Managing of Dry Eye Disease During Pregnancy: Use of Sodium Hyaluronate 0.21 %

Introduction. Pregnant women are objects of special attention of physicians due to two main reasons. The first one is that the fetal life depends on the health and quality of life of a future mother. The second is associated with increased load on all organs and systems of the female body, including the organ of vision. However, manifestations of dry eye syndrome (DES) in this contingent are often not given due attention and often remain untreated, which has a negative impact on the quality of life of women during this difficult period and can lead to diseases of the anterior segment of the eye. The aim of the study was to evaluate the effectiveness of a drug based on sodium hyaluronate 0.21 % in pregnant women with dry eye syndrome due to dysfunction of the meibomian glands. Рatients and methods. The study included 60 patients (120 eyes) with dry eye syndrome with an average age of 31.45 ± 5.98 years and a follow-up period of 3 months. There were 2 groups of patients: the main group (pregnant women with DES) and the control group (non-pregnant women with DES). Patients of both groups were administered a preservative-free form of 0.21 % sodium hyaluronate three times a day for 3 months. All studied patients underwent standard methods of examination, indicators of DES were assessed along with an objective valuation of tear film parameters and meibomian glands condition by digital biomicroscopy on a MediWorks slit lamp (Precision Instruments Co., Ltd., Shanghai) at the time of first visit and at 1 and 3 months of follow-up. Results and discussion. A comparative analysis of therapy effectiveness in the main and control groups showed that OSDI scores (ocular surface disease index), non-invasive tear breakup time (NITBUT) and meibomian gland function improved after treatment in both groups. Early diagnosis and timely correction of DES manifestations in pregnant women by administration of tear replacement therapy with preservative-free sodium hyaluronate 0.21 %, as well as eyelid hygiene can improve the quality of life of this group of patients and prevent associated with DES complications. Conclusion. The selected preservative-free tear replacement therapy with sodium hyaluronate 0.21 % (Optinol® Express moisturizing) provided a combination of ocular surface moisturizing and reducing the risk of inflammatory lesions with facilitating the release of meibomian gland secretion, contributing to the effectiveness and prolongation of therapy.

1. Trubilin VN, Poluninа EG, Andzhelova DV, Evstigneeva YuV, Chinenova KV. The Functional State of Meibomian Glands and Tear Production in Pregnant Women. Ophthalmology in Russia. 2018;15(2):151–159 (In Russ,). doi: 10.18008/1816-5095-2018-2-151-159.

2. Yokoi N, Takehisa Y, Kinoshita S. Correlation of tear lipid layer interference patterns with the diagnosis and severity of dry eye. Am J Ophthalmol. 1996;122(6):818– 824. doi: 10.1016/s0002-9394(14)70378-2.

3. Worda C, Nepp J, Huber JC, Sator MO. Treatment of keratoconjunctivitis sicca with topical androgen. Maturitas. 2001;37(3):209–212. doi: 10.1016/s0378-5122(00)00181-x.

4. Lin Z, Liu Y, Lin L, Zhu B. Hormone replacement therapy benefits meibomian gland dysfunction in perimenopausal women. Medicine (Baltimore). 2016;95(31):e4268. doi: 10.1097/MD.0000000000004268.

5. Sriprasert I, Warren DW, Mircheff AK, Stanczyk FZ. Dry eye in postmenopausal women: a hormonal disorder. Menopause. 2016;23(3):343–351. doi: 10.1097/GME.0000000000000530.

6. Golebiowski B, Badarudin N, Eden J, You J, Hampel U, Stapleton F. Does endogenous serum oestrogen play a role in meibomian gland dysfunction in postmenopausal women with dry eye? Br J Ophthalmol. 2017 Feb;101(2):218–222. doi: 10.1136/bjophthalmol-2016-308473.

7. Stapleton F, Alves M, Bunya VY, Jalbert I, Lekhanont K, Malet F, Na KS, Schaumberg D, Uchino M, Vehof J, Viso E, Vitale S, Jones L. TFOS DEWS II Epidemiology Report. Ocul Surf. 2017;15:334–365. doi: 10.1016/j.jtos.2017.05.003.

8. Gayton JL. Etiology, prevalence, and treatment of dry eye disease. Clin Ophthalmol. 2009;3:405–412. doi: 10.2147/OPTH.S5555.

