Clinical efficacy of diquafosol sodium 3% versus hyaluronic acid 0.1% in patients with dry eye disease after cataract surgery: a protocol for a single-centre, randomised controlled trial

Maria Miura, Takenori Inomata, Shuko Nojiri, Jaemyoung Sung, Masashi Nagao, Jun Shimazaki, Akie Midorikawa-Inomata, Yuichi Okumura, Kenta Fujio, Yasutsugu Akasaki, Mizu Kuwahara, Tianxiang Huang, Masahiro Nakamura, Masao Iwagami, Kunihiko Hirosawa, Keiichi Fujimoto, Akira Murakami, Maria Miura, Takenori Inomata, Shuko Nojiri, Jaemyoung Sung, Masashi Nagao, Jun Shimazaki, Akie Midorikawa-Inomata, Yuichi Okumura, Kenta Fujio, Yasutsugu Akasaki, Mizu Kuwahara, Tianxiang Huang, Masahiro Nakamura, Masao Iwagami, Kunihiko Hirosawa, Keiichi Fujimoto, Akira Murakami

Abstract

Introduction: The number of cataract surgeries, the most common ophthalmic surgery, is expected to increase due to ageing populations. Dry eye disease (DED) is a frequent side effect of cataract surgery, contributing to lower postoperative patient satisfaction and suboptimal quality of vision. It is unclear which eye-drops commonly used in these patients should be recommended for postoperative DED treatment. This study aims to compare the efficacy of topical administration of diquafosol sodium 3% vs hyaluronic acid 0.1% eye-drops in patients with DED after cataract surgery.

Methods and analysis: The study is designed as a single-blind randomised controlled trial. The participants will be randomly (1:1) allocated to either the diquafosol sodium 3% topical administration group (n=21) or the hyaluronic acid 0.1% topical administration group (n=21). Each group will receive its assigned eye-drop intervention over a 12-week period. The primary outcome will be measured using the total score of the Japanese version of the Ocular Surface Disease Index during the visit 5 weeks postoperatively. Both groups will be followed up after their respective eye-drop application for 12 weeks according to the intervention regimens. Secondary outcome measures including meibomian gland function assessment, tear film break-up time, keratoconjunctival staining score, maximum blink interval and tear secretion volume using Schirmer's test I will be assessed at 1, 5, 9, 13 and 25 weeks postoperatively.

Ethics and dissemination: This study has been approved by the Juntendo Hospital Certified Review Board, Tokyo, Japan (Approved protocol V.7.0 dated 7 May 2021. Approval number: J20-018) and has been registered with the Japan Registry of Clinical Trials. Written informed consent will be collected from every patient prior to study participation. The results of this trial will be presented at local and international meetings and submitted to peer-reviewed journals for publication.

Trial registration number: jRCT1031210018.

Keywords: cataract and refractive surgery; corneal and external diseases; ophthalmology; surgery.

Conflict of interest statement

Competing interests: TI reported receiving grants from Johnson & Johnson Vision Care, Hogy Medical Co, SEED Co, Santen Pharmaceutical Co, Alcon Japan, Lion, and InnoJin Co. and personal fees from Santen Pharmaceutical Co, outside the submitted work. AM reported receiving grants from Eisai Co, Kowa, Novartis Pharma K.K., HOYA Corporation, ROHTO Pharmaceutical Co, Alcon Japan, AMO Japan K.K., Otsuka Pharmaceutical Co, SEED Co, Senju Pharmaceutical Co, Novartis Pharma K.K., Pfizer Japan, and Santen Pharmaceutical Co and personal fees from Johnson & Johnson Vision Care, Kowa, and Lion, outside the submitted work. No other disclosures were reported.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study schema.

