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Drugs Apr 2024Perfluorohexyloctane ophthalmic solution (Miebo) is a single-entity, water-, steroid- and preservative-free, first-in-class semifluorinated alkane that is approved in... (Review)
Review
Perfluorohexyloctane ophthalmic solution (Miebo) is a single-entity, water-, steroid- and preservative-free, first-in-class semifluorinated alkane that is approved in the USA for the treatment of the signs and symptoms of dry eye disease (DED). DED is often linked with meibomian gland dysfunction (MGD), which causes an excessive evaporation of tears. Perfluorohexyloctane ophthalmic solution stabilizes the lipid layer of the tear film and inhibits tear evaporation by forming a monolayer at the air-liquid interface. In the phase III GOBI and MOJAVE trials in adults with DED associated with MGD, one drop of perfluorohexyloctane ophthalmic solution instilled in each eye four times daily over 8 weeks resulted in statistically significant and clinically meaningful improvements in the signs and symptoms of DED compared with hypotonic saline (0.6%). The agent was generally well tolerated, with most ocular adverse events being mild or moderate in severity. The efficacy and tolerability of perfluorohexyloctane ophthalmic solution was sustained for up to 52 weeks in an extension study (KALAHARI). As the first and currently the only prescription treatment approved in the USA directly addressing the pathophysiology of excessive tear evaporation, perfluorohexyloctane ophthalmic solution is a valuable emerging option for the management of DED.
Topics: Humans; Ophthalmic Solutions; Fluorocarbons; Dry Eye Syndromes
PubMed: 38554243
DOI: 10.1007/s40265-024-02016-5 -
Survey of Ophthalmology 2024Vernal keratoconjunctivitis (VKC) is a chronic, progressive, and potentially sight-threatening form of ocular inflammatory disease that primarily affects children and... (Review)
Review
Vernal keratoconjunctivitis (VKC) is a chronic, progressive, and potentially sight-threatening form of ocular inflammatory disease that primarily affects children and young adults. Prevalence varies by region, ranging from <2 per 10,000 in the United States to as high as 1,100 per 10,000 in parts of Africa. The rarity of VKC in developed countries can make differential diagnosis challenging, and treatment is often delayed until the disease is advanced, and symptoms are significantly impacting patients' quality of life. Although once viewed primarily as an immunoglobulin E-mediated condition, approximately 50% of patients with VKC do not exhibit allergic sensitization. It is now recognized that the immunopathology of VKC involves multiple inflammatory pathways that lead to the signs, symptoms, and conjunctival eosinophilic and fibroproliferative lesions that are a hallmark of the disease. We examine the evolution of our understanding of the immunopathology of VKC, the expanding VKC treatment armamentarium, the clinical implications of emerging treatment approaches, and future directions for VKC research and practice.
Topics: Child; Humans; Conjunctivitis, Allergic; Cyclosporine; Quality of Life; Conjunctiva; Ophthalmic Solutions
PubMed: 37890678
DOI: 10.1016/j.survophthal.2023.10.008 -
Eye & Contact Lens Dec 2023Although the ultimate goal of dry eye disease (DED) management is to restore the ocular surface and tear film homeostasis and address any accompanying symptoms,... (Review)
Review
Although the ultimate goal of dry eye disease (DED) management is to restore the ocular surface and tear film homeostasis and address any accompanying symptoms, addressing this is not an easy task. Despite the wide range of current treatment modalities targeting multiple aspects of DED, the available DED management literature is quite heterogeneous, rendering evaluation or comparison of treatment outcomes hard or almost impossible. There is still a shortage of well-designed, large-scale, nonsponsored, randomized, controlled trials (RCTs) evaluating long-term safety and efficacy of many targeted therapies individually or used in combination, in the treatment of identified subgroups of patients with DED. This review focuses on the treatment modalities in DED management and aims to reveal the current evidence available as deduced from the outcomes of RCTs.
