Safety and efficacy of combined acupuncture (body and intradermal acupuncture) for dry eye disease: study protocol for a pilot, single-centre, assessor-blinded, randomised, artificial tear drop-controlled trial at Naju Dongshin University Korean Medicine Hospital.

INTRODUCTION: The prevalence of dry eye disease (DED) has been consistently increasing yearly. However, the radical therapy has not yet been established. This study is to confirm the superiority of acupuncture over artificial tear drops (ATDs) in patients with DED. METHODS AND ANALYSIS: This study is a single-centre, investigator-initiated, assessor-blinded, parallel randomised controlled trial. 30 participants will be enrolled. Over a period of 4 weeks, the experimental group would receive two kinds of acupuncture three times a week. First, body acupuncture would be performed on bilateral BL2, GB14, TE23, EX-HN5 and ST1 for 15 min. Thereafter, intradermal acupuncture would be performed on the same acupoints for 4 hours. On the other hand, the control group would apply the provided ATD at least four times a day. As a rescue medication for severe DED symptoms, both groups can additionally apply ATD. The frequency of ATD use would be recorded during the trial. The primary outcomes are the Ocular Surface Disease Index and tear film break-up time. The secondary outcomes are subjective symptom Visual Analogue Scale, quality of life, Schirmer I test, tear lactoferrin level, treatment satisfaction and safety. The outcomes would be mostly assessed at visits 1, 13 and 14. ETHICS AND DISSEMINATION: This study was approved by the institutional review board of Naju Dongshin University Korean Medicine Hospital (Approval No. NJ-IRB-23-5). The obtained results will be disseminated through publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: KCT0008563.

The Association Between Taxane Use and Lacrimal Disorders.

PURPOSE: The current study seeks to investigate the association between lacrimal disorders and the use of docetaxel and paclitaxel. METHODS: A disproportionality analysis was conducted using the United States FDA Adverse Event Reporting System (FAERS). All adverse event reports containing the term docetaxel or paclitaxel were selected. Lacrimal adverse events were identified using the lacrimal disorders Standardized MedDRA Query (SMQ), which includes disorders that affect lacrimal gland and drainage system including blockage of nasolacrimal duct, occlusion/stenosis of punctum, lacrimal gland neoplasms, and inflammations and infections. RESULTS: The proportionate reporting ratio (PRR) comparing lacrimal events among docetaxel to paclitaxel users was 2.47 (95% CI, 2.03-3.02). With respect to specific lacrimal events, dacryostenosis (PRR 19.54 [95% CI, 7.19-53.13]), increased lacrimation (PRR 3.2 [95% CI, 2.42-4.23]), lacrimation disorder (p = 0.02), and xeropthalmia reports (p > 0.001) were significantly more common. CONCLUSIONS: The growing body of epidemiologic, clinical, and pathophysiologic research supports the case that docetaxel leads to adverse lacrimal events in certain patients and should be taken into consideration when oncologists consider docetaxel vs. paclitaxel.

Protocol for a parallel assignment prospective, randomised, comparative trial to evaluate the safety and efficacy of intense pulsed light (IPL) combined with 3% diquafosol (DQS) ophthalmic solution in dry eye syndrome.

INTRODUCTION: Evaporative dry eye (EDE) is common and can lead to ocular pain, decreased visual quality and reduced quality of life. Intense pulsed light (IPL) and 3% diquafosol ophthalmic solution have been found to be beneficial in reducing signs and symptoms of dry eye. METHODS AND ANALYSIS: A randomised clinical trial will be performed at He Eye Specialist Hospital in Shenyang. 360 dry eye disease patients will be equally divided randomly into the IPL group, DQS group (3% diquafosol ophthalmic solution eye-drops) and IPL+group (IPL combined with 3% diquafosol eye-drops). All groups will be followed up for 4 weeks. The primary outcome measures will be the non-invasive tear break-up time and the Ocular Surface Disease Index change from the baseline. The secondary outcome measures willincludeconjunctival and cornea staining with fluorescein and lissamine, meibomian gland function and secretion quality, tear film lipid layer score, tear meniscus height, conjunctival hyperemia (redness score) changes . Adverse events also will be monitored and documented. DISCUSSION: This study aimed to assess whether the combination of IPL with 3% diquafosol ophthalmic solution (study group), IPL+ (study group), is more effective than IPL (active control group) or DQS (active control group) in participants with EDE. ETHICS AND DISSEMINATION: Management of dry eye with IPL combined with 3% diquafosol ophthalmic solution, registered on 23 January 2023. Ethics approval number: IRB (2022) K029.01. The study's findings will be shared regardless of the effect's direction. TRIAL REGISTRATION NUMBER: NCT05694026.

