Iqbal Ike K Ahmed, John P Berdahl, Arkadiy Yadgarov, George R Reiss, Steven R Sarkisian, Sébastien Gagné, Marco Robles, Lilit A Voskanyan, Omar Sadruddin, Dari Parizadeh, Jane Ellen Giamporcaro, Angela C Kothe, L Jay Katz, Tomas Navratil
{"title":"Six-Month Outcomes from a Prospective, Randomized Study of iStent infinite Versus Hydrus in Open-Angle Glaucoma: The INTEGRITY Study.","authors":"Iqbal Ike K Ahmed, John P Berdahl, Arkadiy Yadgarov, George R Reiss, Steven R Sarkisian, Sébastien Gagné, Marco Robles, Lilit A Voskanyan, Omar Sadruddin, Dari Parizadeh, Jane Ellen Giamporcaro, Angela C Kothe, L Jay Katz, Tomas Navratil","doi":"10.1007/s40123-025-01126-x","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>This was a prospective, randomized, double-masked, multicenter, 24-month study to compare effectiveness and safety outcomes following standalone implantation of two types of current generation trabecular stents in adults with open-angle glaucoma (OAG). An interim analysis was performed at month 6.</p><p><strong>Methods: </strong>Eyes with OAG, mean IOP ≤ 24 mmHg on zero to three intraocular pressure (IOP)-lowering medications at screening, and with baseline mean diurnal IOP (MDIOP) 21-36 mmHg after medication washout were randomized to standalone implantation of the current generation of three trabecular micro-bypass stents (iStent infinite) or one trabecular bypass stent (Hydrus). Eyes on medication were to undergo a medication washout prior to the month 6 visit. Analyses included a comparison of the proportion of iStent infinite versus Hydrus eyes achieving MDIOP reduction of 20% or greater from baseline at month 6. Reduction from baseline in MDIOP and number of medications were also assessed. Safety parameters included intraoperative/postoperative complications, corrected visual acuity, slit-lamp biomicroscopy, ophthalmoscopy, gonioscopy, perimetry, and adverse events.</p><p><strong>Results: </strong>Eyes with primarily mild-to-moderate disease severity were randomized: 91 iStent infinite eyes had screening mean (± standard deviation [SD]) IOP of 17.0 ± 3.2 mmHg on 1.6 ± 0.9 medications and baseline unmedicated MDIOP of 23.7 ± 2.9 mmHg; 89 Hydrus eyes had screening mean (± SD) IOP of 17.1 ± 3.3 mmHg on 1.5 ± 0.9 medications and baseline unmedicated MDIOP of 23.5 ± 2.7 mmHg. At month 6, a similar proportion of iStent infinite eyes (82.7%) versus Hydrus eyes (78.9%) achieved MDIOP reduction ≥ 20% from baseline regardless of IOP medication use or surgical complications. The difference was statistically significantly different (78.2% iStent infinite versus 65.0% Hydrus) for unmedicated MDIOP reduction ≥ 20% from baseline in eyes with no surgical complications (difference 13.2%; 95% confidence interval (CI) 3.0%, 23.3%). Mean MDIOP change from baseline, regardless of IOP medication use or surgical complications, was similar between groups (- 7.4 ± 2.9 mmHg iStent infinite and - 7.2 ± 2.9 mmHg Hydrus), whereas unmedicated MDIOP change from baseline without surgical complications was statistically significantly superior in iStent infinite eyes (- 6.8 ± 4.1 mmHg) versus Hydrus eyes (- 5.7 ± 4.1 mmHg) (difference - 1.1 mmHg; 95% CI - 2.0 mmHg, - 0.2 mmHg). Improper stent placement was reported in one iStent infinite and seven Hydrus eyes (1.1% versus 7.9%). One iStent infinite versus four Hydrus eyes experienced peripheral anterior synechiae > 1 mm (1.1% versus 4.5%). Overall, there were significantly fewer surgical complications in the iStent infinite eyes (3.3%) compared to Hydrus eyes (16.9%; difference of - 13.6%, 95% CI - 23.8%, - 3.4%).</p><p><strong>Conclusions: </strong>In this study of standalone implantation of current trabecular stent technologies in subjects with OAG, high proportions in both groups achieved clinically meaningful IOP reduction. When considering surgical complications as failures, a statistically significantly greater proportion of iStent infinite eyes versus Hydrus eyes had no surgical complications and achieved an unmedicated MDIOP reduction of ≥ 20%. The iStent infinite group also had clinically relevant and statistically significantly superior reduction from baseline in unmedicated MDIOP without surgical complications compared to Hydrus.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT05127551.</p>","PeriodicalId":19623,"journal":{"name":"Ophthalmology and Therapy","volume":" ","pages":""},"PeriodicalIF":2.6000,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Ophthalmology and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40123-025-01126-x","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
Introduction: This was a prospective, randomized, double-masked, multicenter, 24-month study to compare effectiveness and safety outcomes following standalone implantation of two types of current generation trabecular stents in adults with open-angle glaucoma (OAG). An interim analysis was performed at month 6.