References

    1. Song P, Sun Z, Ren S, et al. . Preoperative management of MGd alleviates the aggravation of MGd and dry eye induced by cataract surgery: a prospective, randomized clinical trial. Biomed Res Int 2019;2019:1–10. 10.1155/2019/2737968
    1. Pascolini D, Mariotti SP. Global estimates of visual impairment: 2010. Br J Ophthalmol 2012;96:614–8. 10.1136/bjophthalmol-2011-300539
    1. Stapleton F, Alves M, Bunya VY, et al. . TFOS DEWS II epidemiology report. Ocul Surf 2017;15:334–65. 10.1016/j.jtos.2017.05.003
    1. Yu Y, Hua H, Wu M, et al. . Evaluation of dry eye after femtosecond laser-assisted cataract surgery. J Cataract Refract Surg 2015;41:2614–23. 10.1016/j.jcrs.2015.06.036
    1. Hardten DR. Dry eye disease in patients after cataract surgery. Cornea 2008;27:855. 10.1097/ICO.0b013e31816f6854
    1. Li X-M, Hu L, Hu J, et al. . Investigation of dry eye disease and analysis of the pathogenic factors in patients after cataract surgery. Cornea 2007;26:S16–20. 10.1097/ICO.0b013e31812f67ca
    1. Ram J, Gupta A, Brar G, et al. . Outcomes of phacoemulsification in patients with dry eye. J Cataract Refract Surg 2002;28:1386–9. 10.1016/S0886-3350(02)01387-1
    1. Ram J, Sharma A, Pandav SS, et al. . Cataract surgery in patients with dry eyes. J Cataract Refract Surg 1998;24:1119–24. 10.1016/S0886-3350(98)80107-7
    1. Uchino M, Dogru M, Yagi Y, et al. . The features of dry eye disease in a Japanese elderly population. Optom Vis Sci 2006;83:797–802. 10.1097/01.opx.0000232814.39651.fa
    1. Inomata T, Iwagami M, Nakamura M, et al. . Characteristics and risk factors associated with diagnosed and undiagnosed symptomatic dry eye using a smartphone application. JAMA Ophthalmol 2020;138:58–68. 10.1001/jamaophthalmol.2019.4815
    1. Sánchez MA, Arriola-Villalobos P, Torralbo-Jiménez P, et al. . The effect of preservative-free HP-Guar on dry eye after phacoemulsification: a flow cytometric study. Eye 2010;24:1331–7. 10.1038/eye.2010.24
    1. Ju R-H, Chen Y, Chen H-S, et al. . Changes in ocular surface status and dry eye symptoms following femtosecond laser-assisted cataract surgery. Int J Ophthalmol 2019;12:1122–6. 10.18240/ijo.2019.07.11
    1. Khanal S, Tomlinson A, Esakowitz L, et al. . Changes in corneal sensitivity and tear physiology after phacoemulsification. Ophthalmic Physiol Opt 2008;28:127–34. 10.1111/j.1475-1313.2008.00539.x
    1. Qiu J-J, Sun T, Fu S-H, et al. . A study of dry eye after cataract surgery in MGd patients. Int Ophthalmol 2020;40:1277–84. 10.1007/s10792-020-01294-8
    1. Park Y, Hwang HB, Kim HS. Observation of influence of cataract surgery on the ocular surface. PLoS One 2016;11:e0152460. 10.1371/journal.pone.0152460
    1. Choi YJ, Park SY, Jun I, et al. . Perioperative ocular parameters associated with persistent dry eye symptoms after cataract surgery. Cornea 2018;37:734–9. 10.1097/ICO.0000000000001572
    1. Villani E, Marelli L, Bonsignore F, et al. . The ocular surface frailty index as a predictor of ocular surface symptom onset after cataract surgery. Ophthalmology 2020;127:866–73. 10.1016/j.ophtha.2019.12.012
    1. Jee D, Park M, Lee HJ, et al. . Comparison of treatment with preservative-free versus preserved sodium hyaluronate 0.1% and fluorometholone 0.1% eyedrops after cataract surgery in patients with preexisting dry-eye syndrome. J Cataract Refract Surg 2015;41:756–63. 10.1016/j.jcrs.2014.11.034