Topics: Humans; Randomized Controlled Trials as Topic; Dry Eye Syndromes; Eye; Lubricant Eye Drops; Tears
PubMed: 37728883
DOI: 10.1097/ICL.0000000000001026 -
Journal of Artificial Organs : the... Jun 2024Excessive albumin losses during HC (haemocatharsis) are considered a potential cause of hypoalbuminemia-a key risk factor for mortality. This review on total albumin... (Review)
Review
Excessive albumin losses during HC (haemocatharsis) are considered a potential cause of hypoalbuminemia-a key risk factor for mortality. This review on total albumin losses considers albumin "leaking" into the dialysate and losses due to protein/membrane interactions (i.e. adsorption, "secondary membrane formation" and denaturation). The former are fairly easy to determine, usually varying at the level of ~ 2 g to ~ 7 g albumin loss per session. Such values, commonly accepted as representative of the total albumin losses, are often quoted as limits/standards of permissible albumin loss per session. On albumin mass lost due to adsorption/deposition, which is the result of complicated interactions and rather difficult to determine, scant in vivo data exist and there is great uncertainty and confusion regarding their magnitude; this is possibly responsible for neglecting their contribution to the total losses at present. Yet, many relevant in vitro studies suggest that losses of albumin due to protein/membrane interactions are likely comparable to (or even greater than) those due to leaking, particularly in the currently favoured high-convection HDF (haemodiafiltration) treatment. Therefore, it is emphasised that top research priority should be given to resolve these issues, primarily by developing appropriate/facile in vivo test-methods and related analytical techniques.
Topics: Humans; Dialysis Solutions; Hemodiafiltration; Hypoalbuminemia; Renal Dialysis; Serum Albumin
PubMed: 38238597
DOI: 10.1007/s10047-023-01430-y -
Zhongguo Zhen Jiu = Chinese Acupuncture... Sep 2023To compare the clinical efficacy and safety of acupuncture and sodium hyaluronate eye drop in the treatment of aqueous deficiency dry eye. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES
To compare the clinical efficacy and safety of acupuncture and sodium hyaluronate eye drop in the treatment of aqueous deficiency dry eye.
METHODS
A total of 60 patients (120 eyes) with aqueous deficiency dry eye were randomly divided into an observation group (30 cases, 1 case dropped out) and a control group (30 cases, 1 case dropped out). In the control group, sodium hyaluronate eye drop were used, one drop at a time, 4 times a day, for 14 consecutive days. In the observation group, acupuncture was applied at bilateral Shangjingming (Extra), Cuanzhu (BL 2), Sizhukong (TE 23), Taiyang (EX-HN 5), and Tongziliao (GB 1) , once a day, treatment for 6 days with the interval of 1 day was required, for 14 consecutive days. The tear meniscus height (TMH), Schirmer Ⅰ test (SⅠT), ocular surface disease index (OSDI) score, non-invasive tear break-up time (NIBUT), and corneal fluorescein sodium staining (FLS) score were compared between the two groups before and after treatment, and the safety of the treatment of the two groups was observed.
RESULTS
Compared with those before treatment, after treatment, TMH, SⅠT and NIBUT were increased (<0.01, <0.05), and FLS scores were decreased (<0.01) in the two groups; the score of OSDI was reduced (<0.01) in the observation group. After treatment, in the observation group, TMH and SⅠT were higher than those in the control group (<0.01), and the score of OSDI was lower than that in the control group (<0.01). No adverse reactions and adverse events were observed in the two groups.
CONCLUSIONS
Acupuncture and sodium hyaluronate eye drop can both effectively treat aqueous deficiency dry eye, acupuncture has obvious advantages in improving TMH and basic tear secretion, and reducing the subjective symptoms of patients. Acupuncture for dry eye is safe.
Topics: Humans; Hyaluronic Acid; Acupuncture Therapy; Dry Eye Syndromes; Eye; Tears; Ophthalmic Solutions; Fluorescein
PubMed: 37986246
DOI: 10.13703/j.0255-2930.20230407-k0006 -
Pediatric Nephrology (Berlin, Germany) Dec 2023The risk of cardiovascular disease remains exceedingly high in pediatric patients with chronic kidney disease stage 5 on dialysis (CKD 5D). Sodium (Na) overload is a... (Review)
Review
The risk of cardiovascular disease remains exceedingly high in pediatric patients with chronic kidney disease stage 5 on dialysis (CKD 5D). Sodium (Na) overload is a major cardiovascular risk factor in this population, both through volume-dependent and volume-independent toxicity. Given that compliance with a Na-restricted diet is generally limited and urinary Na excretion impaired in CKD 5D, dialytic Na removal is critical to reduce Na overload. On the other hand, an excessive or too fast intradialytic Na removal may lead to volume depletion, hypotension, and organ hypoperfusion. This review presents current knowledge on intradialytic Na handling and possible strategies to optimize dialytic Na removal in pediatric patients on hemodialysis (HD) and peritoneal dialysis (PD). There is increasing evidence supporting the prescription of lower dialysate Na in salt-overloaded children on HD, while improved Na removal may be achieved in children on PD with an individual adaptation of dwell time and volume and with icodextrin use during the long dwell.
