Aline Domingos Pinto Ruppert, Nara Gravina Ogata, Leopoldo Ernesto Oiticica Barbosa, Paulo Silas Neroni Stina, Marcus Vinícius Takatsu, Ernst Werner Oltrogge, Marcelo Hatanaka
{"title":"苏珊娜UF假体治疗难治性先天性青光眼的疗效","authors":"Aline Domingos Pinto Ruppert, Nara Gravina Ogata, Leopoldo Ernesto Oiticica Barbosa, Paulo Silas Neroni Stina, Marcus Vinícius Takatsu, Ernst Werner Oltrogge, Marcelo Hatanaka","doi":"10.1016/j.clinsp.2025.100619","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><div>This study aimed to evaluate the success and complication rates of the Susanna UF Glaucoma Drainage Device (SUFGDD) in treating refractory primary congenital glaucoma.</div></div><div><h3>Patients and methods</h3><div>In this prospective non-comparative clinical trial, patients with refractory primary congenital glaucoma, under 18-years-old, who had unsuccessful prior glaucoma surgeries, underwent standardized SUFGDD implant surgery. All procedures were performed by a single surgeon (A.D.P.R.). Pre and postoperative intraocular pressure (IOP), number of antiglaucoma eye drops, surgical complications, and any subsequent related events were recorded. Success criteria were defined as follows: (I) IOP ≥ 5 and ≤ 21 mmHg; (II) IOP ≥ 5 and ≤ 18 mmHg. Each group was further categorized as absolute success (without medication) or qualified success (including those with medication).</div></div><div><h3>Results</h3><div>The study included 45 eyes from 31 patients, with an average age of 6.14 ± 5.02 years (range: 9 months‒18 years). The mean follow-up time was 37.78 ± 10.44 months. Mean IOP decreased from 28.18 ± 5.69 mmHg to 14.73 ± 2.90 mmHg (<em>p</em> < 0.05). The average number of antiglaucoma medications was reduced from 2.96 ± 0.74 to 1.40 ± 1.23 (<em>p</em> < 0.05). At 36-months postoperatively, the qualified success rates for criteria I and II were 93.3 % and 77.8 %, respectively. Seven eyes (15.6 %) experienced complications, all of which required reoperation; six cases were successfully managed, while one case resulted in permanent vision loss due to endophthalmitis. There were no significant associations between complications and analyzed risk factors (e.g., number of previous surgeries, age at surgery, past glaucoma surgeries, preoperative IOP, and number of preoperative eye drops). However, an association was observed between the occurrence of complications and surgical failure in the qualified success group for criterion II (HR = 6.50; 95 % CI 1.20‒31.35; <em>p</em> = 0.029).</div></div><div><h3>Conclusion</h3><div>In this studied cohort, SUFGDD achieved qualified success rates of 93.3 % and 77.8 %, for criteria I and II, respectively, at 36-months, with a complication rate of 15.6 %.</div></div>","PeriodicalId":10472,"journal":{"name":"Clinics","volume":"80 ","pages":"Article 100619"},"PeriodicalIF":2.2000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Outcomes of Susanna UF implants in refractory congenital glaucoma\",\"authors\":\"Aline Domingos Pinto Ruppert, Nara Gravina Ogata, Leopoldo Ernesto Oiticica Barbosa, Paulo Silas Neroni Stina, Marcus Vinícius Takatsu, Ernst Werner Oltrogge, Marcelo Hatanaka\",\"doi\":\"10.1016/j.clinsp.2025.100619\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><div>This study aimed to evaluate the success and complication rates of the Susanna UF Glaucoma Drainage Device (SUFGDD) in treating refractory primary congenital glaucoma.</div></div><div><h3>Patients and methods</h3><div>In this prospective non-comparative clinical trial, patients with refractory primary congenital glaucoma, under 18-years-old, who had unsuccessful prior glaucoma surgeries, underwent standardized SUFGDD implant surgery. All procedures were performed by a single surgeon (A.D.P.R.). Pre and postoperative intraocular pressure (IOP), number of antiglaucoma eye drops, surgical complications, and any subsequent related events were recorded. Success criteria were defined as follows: (I) IOP ≥ 5 and ≤ 21 mmHg; (II) IOP ≥ 5 and ≤ 18 mmHg. Each group was further categorized as absolute success (without medication) or qualified success (including those with medication).