9. Brzheskiy VV, Egorova GB, Egorov EA. Syndrome of “dry eye” and diseases of the eye surface: clinic, diagnosis, treatment. Moscow: GEOTAR-Media; 2016 (In Russ.). 464 p. (In Russ.). ISBN 978-5-9704-3779-7. https://www.fhbook.ru/prod_show.php?object_uid=2209162

10. Montés-Micó R. Role of the tear film in the optical quality of the human eye. J Cataract Refract Surg. 2007;33(9):1631–1635. doi: 10.1016/j.jcrs.2007.06.019.

11. Nichols KK, Foulks GN, Bron AJ, Glasgow BJ, Dogru M, Tsubota K, Lemp MA, Sullivan DA. The international workshop on meibomian gland dysfunction: executive summary. Invest Ophthalmol Vis Sci. 2011;52(4):1922–1929. doi: 10.1167/iovs.10-6997a.

12. Sheppard JD, Nichols KK. Dry Eye Disease Associated with Meibomian Gland Dysfunction: Focus on Tear Film Characteristics and the Therapeutic Landscape. Ophthalmol Ther. 2023;12(3):1397–1418. doi: 10.1007/s40123-023-00669-1.

13. Laihia J, Järvinen R, Wylęgała E, Kaarniranta K. Disease aetiology-based design of multifunctional microemulsion eye drops for moderate or severe dry eye: a randomized, quadruple-masked and active-controlled clinical trial. Acta Ophthalmol. 2020;98(3):244–254. doi: 10.1111/aos.14252.

14. Guarise C, Acquasaliente L, Pasut G, Pavan M, Soato M, Garofolin G, Beninatto R, Giacomel E, Sartori E, Galesso D. The role of high molecular weight hyaluronic acid in mucoadhesion on an ocular surface model. J Mech Behav Biomed Mater. 2023;143:105908. doi: 10.1016/j.jmbbm.2023.105908.

15. Brzhesky VV, Bobryshev VA, Kim GG. The evolution of artificial tears based on hyaluronic acid. Meditsinskiy Sovet. 2023;17(23):303–309 (In Russ.). doi: 10.21518/ms2023-430.

16. Brzheskiy VV. Algorithm of selecting the tear replacement therapy in ambulatory practice. RMJ “Clinical ophthalmology”. 2018;1:13–19 (In Russ,). doi: 10.21689/2311-7729-2018-18-1-13-19.

17. Postorino EI, Rania L, Aragona E, Mannucci C, Alibrandi A, Calapai G, Puzzolo D, Aragona P. Efficacy of eyedrops containing cross-linked hyaluronic acid and coenzyme Q10 in treating patients with mild to moderate dry eye. Eur J Ophthalmol. 2018;28(1):25–31. doi: 10.5301/ejo.5001011.

18. Pinto-Fraga J, López-de la RA, Blázquez AF, Urbano RR, González-García MJ. Efficacy and Safety of 0.2% Hyaluronic Acid in the Management of Dry Eye Disease. Eye Contact Lens. 2017;43(1):57–63. doi: 10.1097/ICL.0000000000000236.

19. Fogagnolo P, Giannaccare G, Mencucci R, Villani E, Orfeo V, Aragona P. Italian Dry Eye Study Group. Effectiveness of a New Active Tear Substitute Containing 0.2% Hyaluronic Acid and 0.001% Hydrocortisone on Signs and Symptoms of Dry Eye Disease by Means of Low- and High-Tech Assessments. Ophthalmol Ther. 2024;13(1):251–266. doi: 10.1007/s40123-023-00833-7.

20. Roberti G, Agnifili L, Berardo F, Riva I, Figus M, Manni G, Quaranta L, Oddone F. Prospective, Randomized, Single Masked, Parallel Study Exploring the Effects of a Preservative-Free Ophthalmic Solution Containing Hyaluronic Acid 0.4% and Taurine 0.5% on the Ocular Surface of Glaucoma Patients Under Multiple Long-Term Topical Hypotensive Therapy. Adv Ther. 2018;35(5):686–696. doi: 10.1007/s12325-018-0699-8.

21. Hashimoto Y, Yamana H, Michihata N, Shigemi D, Ishimaru M, Matsui H, Yasunaga H, Aihara M. Eye drops for dry eye disease during pregnancy and adverse neonatal outcomes: high-dimensional propensity score analyses. Ophthalmic Epidemiol. 2022;29(4):384–393. doi: 10.1080/09286586.2021.1971263.

