.: ORİJİNAL ARAŞTIRMA
Surgery of Xen45 Gel Micro-Implant and Phacoemulsification: Cross-Sectional Research
Xen45 Jel Mikroimplant ve Fakoemülsikasyon Cerrahisi: Kesitsel Araştırma
Turkiye Klinikleri J Ophthalmol. 2025;34(3):85-90
doi: 10.5336/ophthal.2024-104314
Makale Dili: EN
Tam Metin
ABSTRACT
Objective: To investigate the safety and effectiveness of XEN45 gel micro-implant and phacoemulsification combined surgery in primary open-angle glaucoma (POAG) patients. Material and Methods: It is a prospective, single-center, clinical study. 30 patients (30 eyes) who were followed up by Marmara University Glaucoma outpatient clinic due to POAG and cataract were included in the study. Moreover, all patients underwent XEN45 gel micro-implant- phacoemulsification combined surgery. Best corrected visual acuity, slit-lamb biomicroscopic examination, intraocular pressure measurement with applanation, Retinal Nerve Fiber Layer and Ganglion Cell Complex scanning were followed up to the 1st post-operative year. Results: Of the participants diagnosed with POAG and cataract, 50% were female, 50% were male, and the average age was 62.63±7.05. A statistically significant decrease was detected in the number of pre-operative antiglaucomatous molecules used by the patients (3.24±0.95) at the end of 1 year (0.66±0.72) (p=0.001). A significant difference was detected between pre and post-operative month 12 intraocular pressure values (22.53±3.81, 14.53±2.86 mmHg, respectively) (p<0.001). At the end of 1 year, the full success rate was 40% and the partial success rate was 36.67%. Conclusion: It was concluded that in addition to being a micro-invasive, effective and reliable surgery, the XEN45 gel micro-implant has been observed to reduce POAG progression and the use of anti-glaucomatous drops.
Keywords: Open angle glaucoma; minimally invasive surgical procedures; phacoemulsification; surgery; safety
Objective: To investigate the safety and effectiveness of XEN45 gel micro-implant and phacoemulsification combined surgery in primary open-angle glaucoma (POAG) patients. Material and Methods: It is a prospective, single-center, clinical study. 30 patients (30 eyes) who were followed up by Marmara University Glaucoma outpatient clinic due to POAG and cataract were included in the study. Moreover, all patients underwent XEN45 gel micro-implant- phacoemulsification combined surgery. Best corrected visual acuity, slit-lamb biomicroscopic examination, intraocular pressure measurement with applanation, Retinal Nerve Fiber Layer and Ganglion Cell Complex scanning were followed up to the 1st post-operative year. Results: Of the participants diagnosed with POAG and cataract, 50% were female, 50% were male, and the average age was 62.63±7.05. A statistically significant decrease was detected in the number of pre-operative antiglaucomatous molecules used by the patients (3.24±0.95) at the end of 1 year (0.66±0.72) (p=0.001). A significant difference was detected between pre and post-operative month 12 intraocular pressure values (22.53±3.81, 14.53±2.86 mmHg, respectively) (p<0.001). At the end of 1 year, the full success rate was 40% and the partial success rate was 36.67%. Conclusion: It was concluded that in addition to being a micro-invasive, effective and reliable surgery, the XEN45 gel micro-implant has been observed to reduce POAG progression and the use of anti-glaucomatous drops.
Keywords: Open angle glaucoma; minimally invasive surgical procedures; phacoemulsification; surgery; safety
ÖZET
Amaç: Primer açık açılı glokom [Primary open-angle glaucoma (POAG)] hastalarında XEN45 jel mikro-implant ve fakoemülsifikasyon kombine cerrahisinin güvenilirlik ve etkililiğinin araştırılması. Gereç ve Yöntemler: Prospektif, tek merkezli, klinik çalışmaya Marmara Üniversitesi Glokom polikliniği tarafından POAG ve katarakt nedeniyle takip edilen 30 hasta (30 göz) dâhil edildi. Dahası tüm hastalara XEN45 jel mikroimplant-fakoemülsifikasyon kombine cerrahi uygulandı. En iyi düzeltilmiş görme keskinliği, slit-lamb biyomikroskopik muayene, aplanasyon ile göz içi basıncı ölçümü, Retinal Sinir Lifi Tabakası ve Gangliyon Hücre Kompleksi taraması ile postoperatif 1 sene boyunca takip edildi. Bulgular: POAG ve katarakt tanılı katılımcıların %50'si kadın, %50'si erkek ve yaş ortalaması 62,63±7,05'tir. Hastaların kullandıkları preoperatif antiglokomatöz molekül sayısında (3,24±0,95), 1 yılın sonunda (0,66±0,72) istatistiksel olarak anlamlı düşüş saptandı (p=0,001). Pre ve post-operatif 12. ay göz içi basıncı değerleri (sırasıyla 22,53±3,81, 14,53±2,86 mmHg) arasında anlamlı fark saptandı (p<0,001). Bir senenin sonunda cerrahi tam başarı oranı %40, kısmi başarı oranı ise %36,67'dir. Sonuç: XEN45 jel mikro-implantın mikroinvaziv, etkili ve güvenilir bir cerrahi yöntem olmasının yanı sıra POAG progresyonunu ve antiglokomatöz damla kullanımını azalttığı sonucuna varılmıştır.
Anahtar Kelimeler: Açık açılı glokom; minimal invaziv cerrahi prosedürler; fakoemülsifikasyon; ameliyat; güvenilirlik
Amaç: Primer açık açılı glokom [Primary open-angle glaucoma (POAG)] hastalarında XEN45 jel mikro-implant ve fakoemülsifikasyon kombine cerrahisinin güvenilirlik ve etkililiğinin araştırılması. Gereç ve Yöntemler: Prospektif, tek merkezli, klinik çalışmaya Marmara Üniversitesi Glokom polikliniği tarafından POAG ve katarakt nedeniyle takip edilen 30 hasta (30 göz) dâhil edildi. Dahası tüm hastalara XEN45 jel mikroimplant-fakoemülsifikasyon kombine cerrahi uygulandı. En iyi düzeltilmiş görme keskinliği, slit-lamb biyomikroskopik muayene, aplanasyon ile göz içi basıncı ölçümü, Retinal Sinir Lifi Tabakası ve Gangliyon Hücre Kompleksi taraması ile postoperatif 1 sene boyunca takip edildi. Bulgular: POAG ve katarakt tanılı katılımcıların %50'si kadın, %50'si erkek ve yaş ortalaması 62,63±7,05'tir. Hastaların kullandıkları preoperatif antiglokomatöz molekül sayısında (3,24±0,95), 1 yılın sonunda (0,66±0,72) istatistiksel olarak anlamlı düşüş saptandı (p=0,001). Pre ve post-operatif 12. ay göz içi basıncı değerleri (sırasıyla 22,53±3,81, 14,53±2,86 mmHg) arasında anlamlı fark saptandı (p<0,001). Bir senenin sonunda cerrahi tam başarı oranı %40, kısmi başarı oranı ise %36,67'dir. Sonuç: XEN45 jel mikro-implantın mikroinvaziv, etkili ve güvenilir bir cerrahi yöntem olmasının yanı sıra POAG progresyonunu ve antiglokomatöz damla kullanımını azalttığı sonucuna varılmıştır.
Anahtar Kelimeler: Açık açılı glokom; minimal invaziv cerrahi prosedürler; fakoemülsifikasyon; ameliyat; güvenilirlik
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