Topics: Humans; Child; Renal Dialysis; Sodium; Peritoneal Dialysis; Dialysis Solutions; Kidney Failure, Chronic
PubMed: 37148342
DOI: 10.1007/s00467-023-05999-7 -
Optometry and Vision Science : Official... Aug 2023Low-dose atropine is one of the leading treatments of myopia progression in children. However, the effect of low-dose atropine on binocular vision measurements has not... (Randomized Controlled Trial)
Randomized Controlled Trial
SIGNIFICANCE
Low-dose atropine is one of the leading treatments of myopia progression in children. However, the effect of low-dose atropine on binocular vision measurements has not been thoroughly studied.
PURPOSE
This study aimed to determine the effect of 0.01, 0.03, and 0.05% atropine on visual acuity, pupil size, binocular vision, and accommodation in children aged 6 to 17 years.
METHODS
Forty-six children (28 girls and 18 boys) were randomized into four groups: placebo (n = 10) and 0.01% (n = 13), 0.03% (n = 11), and 0.05% (n = 12) atropine. One drop of atropine or placebo was administered into each eye once. The following measurements were collected before applying the eye drops and 30 minutes, 60 minutes, and 24 hours after application of eye drops: habitual visual acuity at distance and near, pupil size, dissociated phoria at distance and near, negative and positive fusional vergence, near point convergence, near point convergence stamina and fragility, accommodative lag, and amplitude of accommodation. Repeated-measures analysis of variance was used, and P < .05 was considered statistically significant.
RESULTS
Differences in pupil diameters under photopic and scotopic conditions were statistically significant when comparing all three atropine groups with placebo over time ( P < .001). Pupil size in both the 0.03 and 0.05% atropine groups was enlarged from baseline at the 30-minute, 60-minute, and 24-hour time points ( P < .05) in both photopic and scotopic conditions. Pupil size in the 0.01% atropine group had minimal change, and only the scotopic 60-minute time point was statistically significant ( P = .02). All three concentrations of atropine eye drops have no significant effect on accommodation, binocular vision measurements, or visual acuity compared with the control group.
CONCLUSIONS
Pupil size was significantly enlarged by 0.03 and 0.05% atropine in both photopic and scotopic conditions. Low-dose atropine eye drops have no significant effect on accommodation, binocular vision measurements, or visual acuity compared with control.
Topics: Male; Female; Humans; Child; Atropine; Vision, Binocular; Visual Acuity; Accommodation, Ocular; Ophthalmic Solutions
PubMed: 37278695
DOI: 10.1097/OPX.0000000000002031 -
The New England Journal of Medicine Apr 2024Most moderate-to-late-preterm infants need nutritional support until they are feeding exclusively on their mother's breast milk. Evidence to guide nutrition strategies... (Randomized Controlled Trial)
Randomized Controlled Trial Comparative Study
BACKGROUND
Most moderate-to-late-preterm infants need nutritional support until they are feeding exclusively on their mother's breast milk. Evidence to guide nutrition strategies for these infants is lacking.
METHODS
We conducted a multicenter, factorial, randomized trial involving infants born at 32 weeks 0 days' to 35 weeks 6 days' gestation who had intravenous access and whose mothers intended to breast-feed. Each infant was assigned to three interventions or their comparators: intravenous amino acid solution (parenteral nutrition) or dextrose solution until full feeding with milk was established; milk supplement given when maternal milk was insufficient or mother's breast milk exclusively with no supplementation; and taste and smell exposure before gastric-tube feeding or no taste and smell exposure. The primary outcome for the parenteral nutrition and the milk supplement interventions was the body-fat percentage at 4 months of corrected gestational age, and the primary outcome for the taste and smell intervention was the time to full enteral feeding (150 ml per kilogram of body weight per day or exclusive breast-feeding).
RESULTS
A total of 532 infants (291 boys [55%]) were included in the trial. The mean (±SD) body-fat percentage at 4 months was similar among the infants who received parenteral nutrition and those who received dextrose solution (26.0±5.4% vs. 26.2±5.2%; adjusted mean difference, -0.20; 95% confidence interval [CI], -1.32 to 0.92; P = 0.72) and among the infants who received milk supplement and those who received mother's breast milk exclusively (26.3±5.3% vs. 25.8±5.4%; adjusted mean difference, 0.65; 95% CI, -0.45 to 1.74; P = 0.25). The time to full enteral feeding was similar among the infants who were exposed to taste and smell and those who were not (5.8±1.5 vs. 5.7±1.9 days; P = 0.59). Secondary outcomes were similar across interventions. Serious adverse events occurred in one infant.
