.: ORİJİNAL ARAŞTIRMA
Early Experience Results with Minimally Invasive Glaucoma Surgery with XEN® Gel Stent
XEN® Jel Stent ile Minimal İnvaziv Glokom Cerrahisi Erken Deneyim Sonuçları
Turkiye Klinikleri J Ophthalmol. 2020;29(4):300-7
doi: 10.5336/ophthal.2020-74983
Makale Dili: EN
Tam Metin
ABSTRACT
Objective: To evaluate the results of XEN® gel stent implantation. Material and Methods: Thirty-five eyes of 33 patients who underwent XEN gel stent implantation were retrospectively evaluated. The primary outcome measure was target intraocular pressure (IOP). Complete therapeutic success was defined as postoperative IOP≤21 mmHg without antiglaucomatous medication; partial success was defined as postoperative IOP≤21 mmHg with antiglaucomatous medication. The secondary outcome measure was ≥20% reduction in IOP from baseline. Failure was defined as postoperative IOP>21 mmHg, explantation and the need for additional glaucoma surgery. Results: The mean preoperative IOP was 25.7±5.8 mmHg and the mean antiglaucomatous medication was 2.7±1.5. After 12 months follow-up, mean IOP was 16.5±4.2 mmHg with a decrease of 33.7%, mean antiglaucomatous medication was 1.8±1.6 with a decrease of 43.9% (p<0.05). When the cases who completed the 12-month follow-up were evaluated, the complete success rate was 23.1% (n=6), the partial success rate was 42.3% (n=11) and the failure rate was 34.6% (n=9) at month 12. In 61.5% of eyes achieved an IOP decrease of 20% or more. Needling was required for 51.4% of eyes. Most of the complications were resolved without any permanent damage in the early period. Serious complications included malignant glaucoma in one eye and endophthalmitis in one eye. XEN gel stent explantation was performed in 22.8% (n=8) of the cases. Conclusion: Although XEN gel stent implantation is a minimally invasive method, some postoperative interventions were required. Success rates may increase with the effective management of complications. It may provide a significant decrease in IOP in selected patients.
Keywords: Glaucoma; glaucoma drainage implants; minimally invasive surgical procedures; XEN® gel stent
Objective: To evaluate the results of XEN® gel stent implantation. Material and Methods: Thirty-five eyes of 33 patients who underwent XEN gel stent implantation were retrospectively evaluated. The primary outcome measure was target intraocular pressure (IOP). Complete therapeutic success was defined as postoperative IOP≤21 mmHg without antiglaucomatous medication; partial success was defined as postoperative IOP≤21 mmHg with antiglaucomatous medication. The secondary outcome measure was ≥20% reduction in IOP from baseline. Failure was defined as postoperative IOP>21 mmHg, explantation and the need for additional glaucoma surgery. Results: The mean preoperative IOP was 25.7±5.8 mmHg and the mean antiglaucomatous medication was 2.7±1.5. After 12 months follow-up, mean IOP was 16.5±4.2 mmHg with a decrease of 33.7%, mean antiglaucomatous medication was 1.8±1.6 with a decrease of 43.9% (p<0.05). When the cases who completed the 12-month follow-up were evaluated, the complete success rate was 23.1% (n=6), the partial success rate was 42.3% (n=11) and the failure rate was 34.6% (n=9) at month 12. In 61.5% of eyes achieved an IOP decrease of 20% or more. Needling was required for 51.4% of eyes. Most of the complications were resolved without any permanent damage in the early period. Serious complications included malignant glaucoma in one eye and endophthalmitis in one eye. XEN gel stent explantation was performed in 22.8% (n=8) of the cases. Conclusion: Although XEN gel stent implantation is a minimally invasive method, some postoperative interventions were required. Success rates may increase with the effective management of complications. It may provide a significant decrease in IOP in selected patients.
