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Treatments for open-angle glaucoma aim to prevent vision loss through lowering of intraocular pressure, but to our knowledge no placebo-controlled trials have assessed visual function preservation, and the observation periods of previous (unmasked) trials have typically been at least 5 years. We assessed vision preservation in patients given latanoprost compared with those given placebo. In this randomised, triple-masked, placebo-controlled trial, we enrolled patients with newly diagnosed open-angle glaucoma at ten UK centres (tertiary referral centres, teaching hospitals, and district general hospitals). Eligible patients were randomly allocated (1:1) with a website-generated randomisation schedule, stratified by centre and with a permuted block design, to receive either latanoprost 0·005% (intervention group) or placebo (control group) eye drops. Drops were administered from identical bottles, once a day, to both eyes. The primary outcome was time to visual field deterioration within 24 months. Analyses were done in all individuals with follow-up data. The Data and Safety Monitoring Committee (DSMC) recommended stopping the trial on Jan 6, 2011 (last patient visit July, 2011), after an interim analysis, and suggested a change in primary outcome from the difference in proportions of patients with incident progression between groups to time to visual field deterioration within 24 months. This trial is registered, number ISRCTN96423140. We enrolled 516 individuals between Dec 1, 2006, and March 16, 2010. Baseline mean intraocular pressure was 19·6 mm Hg (SD 4·6) in 258 patients in the latanoprost group and 20·1 mm Hg (4·8) in 258 controls. At 24 months, mean reduction in intraocular pressure was 3·8 mm Hg (4·0) in 231 patients assessed in the latanoprost group and 0·9 mm Hg (3·8) in 230 patients assessed in the placebo group. Visual field preservation was significantly longer in the latanoprost group than in the placebo group: adjusted hazard ratio (HR) 0·44 (95% CI 0·28–0·69; p=0·0003). We noted 18 serious adverse events, none attributable to the study drug. This is the first randomised placebo-controlled trial to show preservation of the visual field with an intraocular-pressure-lowering drug in patients with open-angle glaucoma. The study design enabled significant differences in vision to be assessed in a relatively short observation period. Pfizer, UK National Institute for Health Research Biomedical Research Centre.

Aim The purpose of this study was to conduct and interpret a pooled 12-month analysis of two prospective, multi-center, randomized, double-masked, controlled trials designed to assess the efficacy and safety of the travoprost intracameral implant (slow-eluting [SE] implant in development as a new therapeutic and fast-eluting [FE] implant included for masking purposes) in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT). Methods Subjects with OAG or OHT, on 0–3 intraocular pressure (IOP)-lowering medications, baseline unmedicated mean diurnal IOP of ≥ 21 mmHg, and IOP ≤ 36 mmHg at each baseline diurnal timepoint, received either a travoprost implant and twice-daily (BID) placebo eye drops or BID timolol 0.5% eye drops and a sham procedure. Subjects were followed through 12 months and assessed for IOP, reduction in topical IOP-lowering medications, and safety parameters including treatment-emergent adverse events (TEAEs). IOP at 8AM was prospectively collected at all study visits through 12 months and diurnal IOP, measured at 8AM, 10AM, and 4PM, was prospectively collected at baseline, day 10, week 6, and months 3 and 12. Results A total of 1150 subjects were randomized (385 FE implant, 380 SE implant, and 385 sham/timolol) across the two trials. Statistical non-inferiority to timolol and clinically relevant reductions in 8AM IOPs were demonstrated at month 12. In more detail, both implant groups demonstrated statistical non-inferiority to timolol and clinically relevant reductions from baseline in mean diurnal IOP at all visits over the 12-month evaluation period when diurnal IOP was collected. Additionally, both implant groups demonstrated robust treatment effect based on 8AM average IOP from day 10 through the specified visit which ranged from day 10 to month 12 from 6.9 to 8.5 mmHg in the FE implant group; 6.8 to 8.5 mmHg in the SE implant group; and 7.3 to 7.5 mmHg in the sham/timolol group. With regards to reduction in topical pharmacotherapy, at month 12, 77.6% of FE and 81.4% of SE implant eyes were completely free of all topical IOP-lowering medications and a significantly greater proportion of FE and SE implant eyes (89.9% and 93.0%) versus sham/timolol eyes (66.9%) were on the same or fewer topical IOP-lowering medications compared with pre-study ( p <  0.0001). Furthermore, of subjects on topical IOP medications at screening, a significantly greater proportion of FE implant (80.2%) and SE implant (85.1%) eyes versus sham/timolol (22.8%) eyes were on fewer topical IOP-lowering medications at month 12 compared with pre-study ( p <  0.0001). Lastly, of SE implant eyes on same or fewer topical IOP-lowering medications at month 12, the average through month 12 decreased by 0.9 medications, and of those SE implant eyes on fewer topical IOP-lowering medications compared with pre-study, the average through month 12 decreased by 1.4 medications. The most common TEAEs related to study treatment were hyperemia (conjunctival or ocular), iritis, and IOP increased. Conclusion The travoprost intracameral implant demonstrated robust IOP-lowering efficacy that was sustained and statistically non-inferior to timolol over the entire 12 months, resulting in a significant reduction in topical IOP-lowering medication use, with the majority of SE implant eyes remaining completely free of all topical IOP-lowering medications. In addition, the implant demonstrated a favorable safety and tolerability profile based on this pooled 12-month analysis of two pivotal trials. Trial Registration ClinicalTrials.gov identifiers NCT03519386 (registered May 09, 2018) and NCT03868124 (registered March 08, 2019).