CONCLUSIONS
This trial of routine nutrition interventions to support moderate-to-late-preterm infants until full nutrition with mother's breast milk was possible did not show any effects on the time to full enteral feeding or on body composition at 4 months of corrected gestational age. (Funded by the Health Research Council of New Zealand and others; DIAMOND Australian New Zealand Clinical Trials Registry number, ACTRN12616001199404.).
Topics: Female; Humans; Infant; Infant, Newborn; Male; Amino Acids; Breast Feeding; Enteral Nutrition; Gestational Age; Glucose; Infant, Premature; Milk, Human; Parenteral Nutrition; Smell; Taste; Nutritional Support; Parenteral Nutrition Solutions; Adiposity
PubMed: 38657245
DOI: 10.1056/NEJMoa2313942 -
Ophthalmology Jan 2024To review the current published literature for high-quality studies on the use of selective laser trabeculoplasty (SLT) for the treatment of glaucoma. This is an update... (Review)
Review
PURPOSE
To review the current published literature for high-quality studies on the use of selective laser trabeculoplasty (SLT) for the treatment of glaucoma. This is an update of the Ophthalmic Technology Assessment titled, "Laser Trabeculoplasty for Open-Angle Glaucoma," published in November 2011.
METHODS
Literature searches in the PubMed database in March 2020, September 2021, August 2022, and March 2023 yielded 110 articles. The abstracts of these articles were examined to include those written since November 2011 and to exclude reviews and non-English articles. The panel reviewed 47 articles in full text, and 30 were found to fit the inclusion criteria. The panel methodologist assigned a level I rating to 19 studies and a level II rating to 11 studies.
RESULTS
Data in the level I studies support the long-term effectiveness of SLT as primary treatment or as a supplemental therapy to glaucoma medications for patients with open-angle glaucoma. Several level I studies also found that SLT and argon laser trabeculoplasty (ALT) are equivalent in terms of safety and long-term efficacy. Level I evidence indicates that perioperative corticosteroid and nonsteroidal anti-inflammatory drug eye drops do not hinder the intraocular pressure (IOP)-lowering effect of SLT treatment. The impact of these eye drops on lowering IOP differed in various studies. No level I or II studies exist that determine the ideal power settings for SLT.
CONCLUSIONS
Based on level I evidence, SLT is an effective long-term option for the treatment of open-angle glaucoma and is equivalent to ALT. It can be used as either a primary intervention, a replacement for medication, or an additional therapy with glaucoma medications.
FINANCIAL DISCLOSURE(S)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Topics: Humans; Glaucoma; Glaucoma, Open-Angle; Lasers; Ophthalmic Solutions; Ophthalmology; Trabecular Meshwork; Trabeculectomy; United States
PubMed: 37702635
DOI: 10.1016/j.ophtha.2023.07.029 -
Journal of Controlled Release :... Aug 2023Corneal neovascularization (CNV) badly damages the corneal transparency, resulting in visual disturbance and blindness. The frequent administration of glucocorticoid eye...
Corneal neovascularization (CNV) badly damages the corneal transparency, resulting in visual disturbance and blindness. The frequent administration of glucocorticoid eye drops in clinical increases the possibility of side effects and reduces patient compliance. Considering CNV is often accompanied by an increase in ROS production, a ROS-responsive monomer 2-(methylthio)ethyl methacrylate was introduced into the matrix as a "gating switch". The prepared dexamethasone contact lenses (MCLs@Dex) showed a significant HO-responsive release for 168 h. To avoid corneal hypoxia and neovascularization caused by long-term wearing, high‑oxygen-permeability fluorosiloxane materials were incorporated. The oxygen permeability of MCLs@Dex was 4 times that of commercially available hydrogel contact lenses and had ultra-low protein adsorption, which meets the requirements of long-term wearing. In vivo pharmacokinetic studies showed that MCLs@Dex increased the mean residence time by 19.7 times and bioavailability by 2.29 times compared with eye drops, validating the ROS response and sustained release properties. More importantly, MCLs@Dex had satisfactory effects on reducing inflammation and decreasing the related cytokines and oxidative stress levels, and demonstrated significant inhibition of neovascularization, with a suppression rate of 76.53% on the 14th day. This responsive drug delivery system provides a promising new method for the safe and effective treatment of ocular surface diseases.
Topics: Humans; Adult; Corneal Neovascularization; Hydrogen Peroxide; Reactive Oxygen Species; Contact Lenses; Inflammation; Oxygen; Ophthalmic Solutions
PubMed: 37481212
DOI: 10.1016/j.jconrel.2023.07.036