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

Abstract

IntroductionThe 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 analysisThe 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 disseminationThis 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 numberjRCT1031210018.

Comparison of non-pharmaceutical treatments for evaporative dry eye: a randomised controlled study protocol

“…The block size will be concealed from other researchers and the randomisation table will not be available for assessment by anyone else involved in the study. 42 Randomisation is performed by an independent biostatistician. The biostatistician is the only one who has access to check the file.…”

P4 Medicine for Heterogeneity of Dry Eye: A Mobile Health-based Digital Cohort Study

“…Dry eye presents a wide range of subjective symptoms, including ocular dryness, eye discomfort, decreased vision, and generalized fatigue [28][29][30][31] , which demonstrates a high degree of heterogeneity in its symptomology on an individual basis. Dry eye symptoms have been reported to negatively affect one's quality of vision and work productivity, ultimately resulting in financial burden and societal economic loss [32][33][34][35][36][37][38] . However, the mainstay approach to dry eye management revolves around post-facto treatment of symptoms and suppression of further exacerbation; dry eye currently has no cure 39) .…”

Protocol for a parallel assignment prospective, randomised, double-blinded, placebo-controlled trial to evaluate the efficacy of 0.01% atropine for near work-induced transient myopia and myopic progression in China

“…The block size will be concealed from other researchers, and the randomisation table will not be available for assessment by anyone involved in the study. 17 An independent biostatistician performs randomisation. The biostatistician is the only one who has access to check the file.…”