Mark Schaeffer, Ayda Shahidi, Gary Mosehauer, Marjorie Rah, William Reindel
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引用次数: 0
Abstract
Introduction: Planned replacement soft contact lenses (PRSCLs) continue to remain a popular option for vision correction. Biotrue Hydration Plus (BHP) is a novel multipurpose solution (MPS) developed for PRSCLs, with a formulation informed by Tear Film & Ocular Surface Society (TFOS) International Dry Eye Workshop II insights. It contains hyaluronan (HA) for moisturizing, erythritol for antioxidant and osmoprotectant properties, and potassium to support ocular homeostasis. It also incorporates poloxamine 1107 and poloxamer 181 surfactants for lens cleaning and wettability, alongside a triple disinfectant system. A two-arm study evaluated the clinical performance of BHP MPS over 3 months; here, we present a subanalysis of the BHP MPS arm.
Methods: This study was conducted across 17 sites in the USA, with evaluations at 2 weeks, 1 month, 2 months, and 3 months of lens wear. BHP MPS was dispensed to habitual wearers of silicone hydrogel or conventional hydrogel PRSCLs (four and one prespecified types, respectively). Subjects rated 13 lens performance attributes (grouped into comfort, vision, handling, lens cleanliness, and overall impression). Performance ratings were compared across visits using statistical methods to confirm consistency and equivalence. Investigators performed slit lamp examinations and evaluated lens deposits at each follow-up visit to assess MPS biocompatibility.
Results: Mean scores for lens comfort, vision, handling, and cleanliness on removal, and also overall impression, were 80-100 across all visits (very good-excellent; p ≥ 0.05). No subject presented with > Grade 2 slit lamp findings at any visit, and few ungraded slit lamp findings were noted, reflecting the biocompatibility of BHP MPS with respect to the ocular surface. Lens deposition, cleanliness, and wettability were clinically acceptable in almost all subjects, and no participants discontinued owing to an adverse event.
Conclusions: In this analysis, BHP MPS was associated with minimal lens deposition, excellent biocompatibility, and high-performance ratings, making it a promising option for PRSCL wearers and for eye care practitioners to recommend before switching symptomatic wearers to a different contact lens modality.
期刊介绍：
Aims and Scope
Ophthalmology and Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from preclinical, clinical (all phases), observational, real-world, and health outcomes research around the use of ophthalmological therapies, devices, and surgical techniques.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Ophthalmology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals.
Rapid Publication
The journal’s publication timelines aim for a rapid peer review of 2 weeks. If an article is accepted it will be published 3–4 weeks from acceptance. The rapid timelines are achieved through the combination of a dedicated in-house editorial team, who manage article workflow, and an extensive Editorial and Advisory Board who assist with peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid, efficient communication of the latest research and reviews, fostering the advancement of ophthalmic therapies.
Open Access
All articles published by Ophthalmology and Therapy are open access.
Personal Service
The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning authors will always have an editorial contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research.
Digital Features and Plain Language Summaries
Ophthalmology and Therapy offers a range of additional features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by key summary points, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand the scientific content and overall implications of the article. The journal also provides the option to include various types of digital features including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations. All additional features are peer reviewed to the same high standard as the article itself. If you consider that your paper would benefit from the inclusion of a digital feature, please let us know. Our editorial team are able to create high-quality slide decks and infographics in-house, and video abstracts through our partner Research Square, and would be happy to assist in any way we can. For further information about digital features, please contact the journal editor (see ‘Contact the Journal’ for email address), and see the ‘Guidelines for digital features and plain language summaries’ document under ‘Submission guidelines’.
For examples of digital features please visit our showcase page https://springerhealthcare.com/expertise/publishing-digital-features/
Publication Fees
Upon acceptance of an article, authors will be required to pay the mandatory Rapid Service Fee of €5250/$6000/£4300. The journal will consider fee discounts and waivers for developing countries and this is decided on a case by case basis.
Peer Review Process
Upon submission, manuscripts are assessed by the editorial team to ensure they fit within the aims and scope of the journal and are also checked for plagiarism. All suitable submissions are then subject to a comprehensive single-blind peer review. Reviewers are selected based on their relevant expertise and publication history in the subject area. The journal has an extensive pool of editorial and advisory board members who have been selected to assist with peer review based on the afore-mentioned criteria.
At least two extensive reviews are required to make the editorial decision, with the exception of some article types such as Commentaries, Editorials, and Letters which are generally reviewed by one member of the Editorial Board. Where reviewer recommendations are conflicted, the editorial board will be contacted for further advice and a presiding decision. Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed). Once a revised manuscript is re-submitted, it is assessed along with the responses to reviewer comments and if it has been adequately revised it will be accepted for publication. Accepted manuscripts are then copyedited and typeset by the production team before online publication. Appeals against decisions following peer review are considered on a case-by-case basis and should be sent to the journal editor.
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