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Efficacy and safety of a multi-action tear substitute based on 0.15% cross-linked hyaluronic acid, 3% trehalose and liposomes with stearylamine: A randomized, single-mask, controlled study
Purpose
To evaluate the efficacy and safety of TriMix, a new multiple-action tear substitute in patients with dry eye disease (DED).
Methods
This was a randomized, multicenter, single-masked, hyaluronic acid (HA)-controlled clinical trial conducted between July, 2023 and May, 2024. A total of 115 patients were randomly allocated to receive either TriMix tear substitute or 0.15% HA tear substitute 3 times daily. Clinical outcomes include ocular surface disease index (OSDI) questionnaire, non-invasive tear film break-up time (NIBUT) and Schirmer I test (ST) without anesthesia at 3 and 6 months of follow-up.
Results
Of the 115 patients randomized, 80 completed the study (TriMix,
n
= 56; HA,
n
= 24). At months 3 and 6, improvements from baseline were statistically greater with TriMix tear substitute compared to HA 0.15% tear substitute for OSDI: -3.7 points (95% CI, -6.9 to -0.6;
p
= 0.011) and − 7.5 points (95% CI, -10.3 to -4.6;
p
< 0.001), respectively. Similar results were reported for NIBUT: 0.9 s (95% CI, 0.3 to 1.6;
P
= 0.040) and 1.6 s (95% CI, 0.7 to 2.6;
P
< 0.001), respectively. Regarding safety, no serious ocular adverse events occurred. Three patients complained of burning after instillation of TriMix tear substitute.
Conclusion
This RCTs demonstrate that TriMix tear substitute provides statistically significant and clinically evidence of the reduction of DED symptoms with a satisfactory safety profile through 6 months of follow-up. Findings suggest the use of this tear substitute, but results should be confirmed independently over longer time periods.
Key messages
What is known
Given the high prevalence and significant impact of DED on patients’ quality of life, developing effective treatments is crucial. Among the various therapeutic options, tear substitutes remain the first step in the treatment of DED.
The study was conducted to evaluate the efficacy and safety of TriMix, a new multiple-action tear substitute, in patients with DED.
New information
The study found that the instillation of TriMix tear substitute 3 times daily significantly improved DED symptoms and signs, with rapid efficacy and a satisfactory safety profile over a 6-month follow-up period
Journal Article
The Effect of Lutein on Eye and Extra-Eye Health
Lutein is a carotenoid with reported anti-inflammatory properties. A large body of evidence shows that lutein has several beneficial effects, especially on eye health. In particular, lutein is known to improve or even prevent age-related macular disease which is the leading cause of blindness and vision impairment. Furthermore, many studies have reported that lutein may also have positive effects in different clinical conditions, thus ameliorating cognitive function, decreasing the risk of cancer, and improving measures of cardiovascular health. At present, the available data have been obtained from both observational studies investigating lutein intake with food, and a few intervention trials assessing the efficacy of lutein supplementation. In general, sustained lutein consumption, either through diet or supplementation, may contribute to reducing the burden of several chronic diseases. However, there are also conflicting data concerning lutein efficacy in inducing favorable effects on human health and there are no univocal data concerning the most appropriate dosage for daily lutein supplementation. Therefore, based on the most recent findings, this review will focus on lutein properties, dietary sources, usual intake, efficacy in human health, and toxicity.
Journal Article
Dry Eye
Dry eye is a common, painful ocular disturbance that can result from systemic inflammatory diseases, localized eye problems, or commonly used medications. Current treatments address symptoms, but advances in understanding tear-film function may lead to new approaches.
Journal Article
Primary care of the anterior segment
This reference has been expanded to include information on corneal immunology, lasers and general information on the approach to the patient with anterior segment disease. The SOAP (subjective, objective, assessment and plan) narrative has been expanded.
Book
Defining Dry Eye from a Clinical Perspective
Over the past decades, the number of patients with dry eye disease (DED) has increased dramatically. The incidence of DED is higher in Asia than in Europe and North America, suggesting the involvement of cultural or racial factors in DED etiology. Although many definitions of DED have been used, discrepancies exist between the various definitions of dry eye disease (DED) used across the globe. This article presents a clinical consensus on the definition of DED, as formulated in four meetings with global DED experts. The proposed new definition is as follows: “Dry eye is a multifactorial disease characterized by a persistently unstable and/or deficient tear film (TF) causing discomfort and/or visual impairment, accompanied by variable degrees of ocular surface epitheliopathy, inflammation and neurosensory abnormalities.” The key criteria for the diagnosis of DED are unstable TF, inflammation, ocular discomfort and visual impairment. This definition also recommends the assessment of ocular surface epitheliopathy and neurosensory abnormalities in each patient with suspected DED. It is easily applicable in clinical practice and should help practitioners diagnose DED consistently. This consensus definition of DED should also help to guide research and clinical trials that, to date, have been hampered by the lack of an established surrogate endpoint.
Journal Article
Eye to eye : how animals see the world
\"...explains how for most animals, eyes are the most important source of information about the world in a biological sense. The simplest eyes--clusters of light-sensitive cells--appeared more than one billion years ago, and provided a big survival advantage to the first creatures that had them. Since then, animals have evolved an amazing variety of eyes, along with often surprising ways to use them.\"--Amazon.com.
Book
Evaluation of umbilical cord blood serum eye drops for severe dry eye in two distinct populations-Sjögren's syndrome and mustard gas-induced ocular injury: Protocol for a pilot randomized clinical trial
Human umbilical cord blood (HUCB) serum eye drops contain growth factors, neurotrophic agents, and antimicrobial compounds that may promote ocular surface healing and regeneration. Sjögren's syndrome is a chronic autoimmune condition characterized by reduced tear production and ocular surface damage, often resulting in severe dry eye symptoms. Mustard gas chemical veterans also suffer from similar debilitating ocular complications due to chronic inflammation and meibomian gland dysfunction. While conventional treatments offer symptomatic relief, they lack essential components of natural tears.
This pilot randomized controlled trial will evaluate the efficacy of HUCB eye drops in three patient groups: (A) Sjögren's patients treated with HUCB drops, (B) Sjögren's patients receiving conventional treatment, and (C) mustard gas veterans receiving conventional treatment in the right eye and HUCB drops in the left eye. Patients will be assessed using subjective and objective tools, including the Ocular Surface Disease Index (OSDI), visual acuity, tear film breakup time (TBUT), SM tube test, and fluorescein staining based on SICCA criteria. Group allocation will follow a blocked randomization sequence for groups A and B; group C will follow a within-subject paired-eye design. Follow-up will occur at 30 and 60 days.
This study aims to assess the regenerative potential of HUCB serum in patients with autoimmune and chemically induced dry eye. Its results may support broader clinical use of HUCB drops in treating severe ocular surface disorders, including conditions like Stevens-Johnson syndrome and industrial chemical exposures.
This trial was registered at the Iranian Registry of Clinical Trials (Registration number: IRCT20230925059512N1, Registration date: 2024-08-11).
Journal Article