of results was performed using Student’s t-test.

Results

After examining the condition of the children before and after treatment according to the above-described regimen, the following results were obtained. When studying the tear film break-up time, it was found that before the start of treatment it was 6.14 ± 2.80 s in the control group and 6.19 ± 3.38 s in the study group. Two weeks after the start of treatment, this parameter increased in both groups; however, in the study group the tear film break-up time was greater than in the control group: 6.71 ± 3.20 s compared to 6.47 ± 3.53 s (p < 0.01). When studying total tear production using the Schirmer 1 test, it was found that before the start of treatment the values in the control group were 14.2 ± 4.4 mm and in the study group — 14.1 ± 3.9 mm. Two weeks later, this parameter increased in both groups; however, it was significantly greater in the study group (14.95 ± 4.04) than in the control group (14.76 ± 4.2) (p < 0.01).

Biomicroscopy before the start of treatment in both groups revealed superficial conjunctival injection, follicular infiltration, eyelid margin oedema, and minor mucous discharge. After 2 weeks of treatment, the number of follicles in both groups decreased; conjunctival injection, eyelid oedema, and mucous discharge were absent.

The OSDI questionnaire was used as the basis for the survey; however, not all questions were appropriate for paediatric patients. Therefore, a questionnaire consisting of 7 questions taken from the OSDI was used in the study. Before treatment, the scores corresponded to a moderate degree of dry eye syndrome; after 2 weeks, the scores in both groups were within the normal range, but the results were statistically non-significant.

Discussion

The higher values of tear film break-up time and total tear production in the group of patients who used 0.4% sodium hyaluronate (Gilays) in addition to the main treatment are, in our opinion, related to the fact that the more viscous consistency of the preparation creates a barrier between the conjunctiva and the allergen, stabilises the tear film, thereby reducing the effect of pathogenetic mechanisms leading to the development of dry eye syndrome, and breaking the vicious cycle whose links mutually aggravate the course of the condition. The possibility of less frequent use of Gilays compared to 0.2% sodium hyaluronate is important in paediatric practice: twice-daily application allows parents to independently monitor the frequency and correctness of instillations without interrupting the child’s attendance at school or nursery. In our opinion, it is important to communicate with the child in order to identify the factors affecting their quality of life. Questionnaires can be helpful in this regard. However, this method is not sufficiently objective: the possibility of simulation, aggravation, and dissimulation on the part of the patient cannot be excluded.

Conclusions

1. The use of 0.4% sodium hyaluronate (Gilays) is effective in the complex treatment of children with dry eye syndrome against the background of allergic conjunctivitis.

2. It is advisable to use a questionnaire to communicate with the child; however, the form of questions needs to be refined to eliminate as much subjectivity from the data obtained as possible.

Conflicts of interests. The authors performed the investigation under the sponsorship of JSC “Kyiv Vitamin Plant”.

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