    1. Kato K, Miyake K, Kondo N, et al. . Conjunctival goblet cell density following cataract surgery with diclofenac versus diclofenac and rebamipide: a randomized trial. Am J Ophthalmol 2017;181:26–36. 10.1016/j.ajo.2017.06.016
    1. Jun I, Choi S, Lee GY, et al. . Effects of Preservative-free 3% Diquafosol in Patients with Pre-existing Dry Eye Disease after Cataract Surgery: A Randomized Clinical Trial. Sci Rep 2019;9:12659. 10.1038/s41598-019-49159-0
    1. Cho YK, Kim MS. Dry eye after cataract surgery and associated intraoperative risk factors. Korean J Ophthalmol 2009;23:65–73. 10.3341/kjo.2009.23.2.65
    1. Shao D, Zhu X, Sun W, et al. . Effects of femtosecond laser-assisted cataract surgery on dry eye. Exp Ther Med 2018;16:5073–8. 10.3892/etm.2018.6862
    1. Kohli P, Arya SK, Raj A, et al. . Changes in ocular surface status after phacoemulsification in patients with senile cataract. Int Ophthalmol 2019;39:1345–53. 10.1007/s10792-018-0953-8
    1. Cui L, Li Y, Lee HS, et al. . Effect of diquafosol tetrasodium 3% on the conjunctival surface and clinical findings after cataract surgery in patients with dry eye. Int Ophthalmol 2018;38:2021–30. 10.1007/s10792-017-0693-1
    1. Miyake K, Yokoi N. Influence on ocular surface after cataract surgery and effect of topical diquafosol on postoperative dry eye: a multicenter prospective randomized study. Clin Ophthalmol 2017;11:529–40. 10.2147/OPTH.S129178
    1. Lee H, Kim SM, Choi S, et al. . Effect of diquafosol three per cent ophthalmic solution on tear film and corneal aberrations after cataract surgery. Clin Exp Optom 2017;100:590–4. 10.1111/cxo.12521
    1. Caretti L, La Gloria Valerio A, Piermarocchi R, et al. . Efficacy of carbomer sodium hyaluronate trehalose vs hyaluronic acid to improve tear film instability and ocular surface discomfort after cataract surgery. Clin Ophthalmol 2019;13:1157–63. 10.2147/OPTH.S208256
    1. Fogagnolo P, Favuzza E, Marchina D, et al. . New therapeutic strategy and innovative lubricating ophthalmic solution in minimizing dry eye disease associated with cataract surgery: a randomized, prospective study. Adv Ther 2020;37:1664–74. 10.1007/s12325-020-01288-z
    1. Ntonti P, Panagiotopoulou E-K, Karastatiras G, et al. . Impact of 0.1% sodium hyaluronate and 0.2% sodium hyaluronate artificial tears on postoperative discomfort following cataract extraction surgery: a comparative study. Eye Vis 2019;6. 10.1186/s40662-019-0131-8
    1. Yoon DY, Kim JH, Jeon HS, et al. . Evaluation of the protective effect of an ophthalmic viscosurgical device on the ocular surface in dry eye patients during cataract surgery. Korean J Ophthalmol 2019;33:467–74. 10.3341/kjo.2019.0060
    1. He Y, Li J, Zhu J, et al. . The improvement of dry eye after cataract surgery by intraoperative using ophthalmic viscosurgical devices on the surface of cornea: the results of a consort-compliant randomized controlled trial. Medicine 2017;96:e8940. 10.1097/MD.0000000000008940
    1. Yusufu M, Liu X, Zheng T, et al. . Hydroxypropyl methylcellulose 2% for dry eye prevention during phacoemulsification in senile and diabetic patients. Int Ophthalmol 2018;38:1261–73. 10.1007/s10792-017-0590-7
    1. Devendra J, Singh S. Effect of oral lactoferrin on cataract surgery induced dry eye: a randomised controlled trial. J Clin Diagn Res 2015;9:Nc06–9. 10.7860/JCDR/2015/15797.6670