</div></div><div><h3>Results</h3><div>The study included 45 eyes from 31 patients, with an average age of 6.14 ± 5.02 years (range: 9 months‒18 years). The mean follow-up time was 37.78 ± 10.44 months. Mean IOP decreased from 28.18 ± 5.69 mmHg to 14.73 ± 2.90 mmHg (<em>p</em> < 0.05). The average number of antiglaucoma medications was reduced from 2.96 ± 0.74 to 1.40 ± 1.23 (<em>p</em> < 0.05). At 36-months postoperatively, the qualified success rates for criteria I and II were 93.3 % and 77.8 %, respectively. Seven eyes (15.6 %) experienced complications, all of which required reoperation; six cases were successfully managed, while one case resulted in permanent vision loss due to endophthalmitis. There were no significant associations between complications and analyzed risk factors (e.g., number of previous surgeries, age at surgery, past glaucoma surgeries, preoperative IOP, and number of preoperative eye drops). However, an association was observed between the occurrence of complications and surgical failure in the qualified success group for criterion II (HR = 6.50; 95 % CI 1.20‒31.35; <em>p</em> = 0.029).</div></div><div><h3>Conclusion</h3><div>In this studied cohort, SUFGDD achieved qualified success rates of 93.3 % and 77.8 %, for criteria I and II, respectively, at 36-months, with a complication rate of 15.6 %.</div></div>\",\"PeriodicalId\":10472,\"journal\":{\"name\":\"Clinics\",\"volume\":\"80 \",\"pages\":\"Article 100619\"},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2025-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinics\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1807593225000456\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinics","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1807593225000456","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Outcomes of Susanna UF implants in refractory congenital glaucoma
Objective
This study aimed to evaluate the success and complication rates of the Susanna UF Glaucoma Drainage Device (SUFGDD) in treating refractory primary congenital glaucoma.
Patients and methods
In this prospective non-comparative clinical trial, patients with refractory primary congenital glaucoma, under 18-years-old, who had unsuccessful prior glaucoma surgeries, underwent standardized SUFGDD implant surgery. All procedures were performed by a single surgeon (A.D.P.R.). Pre and postoperative intraocular pressure (IOP), number of antiglaucoma eye drops, surgical complications, and any subsequent related events were recorded. Success criteria were defined as follows: (I) IOP ≥ 5 and ≤ 21 mmHg; (II) IOP ≥ 5 and ≤ 18 mmHg. Each group was further categorized as absolute success (without medication) or qualified success (including those with medication).
Results
The study included 45 eyes from 31 patients, with an average age of 6.14 ± 5.02 years (range: 9 months‒18 years). The mean follow-up time was 37.78 ± 10.44 months. Mean IOP decreased from 28.18 ± 5.69 mmHg to 14.73 ± 2.90 mmHg (p < 0.05). The average number of antiglaucoma medications was reduced from 2.96 ± 0.74 to 1.40 ± 1.23 (p < 0.05). At 36-months postoperatively, the qualified success rates for criteria I and II were 93.3 % and 77.8 %, respectively. Seven eyes (15.6 %) experienced complications, all of which required reoperation; six cases were successfully managed, while one case resulted in permanent vision loss due to endophthalmitis. There were no significant associations between complications and analyzed risk factors (e.g., number of previous surgeries, age at surgery, past glaucoma surgeries, preoperative IOP, and number of preoperative eye drops). However, an association was observed between the occurrence of complications and surgical failure in the qualified success group for criterion II (HR = 6.50; 95 % CI 1.20‒31.35; p = 0.029).
Conclusion
In this studied cohort, SUFGDD achieved qualified success rates of 93.3 % and 77.8 %, for criteria I and II, respectively, at 36-months, with a complication rate of 15.6 %.
期刊介绍:
CLINICS is an electronic journal that publishes peer-reviewed articles in continuous flow, of interest to clinicians and researchers in the medical sciences. CLINICS complies with the policies of funding agencies which request or require deposition of the published articles that they fund into publicly available databases. CLINICS supports the position of the International Committee of Medical Journal Editors (ICMJE) on trial registration.