Longitudinal association of thyroid-stimulating immunoglobulin levels with clinical characteristics in thyroid eye disease.

OBJECTIVES: The clinical course of thyroid eye disease (TED) is heterogeneous and predicting patients who may develop the severe sequelae of the disease is difficult. In this study, we evaluated the longitudinal association between changes in serum thyroid-stimulating hormone (TSH) receptor antibody (TRAb) levels and course of disease activity and severity over time. DESIGN: This was a multicentre, prospective, observational study. SETTING: Fifteen tertiary care oculoplastic service centres in Korea. PARTICIPANTS: Seventy-six patients with newly diagnosed TED were included and followed up for 12 months. METHODS: We evaluated clinical characteristics and serum TRAb levels at baseline, 6 and 12 months of TED diagnosis. Additionally, we analysed longitudinal associations between the serum TRAb levels and clinical activity score (CAS), no signs or symptoms, only signs, soft tissue involvement, proptosis, extraocular muscle involvement, corneal involvement, sight loss (NOSPECS) score and proptosis. RESULTS: Thyroid-stimulating immunoglobulin (TSI) and TSH-binding inhibitory immunoglobulin (TBII) levels decreased during the 1-year follow-up, whereas disease activity measured using CAS decreased mainly in the first 6 months. Disease severity measured using NOSPECS score and proptosis remained unchanged. Moreover, inter-person differences in TBII levels were associated with CAS, NOSPECS score and proptosis over time, whereas inter-person differences in TSI levels were associated with NOSPECS score. Subgroup analysis of patients with a baseline CAS≥4 demonstrated that within-person changes in TSI levels affected the CAS and NOSPECS score. CONCLUSIONS: Follow-up measurement of serum TSI and TBII levels may help evaluate TED prognosis and enable accurate clinical decision-making.

Balloon catheter dilation as the primary treatment of congenital nasolacrimal duct obstruction.

PURPOSE: The aim of this study is to report the outcome of balloon catheter dilation as the primary treatment of congenital nasolacrimal duct obstruction in children of all ages. METHODS: A 10-year retrospective study of 148 children (270 eyes), aged 9 to 159 months (mean age: 29.6 ± 17.7 months), who previously had not undergone a nasolacrimal surgical procedure and who presented with clinical signs of nasolacrimal duct obstruction, was conducted. All children underwent balloon catheter dilation of the nasolacrimal duct. RESULTS: Treatment success, defined as complete resolution of nasolacrimal duct obstruction symptoms present at follow-up visits at 1 week and up to 6 months after surgery, was 87% (234 of 270 eyes). Partial success was defined as occasional tearing which was acceptable to parents and present in 3% (nine eyes). Only 10% of the children underwent a second procedure due to complete failure. In a sub-analysis by age groups-under 18 months, between 18 and 36 months, and above 36 months-complete resolution rates were 85%, 93%, and 77%, and partial success rates were 3%, 3%, and 4%, respectively. There was a statistically significant difference between the age groups (p = .007). CONCLUSION: In this large cohort of patients with nasolacrimal duct obstruction, balloon catheter dilation was successful as a primary treatment for congenital nasolacrimal duct obstruction, particularly under the age of 36 months.

Care and outcomes of Canadian children hospitalised with periorbital and orbital cellulitis: protocol for a multicentre, retrospective cohort study.

INTRODUCTION: Skin and soft tissue infections of the eye can be classified based on anatomic location as either anterior to the orbital septum (ie, periorbital cellulitis) or posterior to the orbital septum (ie, orbital cellulitis). These two conditions are often considered together in hospitalised children as clinical differentiation is difficult, especially in young children. Prior studies have identified variation in management of hospitalised children with orbital cellulitis; however, they have been limited either as single centre studies or by the use of administrative data which lacks clinical details important for interpreting variation in care. We aim to describe the care and outcomes of Canadian children hospitalised with periorbital and orbital cellulitis. METHOD AND ANALYSIS: This is a multisite retrospective cohort study including previously healthy children aged 2 months to 18 years admitted to hospital with periorbital or orbital cellulitis from 2009 to 2018. Clinical data from medical records from multiple Canadian hospitals will be collected, including community and academic centres. Demographic characteristics and study outcomes will be summarised using descriptive statistics, including diagnostic testing, antibiotic therapy, adjunctive therapy, surgical intervention and clinical outcomes. Variation will be described and evaluated using χ² test or Kruskal-Wallis test. Generalised linear mixed models will be used to identify predictors of surgical intervention and longer length of stay. ETHICS AND DISSEMINATION: Approval of the study by the Research Ethics Board at each participating site has been obtained prior to data extraction. Study results will be disseminated by presentations at national and international meetings and by publications in high impact open access journals. By identifying important differences in management and outcomes by each hospital, the results will identify areas where care can be improved, practice standardised, unnecessary diagnostic imaging reduced, pharmacotherapy rationalised and where trials are needed.