Keywords: Glaucoma; glaucoma drainage implants; minimally invasive surgical procedures; XEN® gel stent
ÖZET
Amaç: XEN® jel stent implantasyonu sonuçlarını değerlendirmektir. Gereç ve Yöntemler: XEN jel stent implantasyonu yapılan 33 hastanın 35 gözü retrospektif olarak incelendi. Birincil sonuç ölçütü hedef göz içi basıncı (GİB) idi. Tam terapötik başarı, antiglokomatöz ilaçsız postoperatif GİB≤21 mmHg; kısmi başarı ise antiglokomatöz ilaçla postoprtatif GİB≤21 mmHg olarak tanımlandı. İkincil sonuç ölçütü, başlangıçtaki GİB değerinden %20 ve daha fazla azalma olarak değerlendirildi. Başarısızlık GİB>21 mmHg, eksplantasyon ve ek glokom cerrahisine ihtiyaç olarak tanımlandı. Bulgular: Ameliyat öncesi ortalama GİB 25,7±5,8 mmHg ve ortalama antiglokomatöz ilaç sayısı 2,7±1,5 idi. On iki aylık takipten sonra ortalama GİB %33,7 azalmayla 16,5±4,2 mmHg, ortalama antiglokomatöz ilaç sayısı %43,9 azalmayla 1,8±1,6 (p (p<0,05) idi. Bir yıllık takibini tamamlayan hastalar değerlendirildiğinde, tam başarı oranı %23,1 (n=6), kısmi başarı oranı %42,3 (n=11) ve başarısızlık oranı %34,6 (n=9) idi. Gözlerin %61,5'inde %20 veya daha fazla GİB azalması elde edildi. Gözlerin %51,4'ünde bleb iğnelemeye ihtiyaç duyuldu. Komplikasyonların çoğu erken dönemde kalıcı bir hasar bırakmadan düzeldi. Ciddi komplikasyonlardan bir gözde malign glokom ve bir gözde endoftalmi vardı. Olguların %22,8 (n=8)'inde XEN jel stent explantasyonu yapıldı. Sonuç: XEN jel stent implantasyonu minimal invaziv bir yöntem olmasına rağmen, bazı postoperatif müdahaleler gerekli olmuştur. Komplikasyonların etkin yönetimi ile başarı oranları artabilir. Seçilmiş hastalarda GİB'de anlamlı bir düşüş sağlayabilir.
Anahtar Kelimeler: Glokom; glokom drenaj implantları; minimal invaziv cerrahi işlemler; XEN® jel stent
Amaç: XEN® jel stent implantasyonu sonuçlarını değerlendirmektir. Gereç ve Yöntemler: XEN jel stent implantasyonu yapılan 33 hastanın 35 gözü retrospektif olarak incelendi. Birincil sonuç ölçütü hedef göz içi basıncı (GİB) idi. Tam terapötik başarı, antiglokomatöz ilaçsız postoperatif GİB≤21 mmHg; kısmi başarı ise antiglokomatöz ilaçla postoprtatif GİB≤21 mmHg olarak tanımlandı. İkincil sonuç ölçütü, başlangıçtaki GİB değerinden %20 ve daha fazla azalma olarak değerlendirildi. Başarısızlık GİB>21 mmHg, eksplantasyon ve ek glokom cerrahisine ihtiyaç olarak tanımlandı. Bulgular: Ameliyat öncesi ortalama GİB 25,7±5,8 mmHg ve ortalama antiglokomatöz ilaç sayısı 2,7±1,5 idi. On iki aylık takipten sonra ortalama GİB %33,7 azalmayla 16,5±4,2 mmHg, ortalama antiglokomatöz ilaç sayısı %43,9 azalmayla 1,8±1,6 (p (p<0,05) idi. Bir yıllık takibini tamamlayan hastalar değerlendirildiğinde, tam başarı oranı %23,1 (n=6), kısmi başarı oranı %42,3 (n=11) ve başarısızlık oranı %34,6 (n=9) idi. Gözlerin %61,5'inde %20 veya daha fazla GİB azalması elde edildi. Gözlerin %51,4'ünde bleb iğnelemeye ihtiyaç duyuldu. Komplikasyonların çoğu erken dönemde kalıcı bir hasar bırakmadan düzeldi. Ciddi komplikasyonlardan bir gözde malign glokom ve bir gözde endoftalmi vardı. Olguların %22,8 (n=8)'inde XEN jel stent explantasyonu yapıldı. Sonuç: XEN jel stent implantasyonu minimal invaziv bir yöntem olmasına rağmen, bazı postoperatif müdahaleler gerekli olmuştur. Komplikasyonların etkin yönetimi ile başarı oranları artabilir. Seçilmiş hastalarda GİB'de anlamlı bir düşüş sağlayabilir.
Anahtar Kelimeler: Glokom; glokom drenaj implantları; minimal invaziv cerrahi işlemler; XEN® jel stent
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