Anat Galor, Bonnie Henderson, Cristos Ifantides, James A Stefater, Tomasz P Stryjewski
{"title":"The Safety and Tolerability of a Single Scleral Treatment With a Cooling Device in Rabbits.","authors":"Anat Galor, Bonnie Henderson, Cristos Ifantides, James A Stefater, Tomasz P Stryjewski","doi":"10.1167/tvst.14.10.2","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the preclinical safety of a single treatment of a topical scleral cooling device.</p><p><strong>Methods: </strong>Two Good Laboratory Practice prospective preclinical device safety studies were performed: study 1 in normal healthy rabbit eyes (n = 5) and study 2 in healthy rabbit eyes that underwent a surgically induced corneal epithelial defect (n = 3). Following sedation, eyes were treated for 10 minutes by applying the cooling device to the sclera. Key assessments for both studies included clinical observations, Schirmer's I and II tests, ophthalmic examinations, intraocular pressure (IOP) measurements, and histopathology. Study 1 assessments were performed on days -3, 7, 14, 21, 28, 42 (±2 days), and 56 (±2 days). In study 2, a 3-mm diameter corneal defect was created in both eyes of each animal 14 days after the cooling device application. Corneal fluorescein staining was monitored at 3, 6, 24, 30, 48, 54, and 72 hours after defect creation.</p><p><strong>Results: </strong>Minimal changes in conjunctival redness, peripheral corneal haze, and fluorescein staining were observed, which completely self-resolved within 4 weeks after treatment. Schirmer's I and II and IOP results were within normal ranges in all animals. All epithelial defects in both groups had fully healed within 48 hours.</p><p><strong>Conclusions: </strong>No adverse effects were observed within 8 weeks following a single scleral application of the topical cooling device in rabbit eyes.</p><p><strong>Translational relevance: </strong>This article introduces a novel ocular cooling device for the treatment of chronic ocular surface pain, a condition with a considerable unmet need for more effective therapies.</p>","PeriodicalId":23322,"journal":{"name":"Translational Vision Science & Technology","volume":"14 10","pages":"2"},"PeriodicalIF":2.6000,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12510379/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Translational Vision Science & Technology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1167/tvst.14.10.2","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Purpose: To evaluate the preclinical safety of a single treatment of a topical scleral cooling device.
Methods: Two Good Laboratory Practice prospective preclinical device safety studies were performed: study 1 in normal healthy rabbit eyes (n = 5) and study 2 in healthy rabbit eyes that underwent a surgically induced corneal epithelial defect (n = 3). Following sedation, eyes were treated for 10 minutes by applying the cooling device to the sclera. Key assessments for both studies included clinical observations, Schirmer's I and II tests, ophthalmic examinations, intraocular pressure (IOP) measurements, and histopathology. Study 1 assessments were performed on days -3, 7, 14, 21, 28, 42 (±2 days), and 56 (±2 days). In study 2, a 3-mm diameter corneal defect was created in both eyes of each animal 14 days after the cooling device application. Corneal fluorescein staining was monitored at 3, 6, 24, 30, 48, 54, and 72 hours after defect creation.
Results: Minimal changes in conjunctival redness, peripheral corneal haze, and fluorescein staining were observed, which completely self-resolved within 4 weeks after treatment. Schirmer's I and II and IOP results were within normal ranges in all animals. All epithelial defects in both groups had fully healed within 48 hours.
Conclusions: No adverse effects were observed within 8 weeks following a single scleral application of the topical cooling device in rabbit eyes.
Translational relevance: This article introduces a novel ocular cooling device for the treatment of chronic ocular surface pain, a condition with a considerable unmet need for more effective therapies.
期刊介绍：
Translational Vision Science & Technology (TVST), an official journal of the Association for Research in Vision and Ophthalmology (ARVO), an international organization whose purpose is to advance research worldwide into understanding the visual system and preventing, treating and curing its disorders, is an online, open access, peer-reviewed journal emphasizing multidisciplinary research that bridges the gap between basic research and clinical care. A highly qualified and diverse group of Associate Editors and Editorial Board Members is led by Editor-in-Chief Marco Zarbin, MD, PhD, FARVO.
The journal covers a broad spectrum of work, including but not limited to:
Applications of stem cell technology for regenerative medicine,
Development of new animal models of human diseases,
Tissue bioengineering,
Chemical engineering to improve virus-based gene delivery,
Nanotechnology for drug delivery,
Design and synthesis of artificial extracellular matrices,
Development of a true microsurgical operating environment,
Refining data analysis algorithms to improve in vivo imaging technology,
Results of Phase 1 clinical trials,
Reverse translational ("bedside to bench") research.
TVST seeks manuscripts from scientists and clinicians with diverse backgrounds ranging from basic chemistry to ophthalmic surgery that will advance or change the way we understand and/or treat vision-threatening diseases. TVST encourages the use of color, multimedia, hyperlinks, program code and other digital enhancements.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