The feasibility of finger prick autologous blood (FAB) as a novel treatment for severe dry eye disease (DED): protocol for a randomised controlled trial.

INTRODUCTION: Patients with severe dry eye disease (DED) often have limited treatment options with standard non-surgical management focused on the use of artificial tears for lubrication and anti-inflammatory drugs. However, artificial tears do not address the extraordinary complexity of human tears. Crudely, human tears with its vast constituents is essentially filtered blood. Blood and several blood-derived products including autologous serum, have been studied as tear substitutes. This study proposes to test the use of whole, fresh, autologous blood obtained from a finger prick for treatment of severe DED. METHODS AND ANALYSIS: The research team at the two participating sites will approach patients with severe DED for this study. Recruitment will take place over 12 months and we expect to recruit 60 patients in total. The primary outcome of this feasibility study is to estimate the proportion of eligible patients approached who consent to and comply with study procedures including treatment regimen and completion of required questionnaires. The secondary outcome measures, although not powered for in this feasibility, include corneal inflammation (assessed by the Oxford corneal staining guide), patient pain and symptoms scores (assessed by the Ocular Surface Disease Index Score), and objective signs of DED as indicated by visual acuity (assessed by Schirmer's test, tear break-up time, lower and/or upper tear meniscus height measurement). Other secondary outcomes include patients' quality of life (assessed using the validated EQ-5D-5L Questionnaire), cost to the National Health Service (NHS) and patient (assessed via use of NHS services and privately purchased over-the-counter treatment related to DED) and safety measure of pressure within the eye (assessed by the Intraocular Pressure (IOP) Score). ETHICS AND DISSEMINATION: This protocol and any subsequent amendments, along with any accompanying material provided to the participant in addition to any advertising material used in this trial have been approved by the East of England - Cambridgeshire and Hertfordshire Research Ethics Committee (REC reference: 17/EE/0508). Written approval from the committee was obtained and subsequently submitted to the respective Trust's Research and Development (R&D) office with final NHS R&D approval obtained. Data obtained from this study will be published in a suitable peer-review journal and will also presented at international ophthalmic conferences including the American Academy of Ophthalmology, the Royal College of Ophthalmology Annual Congress, the Association for Research and Vision and Ophthalmology, and the European Society of Cataract and Refractive Surgery. Information will be provided to patient groups and charities such as the Sjogren's Society and the Royal National Institute of Blind People. This will also be shared with the study participants as well as with relevant patient groups and charities. TRIAL REGISTRATION NUMBER: NCT03395431; Pre-results.

Success Rates of Endoscopic-Assisted Probing Compared to Conventional Probing in Children 48 Months or Older.

BACKGROUND: To evaluate the success rates of endoscopic-assisted probing compared to conventional probing in children 48 months or older. METHODS: This retrospective study included children 48 months and older with CNLDO who underwent endoscopic-assisted probing or conventional probing between January 2011 to August 2015 at a tertiary eye care hospital in central Saudi Arabia. Probing was considered successful when signals of tearing or discharge disappeared and fluorescein dye disappearance test (FDDT) was normal. Demographic data, clinical features, intraoperative and postoperative variables were correlated to the success rate. RESULTS: One hundred and twelve children with CNLDO undergoing endoscopic-assisted (37 patients) or conventional (75 patients) probing were included. The success rates of endoscopic-assisted and conventional probing were 94.6% [95% confidence interval (CI): 89.5-99.7] and 58.7% [95% (CI): 47.6-69.8], respectively. The success rate was higher with endoscopic probing, especially in older children. CONCLUSIONS: Endoscopic-assisted probing can achieve better outcomes to treat CNLDO, even in older children. The significantly higher success rates with endoscopic probing are likely due to the ability to observe and treat associated problems.