22. Guarise C, Acquasaliente L, Pasut G, Pavan M, Soato M, Garofolin G, Beninatto R, Giacomel E, Sartori E, Galesso D. The role of high molecular weight hyaluronic acid in mucoadhesion on an ocular surface model. J Mech Behav Biomed Mater. 2023;143:105908. doi: 10.1016/j.jmbbm.2023.105908.

23. Ozcura F, Aydin S, Helvaci MR. Ocular surface disease index for the diagnosis of dry eye syndrome. Ocul Immunol Inflamm. 2007;15(5):389–393. doi: 10.1080/09273940701486803.

24. Echieh CI, Etim BA, Echieh CP, Oyeniyi T, Ajewole J. A comparative assessment of dry eye disease among outdoor street sweepers and indoor office cleaners. BMC Ophthalmol. 2021;21(1):265. doi: 10.1186/s12886-021-02025-y.

25. Park Y, Kim H, Kim S, Cho KJ. Effect of low-level light therapy in patients with dry eye: a prospective, randomized, observer-masked trial. Sci Rep. 2022;12(1):3575. doi: 10.1038/s41598-022-07427-6.

26. Jiang X, Lv H, Song H, Zhang M, Liu Y, Hu X, Li X, Wang W. Evaluation of the Safety and Effectiveness of Intense Pulsed Light in the Treatment of Meibomian Gland Dysfunction. J Ophthalmol. 2016;2016:1910694. doi: 10.1155/2016/1910694.

27. Chen C, Chen D, Chou YY, Long Q. Factors influencing the clinical outcomes of intense pulsed light for meibomian gland dysfunction. Medicine (Baltimore). 2021;100(49):e28166. doi: 10.1097/MD.0000000000028166.

28. Polunin GS, Zabegajlo AO, Makarov IA, Safonova TN, Polunina EG. Efficacy of lid hygiene in treatment of patients with blepharoconjunctival form of dry eye syndrome. Vestnik oftal’mologii.2012;128(1):37–40 (In Russ.).

29. Skare TL, Gehlen ML, Silveira DM, Uema MM. Gravidez e disfunção lacrimal [Lacrimal dysfunction and pregnancy]. Rev Bras Ginecol Obstet. 2012;34(4):170–174. Portuguese. doi: 10.1590/s0100-72032012000400006.

30. Mircheff AK, Wang Y, Li M, Pan BX, Ding C. Pregnancy probabilistically augments potential precursors to chronic, immune-mediated or autoimmune lacrimal gland infiltrates. Ocul Surf. 2018;16(1):120–131. doi: 10.1016/j.jtos.2017.09.005.

31. Duran M, Güngör İ. The effect of pregnancy on tear osmolarity. Cont Lens Anterior Eye. 2019;42(2):196–199. doi: 10.1016/j.clae.2018.10.007.

32. Nkiru ZN, Stella O, Udeh N, Polycarp UA, Daniel CN, Ifeoma RE. Dry eye disease: A longitudinal study among pregnant women in Enugu, south east, Nigeria. Ocul Surf. 2019;17(3):458–463. doi: 10.1016/j.jtos.2019.05.001.

33. Asiedu K, Kyei S, Adanusa M, Ephraim RKD, Animful S, Ali-Baya SK, Akorsah B, Sekyere MA. Dry eye, its clinical subtypes and associated factors in healthy pregnancy: A cross-sectional study. PLoS One. 2021;16(10):e0258233. doi: 10.1371/journal.pone.0258233.

34. Kunduracı MS, Koçkar A, Helvacıoğlu Ç, Kırık F, Karakuş HG, Akçay BİS. Evaluation of dry eye and meibomian gland function in pregnancy. Int Ophthalmol. 2023;43(11):4263–4269. doi: 10.1007/s10792-023-02836-6.

35. Madike R, Cugati S, Qin Q, Chen C. Pregnancy and the eye: What do we need to watch out for? A review. Clin Exp Ophthalmol. 2024; 52(2): 234–247. doi: 10.1111/ceo.14346.

36. Blétry O, Molina V, Somogyi A. Surveillance biologique des pathologies auto-immunes pendant la grossesse [Biological monitoring of autoimmune diseases during pregnancy]. Gynecol Obstet Fertil. 2003;31(2):151–156. French. doi: 10.1016/s1297-9589(03)00011-0.

37. Upala S, Yong WC, Sanguankeo A. Association between primary Sjögren’s syndrome and pregnancy complications: a systematic review and meta-analysis. Clin Rheumatol. 2016;35(8):1949–1955. doi: 10.1007/s10067-016-3323-9.