Methods: Eyes with OAG, mean IOP ≤ 24 mmHg on zero to three intraocular pressure (IOP)-lowering medications at screening, and with baseline mean diurnal IOP (MDIOP) 21-36 mmHg after medication washout were randomized to standalone implantation of the current generation of three trabecular micro-bypass stents (iStent infinite) or one trabecular bypass stent (Hydrus). Eyes on medication were to undergo a medication washout prior to the month 6 visit. Analyses included a comparison of the proportion of iStent infinite versus Hydrus eyes achieving MDIOP reduction of 20% or greater from baseline at month 6. Reduction from baseline in MDIOP and number of medications were also assessed. Safety parameters included intraoperative/postoperative complications, corrected visual acuity, slit-lamp biomicroscopy, ophthalmoscopy, gonioscopy, perimetry, and adverse events.
Results: Eyes with primarily mild-to-moderate disease severity were randomized: 91 iStent infinite eyes had screening mean (± standard deviation [SD]) IOP of 17.0 ± 3.2 mmHg on 1.6 ± 0.9 medications and baseline unmedicated MDIOP of 23.7 ± 2.9 mmHg; 89 Hydrus eyes had screening mean (± SD) IOP of 17.1 ± 3.3 mmHg on 1.5 ± 0.9 medications and baseline unmedicated MDIOP of 23.5 ± 2.7 mmHg. At month 6, a similar proportion of iStent infinite eyes (82.7%) versus Hydrus eyes (78.9%) achieved MDIOP reduction ≥ 20% from baseline regardless of IOP medication use or surgical complications. The difference was statistically significantly different (78.2% iStent infinite versus 65.0% Hydrus) for unmedicated MDIOP reduction ≥ 20% from baseline in eyes with no surgical complications (difference 13.2%; 95% confidence interval (CI) 3.0%, 23.3%). Mean MDIOP change from baseline, regardless of IOP medication use or surgical complications, was similar between groups (- 7.4 ± 2.9 mmHg iStent infinite and - 7.2 ± 2.9 mmHg Hydrus), whereas unmedicated MDIOP change from baseline without surgical complications was statistically significantly superior in iStent infinite eyes (- 6.8 ± 4.1 mmHg) versus Hydrus eyes (- 5.7 ± 4.1 mmHg) (difference - 1.1 mmHg; 95% CI - 2.0 mmHg, - 0.2 mmHg). Improper stent placement was reported in one iStent infinite and seven Hydrus eyes (1.1% versus 7.9%). One iStent infinite versus four Hydrus eyes experienced peripheral anterior synechiae > 1 mm (1.1% versus 4.5%). Overall, there were significantly fewer surgical complications in the iStent infinite eyes (3.3%) compared to Hydrus eyes (16.9%; difference of - 13.6%, 95% CI - 23.8%, - 3.4%).
Conclusions: In this study of standalone implantation of current trabecular stent technologies in subjects with OAG, high proportions in both groups achieved clinically meaningful IOP reduction. When considering surgical complications as failures, a statistically significantly greater proportion of iStent infinite eyes versus Hydrus eyes had no surgical complications and achieved an unmedicated MDIOP reduction of ≥ 20%. The iStent infinite group also had clinically relevant and statistically significantly superior reduction from baseline in unmedicated MDIOP without surgical complications compared to Hydrus.
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.
Preprints
We encourage posting of preprints of primary research manuscripts on preprint servers, authors’ or institutional websites, and open communications between researchers whether on community preprint servers or preprint commenting platforms. Posting of preprints is not considered prior publication and will not jeopardize consideration in our journals. Authors should disclose details of preprint posting during the submission process or at any other point during consideration in one of our journals. Once the manuscript is published, it is the author’s responsibility to ensure that the preprint record is updated with a publication reference, including the DOI and a URL link to the published version of the article on the journal website.
Please follow the link for further information on preprint sharing:
https://www.springer.com/gp/authors-editors/journal-author/journal-author-helpdesk/submission/1302#c16721550
Copyright
Ophthalmology and Therapy''s content is published open access under the Creative Commons Attribution-Noncommercial License, which allows users to read, copy, distribute, and make derivative works for non-commercial purposes from the material, as long as the author of the original work is cited. The author assigns the exclusive right to any commercial use of the article to Springer. For more information about the Creative Commons Attribution-Noncommercial License, click here: http://creativecommons.org/licenses/by-nc/4.0.
Contact
For more information about the journal, including pre-submission enquiries, please contact christopher.vautrinot@springer.com.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
