Jeremy Chung Bo Chiang, Mengliang Wu, Ji-Hyun Lee, Alyssa Curkpatrick, Cristos Ifantides, Thanh Nguyen, Anat Galor, Helen Wu, Richard Lindstrom, Vance Thompson, Laura E Downie
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引用次数: 0
Abstract
Introduction: A safe and effective treatment for chronic ocular surface pain (COSP) remains an unmet need. This prospective feasibility study investigated the impact of an ophthalmic cooling device (ETX-4143) on ocular pain, as well as corneal nerve and immune cell features, in individuals with COSP.
Methods: For this clinical trial (Clinicaltrials.gov:NCT07059754), the more symptomatic (study) eye was treated with the ETX-4143 device, involving two metallic probes, internally cooled by a -20 °C fluid, applied to the bulbar conjunctiva posterior to the limbus at 3 and 9 o'clock for 4 min, with a fellow (untreated) eye control. Ocular pain, best-corrected visual acuity (BCVA), tear osmolarity, corneal sensitivity, slit lamp biomicroscopy, ocular surface staining, and static and functional in vivo confocal microscopy (Fun-IVCM) were conducted at baseline and 2-, 6-, and 12-weeks posttreatment. Corneal nerve and immune cell parameters were quantified.
Results: Five eligible participants were enrolled and completed the study (mean age 66.4 ± 9.9 years, 60% female/40% male). Relative to baseline, ocular pain, measured with the Chronic Ocular Pain Questionnaire (COP-Q) Eye Pain Severity Module, was significantly lower at 2 weeks (mean change -4.4 units, 95% CI -7.4 to -1.4, P = 0.02), 6 weeks (-5.0 units, 95% CI -7.0 to -3.0, P = 0.002), and 12 weeks posttreatment (-5.8 units, 95% CI -7.8 to -3.8, P = 0.001); benefit progressed with time. Clinical ocular surface signs, BCVA, and corneal nerve morphology remained stable. In the study eye, corneal Fun-IVCM showed an increase in putative intraepithelial T-cell motility up to 6 weeks posttreatment (P < 0.001), followed by a reduction at 12 weeks (P = 0.03) that was accompanied by reduced probing of putative dendritic cells (P = 0.049), relative to baseline.
Conclusions: The ETX-4143 device showed a favorable safety profile, including preserved corneal nerve morphology, while improving pain outcomes and modulating corneal immune dynamics up to 12 weeks posttreatment, acknowledging these findings are exploratory. Randomized controlled trials are warranted to evaluate treatment efficacy and mechanisms.
一种安全有效的治疗慢性眼表痛（COSP）的方法仍然是一个未满足的需求。这项前瞻性可行性研究调查了眼冷却装置（ETX-4143）对COSP患者眼部疼痛以及角膜神经和免疫细胞特征的影响。方法：在本临床试验（Clinicaltrials.gov:NCT07059754）中，使用ETX-4143装置治疗较有症状的（研究）眼，包括两个金属探针，用-20°C液体内部冷却，在3点和9点将其应用于角膜缘后的球结膜，持续4分钟，同时使用另一个（未经治疗的）眼睛对照。眼部疼痛、最佳矫正视力（BCVA）、泪液渗透压、角膜敏感性、裂隙灯生物显微镜、眼表染色、静态和功能性体内共聚焦显微镜（funivcm）分别在基线和治疗后2周、6周和12周进行。定量测定角膜神经和免疫细胞参数。结果：5名符合条件的受试者入组并完成研究（平均年龄66.4±9.9岁，女性占60% /男性占40%）。与基线相比，用慢性眼痛问卷（COP-Q）眼痛严重程度模块测量的眼痛在治疗后2周（平均变化-4.4个单位，95% CI -7.4至-1.4,P = 0.02）、6周（-5.0个单位，95% CI -7.0至-3.0,P = 0.002）和12周（-5.8个单位，95% CI -7.8至-3.8,P = 0.001）显著降低；福利随着时间的推移而增加。临床眼表体征、BCVA、角膜神经形态保持稳定。结论：ETX-4143装置显示出良好的安全性，包括保存了角膜神经形态，同时改善了疼痛结局，并调节了治疗后12周的角膜免疫动力学，承认这些发现是探索性的。需要随机对照试验来评估治疗效果和机制。试验注册：ClinicalTrials.gov识别码，NCT07059754。
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/
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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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For more information about the journal, including pre-submission enquiries, please contact christopher.vautrinot@springer.com.
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