    1. Shokoohi-Rad S, Javaheri SZH, Malekabad FZ, et al. . Effects of preoperative doses of betamethasone acetate 0.1% on dry eye control after cataract surgery. Indian J Ophthalmol 2020;68:450–4. 10.4103/0301-4738.278367
    1. Eguchi A, Inomata T, Nakamura M, et al. . Heterogeneity of eye drop use among symptomatic dry eye individuals in Japan: large-scale crowdsourced research using DryEyeRhythm application. Jpn J Ophthalmol 2021;65:271–81. 10.1007/s10384-020-00798-1
    1. Kim S, Shin J, Lee JE. A randomised, prospective study of the effects of 3% diquafosol on ocular surface following cataract surgery. Sci Rep 2021;11:9124. 10.1038/s41598-021-88589-7
    1. Craig JP, Nichols KK, Akpek EK, et al. . TFOS DEWS II definition and classification report. Ocul Surf 2017;15:276–83. 10.1016/j.jtos.2017.05.008
    1. Tsubota K, Yokoi N, Shimazaki J, et al. . New perspectives on dry eye definition and diagnosis: a consensus report by the Asia dry eye Society. Ocul Surf 2017;15:65–76. 10.1016/j.jtos.2016.09.003
    1. Inomata T, Mizuno J, Iwagami M, et al. . The impact of joint Commission international accreditation on time periods in the operating room: a retrospective observational study. PLoS One 2018;13:e0204301. 10.1371/journal.pone.0204301
    1. Tsubota K, Yokoi N, Shimazaki J, et al. . New perspectives on dry eye definition and diagnosis: a consensus report by the Asia dry eye Society. Ocul Surf 2017;15:65–76. 10.1016/j.jtos.2016.09.003
    1. Keating GM. Diquafosol ophthalmic solution 3 %: a review of its use in dry eye. Drugs 2015;75:911–22. 10.1007/s40265-015-0409-7
    1. Meyer K. Chemical structure of hyaluronic acid. Fed Proc 1958;17:1075–7.
    1. Yang Y-J, Lee W-Y, Kim Y-J, et al. . A meta-analysis of the efficacy of hyaluronic acid eye drops for the treatment of dry eye syndrome. Int J Environ Res Public Health 2021;18. 10.3390/ijerph18052383. [Epub ahead of print: 01 Mar 2021].
    1. Schiffman RM, Christianson MD, Jacobsen G, et al. . Reliability and validity of the ocular surface disease index. Arch Ophthalmol 2000;118:615–21. 10.1001/archopht.118.5.615
    1. Midorikawa-Inomata A, Inomata T, Nojiri S, et al. . Reliability and validity of the Japanese version of the ocular surface disease index for dry eye disease. BMJ Open 2019;9:e033940. 10.1136/bmjopen-2019-033940
    1. Amano S. Meibomian gland dysfunction: recent progress worldwide and in Japan. Invest Ophthalmol Vis Sci 2018;59:DES87. 10.1167/iovs.17-23553
    1. van Bijsterveld OP. Diagnostic tests in the sicca syndrome. Arch Ophthalmol 1969;82:10–14. 10.1001/archopht.1969.00990020012003
    1. Inomata T, Iwagami M, Hiratsuka Y, et al. . Maximum blink interval is associated with tear film breakup time: a new simple, screening test for dry eye disease. Sci Rep 2018;8:13443. 10.1038/s41598-018-31814-7
    1. Hirosawa K, Inomata T, Sung J, et al. . Diagnostic ability of maximum blink interval together with Japanese version of ocular surface disease index score for dry eye disease. Sci Rep 2020;10:18106. 10.1038/s41598-020-75193-4
    1. Wolffsohn JS, Arita R, Chalmers R, et al. . TFOS DEWS II diagnostic methodology report. Ocul Surf 2017;15:539–74. 10.1016/j.jtos.2017.05.001
    1. Stern ME, Schaumburg CS, Pflugfelder SC. Dry eye as a mucosal autoimmune disease. Int Rev Immunol 2013;32:19–41. 10.3109/08830185.2012.748052

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