Background/aimsTo report the protocol of a trial designed to evaluate the efficacy, safety and mechanism of action of low-dose atropine (0.01%) eye-drops for reducing progression of myopia in UK children.MethodsMulticentre, double-masked, superiority, placebo-controlled, randomised trial. We will enrol children aged 6–12 years with myopia of −0.50 dioptres or worse in both eyes.We will recruit 289 participants with an allocation ratio of 2:1 (193 atropine; 96 placebo) from five centres. Participants will instil one drop in each eye every day for 2 years and attend a research centre every 6 months. The vehicle and preservative will be the same in both study arms.The primary outcome is SER of both eyes measured by autorefractor under cycloplegia at 2 years (adjusted for baseline). Secondary outcomes include axial length, best corrected distance visual acuity, near visual acuity, reading speed, pupil diameter, accommodation, adverse event rates and allergic reactions, quality of life (EQ-5D-Y) and tolerability at 2 years. Mechanistic evaluations will include: peripheral axial length, peripheral retinal defocus, anterior chamber depth, iris colour, height and weight, activities questionnaire, ciliary body biometry and chorioretinal thickness. Endpoints from both eyes will be pooled in combined analysis using generalised estimating equations to allow for the correlation between eyes within participant. Three years after cessation of treatment, we will also evaluate refractive error and adverse events.ConclusionsThe Childhood Atropine for Myopia Progression in the UK study will be the first randomised trial reporting outcomes of low-dose atropine eye-drops for children with myopia in a UK population.Trial registration number ISRCTN99883695, NCT03690089.

Symptoms and signs of dry eye can significantly increase after cataract surgery. The present study seeks to investigate the effect of intensive lubrication using Systane HYDRATION multi-dose preservative free (MDPF) eye drops (Alcon Research, Ltd., Fort Worth, Texas, USA) on signs and symptoms of dry eye in the postoperative phase. Patients scheduled for cataract surgery were enrolled in this randomised, investigator-masked study and assigned to one of three groups. The risk of developing dry eye was stratified using the ocular surface frailty index (OSFI). The high risk - standard of care (HR-SOC) and treatment (HR-Treatment) group were the high-risk groups (OSFI 0.3 or greater), and the LR-SOC group was the low-risk group (OSFI less than 0.3). HR-SOC and LR-SOC group received the standard postoperative treatment. In the HR-Treatment group, Systane HYDRATION MDPF was added four times a day for three months after surgery. After the baseline examination prior to cataract surgery, three follow up visits were scheduled one week, one month and three months after surgery. OSDI scores, ocular surface staining, and fluorescein break-up time were assessed at each visit. Ninety-five patients were included and 83 entered statistical analyses. OSDI increased in all groups after cataract surgery, and it was lowest in the HR-Treatment group three months after the surgery. In addition, fluorescein break-up time tended to be longer and ocular surface staining less in the HR treatment group at three months. However, there was no statistically significant difference between the groups during the three-month visit. In this randomized, examiner-masked trial no statistically significant difference could be found between the groups, but Systane HYDRATION MDPF may have a positive effect after cataract surgery in high-risk groups for dry eye syndrome. ClinicalTrials.gov NCT06555224.

