Wesam Shamseldin Shalaby MD , Rohit Reddy BS , Brandon Wummer MD , Ping Huang MD , Daniel Lee MD , Reza Razeghinejad MD , Michael J. Pro MD
{"title":"Ahmed ClearPath 与 Baerveldt 青光眼植入物:回顾性非劣效性比较研究","authors":"Wesam Shamseldin Shalaby MD , Rohit Reddy BS , Brandon Wummer MD , Ping Huang MD , Daniel Lee MD , Reza Razeghinejad MD , Michael J. Pro MD","doi":"10.1016/j.ogla.2023.12.006","DOIUrl":null,"url":null,"abstract":"<div><h3>Purpose</h3><p>To compare the efficacy and safety of 2 nonvalved glaucoma drainage devices (GDDs): Ahmed ClearPath (ACP) vs. Baerveldt glaucoma implant (BGI).</p></div><div><h3>Design</h3><p>Single-center, retrospective, comparative study.</p></div><div><h3>Participants</h3><p>Consecutive patients who underwent ACP or BGI surgery for glaucoma (250 mm<sup>2</sup> or 350 mm<sup>2</sup> models), had ≥ 6 months of follow-up, and no prior GDD implantation.</p></div><div><h3>Methods</h3><p>Chart review of ACP or BGI surgery in patients with glaucoma at Wills Eye Hospital (2020–2023).</p></div><div><h3>Main Outcome Measures</h3><p>The primary outcome measure was surgical failure at the end of follow-up, defined as intraocular pressure (IOP) > 21 or < 6 mmHg at 2 consecutive visits, progression to no light perception (NLP) vision, glaucoma reoperation, or implant removal. Secondary outcome measures included the rate of postoperative complications and changes in best corrected visual acuity (BCVA), IOP, and glaucoma medications.</p></div><div><h3>Results</h3><p>A total of 128 eyes of 113 patients (63 ACP, 65 BGI) with similar baseline characteristics and a mean follow-up duration of 19.6 ± 10.8 (median 20.5) months were included. Surgical failure occurred in 12 eyes (9.4%) with no significant difference between ACP and BGI eyes (9.5% vs. 9.2%, respectively; <em>P</em> = 0.810). Reasons for failure included IOP > 21 mmHg (3/12, 25.0%), glaucoma reoperation (5/12, 41.7%), and tube removal (4/12, 33.3%). No eyes progressed to NLP vision. Kaplan–Meier survival analysis showed similar cumulative rate of surgical failure in both groups (<em>P</em> = 0.871). Both groups achieved significant IOP and medication reduction compared to their baseline. Final IOP, BCVA, and complication rates were similar in both groups, but medication number was significantly lower in the ACP group (<em>P</em> = 0.012). Both the 250 mm<sup>2</sup> and 350 mm<sup>2</sup> models had similar outcomes, but diplopia was significantly associated with the 350 mm<sup>2</sup> model of either implant (<em>P</em> = 0.012). Univariate logistic regression analysis did not identify either tube type or plate size as predictors of surgical failure.</p></div><div><h3>Conclusions</h3><p>This study compares the recently approved ACP vs. BGI. Both implants had similar surgical failures and complication rates. Final IOP was similar in both groups, but ACP achieved lower medication number. Diplopia was significantly associated with the use of 350 mm<sup>2</sup> model of either implant. Neither tube type nor plate size were significant predictors of surgical failure.</p></div><div><h3>Financial Disclosure(s)</h3><p>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</p></div>","PeriodicalId":19519,"journal":{"name":"Ophthalmology. Glaucoma","volume":"7 3","pages":"Pages 251-259"},"PeriodicalIF":2.8000,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Ahmed ClearPath vs. Baerveldt Glaucoma Implant\",\"authors\":\"Wesam Shamseldin Shalaby MD , Rohit Reddy BS , Brandon Wummer MD , Ping Huang MD , Daniel Lee MD , Reza Razeghinejad MD , Michael J. Pro MD\",\"doi\":\"10.1016/j.ogla.2023.12.006\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Purpose</h3><p>To compare the efficacy and safety of 2 nonvalved glaucoma drainage devices (GDDs): Ahmed ClearPath (ACP) vs. Baerveldt glaucoma implant (BGI).</p></div><div><h3>Design</h3><p>Single-center, retrospective, comparative study.</p></div><div><h3>Participants</h3><p>Consecutive patients who underwent ACP or BGI surgery for glaucoma (250 mm<sup>2</sup> or 350 mm<sup>2</sup> models), had ≥ 6 months of follow-up, and no prior GDD implantation.</p></div><div><h3>Methods</h3><p>Chart review of ACP or BGI surgery in patients with glaucoma at Wills Eye Hospital (2020–2023).</p></div><div><h3>Main Outcome Measures</h3><p>The primary outcome measure was surgical failure at the end of follow-up, defined as intraocular pressure (IOP) > 21 or < 6 mmHg at 2 consecutive visits, progression to no light perception (NLP) vision, glaucoma reoperation, or implant removal. Secondary outcome measures included the rate of postoperative complications and changes in best corrected visual acuity (BCVA), IOP, and glaucoma medications.