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.

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. 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. 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. jRCT1031210018.

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Déclaration de conflit d'intérêts

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.