Myopia has been a rising problem globally. Early-onset myopia significantly increases the risk of high myopia later in life. Despite the proven benefits of increased outdoor time, optimal strategies for preventing early-onset myopia in premyopic children need further investigation. This randomized controlled trial aims to evaluate the efficacy of optical (Defocus Incorporated Multiple Segments [DIMS] spectacle lenses) and pharmacological (0.01% atropine eye drops) interventions in preventing myopia among premyopic preschoolers. We will recruit 234 premyopic, asymptomatic 5-to-6-year-old children who will have received cycloplegic autorefraction examination in a countywide kindergarten eye care program in Yilan County, Taiwan. Eligible participants will be randomly assigned to DIMS spectacles (n = 78), 0.01% atropine (n = 78), or usual care (n = 78). In the DIMS group, preschoolers will be instructed to wear spectacles at home before entering elementary school but to wear them all the time after school entry. In the atropine group, subjects will be given 0.01% atropine eyedrops nightly throughout the study period. All participants will be encouraged to spend time outdoors for 2 hours every day. During the 18-month study period, cycloplegic spherical equivalent (SE) refraction, axial length, and subfoveal choroidal thickness will be measured every three months, and parents-administered questionnaires regarding risk factors for myopia will be performed every nine months. The change in mean cycloplegic SE. The cumulative percentage of incident myopia, the cumulative percentage of a fast myopic shift of SE, and the changes in mean axial length. The time to myopia onset, alteration in subfoveal choroidal thickness, and levels of near work/outdoor activities. This study is registered at www.clinicaltrials.gov as NCT06200194. This trial will provide insights into myopia prevention strategies and inform new eye care policies for early identification and intervention in premyopic preschoolers.

Dry eye disease (DED) is a common ocular surface disorder. Esculin and digitalis possess anti-inflammatory and anti-oxidant properties, which may benefit patients with DED. This study aimed to assess the therapeutic efficacy of esculin and digitalis glycosides (EAD) eye drops, either alone or in combination with 0.3% sodium hyaluronate (SH) eye drops, in treating DED. In this randomized controlled trial, 78 participants with DED (78 eyes) were included and divided into three groups: Group A received 0.3% SH, Group B received EAD, and Group C received 0.3% SH combined with EAD eye drops for 4 weeks. The efficacy of the treatments was assessed at 2 and 4 weeks using the Ocular Surface Disease Index (OSDI), tear break-up time (TBUT), Schirmer I test (SIt), and corneal fluorescein staining (CFS) as primary evaluation metrics. After 4 weeks of treatment, Group A showed a decrease in OSDI and an increase in SIT ( p  < 0.05). Group B showed a decrease in OSDI score ( P  < 0.05) and a significant improvement in SIt ( P  < 0.01). Group C demonstrated a significant increase in both TBUT and SIt values at the 2-week mark. Improvements were noted across all parameters, including OSDI score, TBUT, SIt, and CFS score after 4 weeks of treatment ( P  < 0.05). The total effective rate for participants in Group C was 88.46%, significantly higher than Group A’s rate of 65.38% ( P  < 0.05). In conclusion, the combination of EAD eye drops with 0.3% SH eye drops proved more effective than either treatment alone.

Aims To compare the efficacy and safety of 3% diquafosol ophthalmic solution with those of 0.1% sodium hyaluronate ophthalmic solution in dry eye patients, using mean changes in fluorescein and rose bengal staining scores as endpoints. Trial design and methods In this multicenter, randomised, double-masked, parallel study of 286 dry eye patients with fluorescein and rose bengal staining scores of ≥3 were randomised to the treatment groups in a 1 : 1 ratio. Efficacy and safety were evaluated after drop-wise instillation of the study drug, six times daily for 4 weeks. Results After 4 weeks, the intergroup difference in the mean change from baseline in fluorescein staining score was −0.03; this verified the non-inferiority of diquafosol. The mean change from baseline in rose bengal staining score was significantly lower in the diquafosol group (p=0.010), thus verifying its superiority. The incidence of adverse events was 26.4% and 18.9% in the diquafosol and sodium hyaluronate groups, respectively, with no significant difference. Conclusions Diquafosol (3%) and sodium hyaluronate (0.1%) exhibit similar efficacy in improving fluorescein staining scores of dry eye patients, whereas, diquafosol exhibits superior efficacy in improving rose bengal staining scores. Diquafosol has high clinical efficacy and is well tolerated with a good safety profile.