</p></div><div><h3>Results</h3><p>A total of 128 eyes of 113 patients (63 ACP, 65 BGI) with similar baseline characteristics and a mean follow-up duration of 19.6 ± 10.8 (median 20.5) months were included. Surgical failure occurred in 12 eyes (9.4%) with no significant difference between ACP and BGI eyes (9.5% vs. 9.2%, respectively; <em>P</em> = 0.810). Reasons for failure included IOP > 21 mmHg (3/12, 25.0%), glaucoma reoperation (5/12, 41.7%), and tube removal (4/12, 33.3%). No eyes progressed to NLP vision. Kaplan–Meier survival analysis showed similar cumulative rate of surgical failure in both groups (<em>P</em> = 0.871). Both groups achieved significant IOP and medication reduction compared to their baseline. Final IOP, BCVA, and complication rates were similar in both groups, but medication number was significantly lower in the ACP group (<em>P</em> = 0.012). Both the 250 mm<sup>2</sup> and 350 mm<sup>2</sup> models had similar outcomes, but diplopia was significantly associated with the 350 mm<sup>2</sup> model of either implant (<em>P</em> = 0.012). Univariate logistic regression analysis did not identify either tube type or plate size as predictors of surgical failure.</p></div><div><h3>Conclusions</h3><p>This study compares the recently approved ACP vs. BGI. Both implants had similar surgical failures and complication rates. Final IOP was similar in both groups, but ACP achieved lower medication number. Diplopia was significantly associated with the use of 350 mm<sup>2</sup> model of either implant. Neither tube type nor plate size were significant predictors of surgical failure.</p></div><div><h3>Financial Disclosure(s)</h3><p>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</p></div>\",\"PeriodicalId\":19519,\"journal\":{\"name\":\"Ophthalmology. Glaucoma\",\"volume\":\"7 3\",\"pages\":\"Pages 251-259\"},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2024-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Ophthalmology. Glaucoma\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2589419623002314\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"OPHTHALMOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Ophthalmology. Glaucoma","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2589419623002314","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
To compare the efficacy and safety of 2 nonvalved glaucoma drainage devices (GDDs): Ahmed ClearPath (ACP) vs. Baerveldt glaucoma implant (BGI).
Design
Single-center, retrospective, comparative study.
Participants
Consecutive patients who underwent ACP or BGI surgery for glaucoma (250 mm2 or 350 mm2 models), had ≥ 6 months of follow-up, and no prior GDD implantation.
Methods
Chart review of ACP or BGI surgery in patients with glaucoma at Wills Eye Hospital (2020–2023).
Main Outcome Measures
The primary outcome measure was surgical failure at the end of follow-up, defined as intraocular pressure (IOP) > 21 or < 6 mmHg at 2 consecutive visits, progression to no light perception (NLP) vision, glaucoma reoperation, or implant removal. Secondary outcome measures included the rate of postoperative complications and changes in best corrected visual acuity (BCVA), IOP, and glaucoma medications.
Results
A total of 128 eyes of 113 patients (63 ACP, 65 BGI) with similar baseline characteristics and a mean follow-up duration of 19.6 ± 10.8 (median 20.5) months were included. Surgical failure occurred in 12 eyes (9.4%) with no significant difference between ACP and BGI eyes (9.5% vs. 9.2%, respectively; P = 0.810). Reasons for failure included IOP > 21 mmHg (3/12, 25.0%), glaucoma reoperation (5/12, 41.7%), and tube removal (4/12, 33.3%). No eyes progressed to NLP vision. Kaplan–Meier survival analysis showed similar cumulative rate of surgical failure in both groups (P = 0.871). Both groups achieved significant IOP and medication reduction compared to their baseline. Final IOP, BCVA, and complication rates were similar in both groups, but medication number was significantly lower in the ACP group (P = 0.012). Both the 250 mm2 and 350 mm2 models had similar outcomes, but diplopia was significantly associated with the 350 mm2 model of either implant (P = 0.012). Univariate logistic regression analysis did not identify either tube type or plate size as predictors of surgical failure.
Conclusions
This study compares the recently approved ACP vs. BGI. Both implants had similar surgical failures and complication rates. Final IOP was similar in both groups, but ACP achieved lower medication number. Diplopia was significantly associated with the use of 350 mm2 model of either implant. Neither tube type nor plate size were significant predictors of surgical failure.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.