To compare the efficacy of a 0.15% HA with that of 0.1% HA eye drops for DES after cataract surgery. This study was double blinded, randomized and prospective study, and conducted in 69 participants (70 eyes) from Pusan National University Yangsan Hospital and executed from February 1, 2022 to November 30, 2022. Participants were adult cataract patients with normal lid position, not suffering from any other ocular disease and not meet the exclusion cirteria of clinical trial. Participants were randomly divided into two groups: 35 participants (17 males and 18 females) in the 0.1% HA group and 34 participants (19 males and 15 females) in the 0.15% HA group, receiving treatment six times daily for 6 weeks following cataract surgery. Subjective and objective assessments were performed at preoperative and postoperative visits, including ocular surface disease index score, tear break up time, corneal staining score, Schirmer's I test score, lipid layer thickness), meiboscore, and biochemical analysis of the eye drops. Throughout the study, the postoperative ocular surface disease index score was significantly lower in the group receiving 0.15% hyaluronic acid than in the group receiving 0.1% hyaluronic acid. Additionally, the postoperative ocular surface disease index score showed a significant positive correlation with the postoperative use of 0.15% hyaluronic acid and the preoperative Schirmer's I test score. In multivariate analysis, treatment with 0.15% hyaluronic acid and the preoperative ocular surface disease index score were significant independent parameters affecting the postoperative ocular surface disease index score. The use of 0.15% hyaluronic acid is recommended for its potential advantages in alleviating symptoms following cataract surgery, making it a viable alternative to traditional 0.1% hyaluronic acid treatment. ISRCTN95830348.

Various methods can correct presbyopia, but all require devices or surgeries. Recently, supplements or warming devices to relieve presbyopic symptoms have been developed, but no eye drops have been developed. We screened certain compounds possibly related to lens degeneration and identified pirenoxine, which has been used for cataracts, as a possible new pharmacologic treatment for presbyopia. We first researched the anti-presbyopic activity of pirenoxine in rats. The lens elasticity significantly ( p  = 0.028) increased with exposure to tobacco smoke for 12 days, and pirenoxine eye drops significantly ( p  < 0.001) suppressed lens hardening, which causes presbyopia in humans. In a parallel randomized controlled clinical study of the subjects in their fifth decade of life, the objective accommodative amplitude (AA) decreased significantly ( p  < 0.01) by 0.16 diopter (D) in the control group, and there was no detectable change in the treatment group after a 6-month treatment period, suggesting that pirenoxine eye drops might prevent progression of presbyopia. Subjects in their sixth decade of life, in whom the AA was already nearly 0 D, did not show similar results. Pirenoxine eye drops might be a new and the first pharmacologic treatment for preventing progression of presbyopia.

•This study was necessitated to bridge this knowledge gap by systematically evaluating the effect of timolol in the sequential treatment of angle-closure crisis (AACC), aiming to provide clearer guidance for clinical treatment.•This study clarifies that timolol eye drops do not significantly enhance the success rate of AACC sequential treatment compared to placebo.•This study prompts a re-evaluation of treatment protocols for AACC, suggesting that reliance on timolol eye drops may need revision.•It highlights the potential for research into more effective treatments and could lead to changes in clinical practice, steering toward multimodal treatment strategies. To observe and compare the efficacy of timolol eye drops in sequential treatment of acute angle-closure crisis (AACC). In this prospective, randomized, double-blind case-control study, patients diagnosed with AACC at the Affiliated Hospital of Hebei University from April 2021 to October 2023 were continuously enrolled. The patient data were collected and randomly divided into timolol group (group A) and placebo group (group B). All patients were sequentially treated with drug therapy, anterior chamber paracentesis, and argon laser peripheral iridoplasty. The primary outcomes were decreased intraocular pressure (IOP), success rate, and treatment time. At 2 hours, 4 hours, and 6 hours after the start of treatment, the reduction in IOP in group A was 13.87 ± 13.85 mm Hg, 28.42 ± 12.87 mm Hg, and 35.69 ± 8.51 mm Hg, respectively, and the number of controlled eyes was 23 (29.87%), 51 (66.23%), and 71 (92.20%), respectively. The reduction in IOP in group B was 15.88 ± 14.95 mm Hg, 28.17 ± 13.63 mm Hg, and 33.90 ± 13.59 mm Hg, respectively, and the number of controlled eyes was 30 (36.59%), 58 (70.73%), and 75 (91.46%) eyes, respectively. Among patients whose crises were relieved, the times for AACC relief were 3.29 ± 1.31 hours in group A and 3.38 ± 1.34 hours in group B. There were no significant differences in IOP reduction, numbers of eyes remission, and times for AACC relief between the 2 groups at each point of sequential treatment (P > 0.05). In the sequential treatment of AACC, timolol is not helpful to improve the success rate of treatment.