BACKGROUND: Trabeculectomy (TE) has been the standard procedure in glaucoma surgery for a long time. This study examined the efficacy and safety profile of XEN45 Gel Stent (XEN) after failed and/or scarred trabeculectomy. MATERIAL AND METHODS: We analysed all files of patients, who received a XEN after insufficient TE and examined changes in intraocular pressure (IOP), IOP-lowering medication, best corrected visual acuity, visual field tests as well as the intra- and postoperative complications recorded within a 12-month follow-up period. RESULTS: 31 eyes of 28 patients were analysed in our study (mean age: 66,2 ± 13,4 years; 39% female; 48% right eye; mean follow-up after TE: 70,3 ± 64,9 months). The mean IOP decreased from 23,5 ± 6,5 to 18,0 ± 5,3 mmHg (- 23,5% compared to baseline-IOP; p = 0,01) while the mean IOP-lowering medication could be reduced from 2,8 ± 1,1 to 1,1 ± 1,5 (p < 0,01) 12 months after XEN-implantation. The mean visual acuity did not change significantly (pre-op: 0,5 ± 0,6 logMAR; 12 months post-op: 0,5 ± 0,6 logMAR). The most common complications postoperatively were choroideal detachment due to postoperative hypotony in 4 eyes (13%), a needling procedure in 9 eyes (29%), a Re-XEN-Implantation in 4 eyes (13%), an open revision of the conjunctiva in 3 eyes (10%), and a Re-TE in 1 eye (3%) as well as an Ahmed-Valve implantation in 2 eyes (6%). Overall, neither needling procedure nor further glaucoma surgery was necessary in 19 eyes (61%). In 10 of 22 evaluable eyes (45%) an IOP reduction of > 20% was achieved 12 months after XEN implantation. CONCLUSION: XEN could be an effective method to reduce IOP after failed TE. The rate of complications seems to be low and the rate of needling procedures and/or revisions is acceptable. Thieme. All rights reserved.
BACKGROUND: Trabeculectomy (TE) has been the standard procedure in glaucoma surgery for a long time. This study examined the efficacy and safety profile of XEN45 Gel Stent (XEN) after failed and/or scarred trabeculectomy. MATERIAL AND METHODS: We analysed all files of patients, who received a XEN after insufficient TE and examined changes in intraocular pressure (IOP), IOP-lowering medication, best corrected visual acuity, visual field tests as well as the intra- and postoperative complications recorded within a 12-month follow-up period. RESULTS: 31 eyes of 28 patients were analysed in our study (mean age: 66,2 ± 13,4 years; 39% female; 48% right eye; mean follow-up after TE: 70,3 ± 64,9 months). The mean IOP decreased from 23,5 ± 6,5 to 18,0 ± 5,3 mmHg (- 23,5% compared to baseline-IOP; p = 0,01) while the mean IOP-lowering medication could be reduced from 2,8 ± 1,1 to 1,1 ± 1,5 (p < 0,01) 12 months after XEN-implantation. The mean visual acuity did not change significantly (pre-op: 0,5 ± 0,6 logMAR; 12 months post-op: 0,5 ± 0,6 logMAR). The most common complications postoperatively were choroideal detachment due to postoperative hypotony in 4 eyes (13%), a needling procedure in 9 eyes (29%), a Re-XEN-Implantation in 4 eyes (13%), an open revision of the conjunctiva in 3 eyes (10%), and a Re-TE in 1 eye (3%) as well as an Ahmed-Valve implantation in 2 eyes (6%). Overall, neither needling procedure nor further glaucoma surgery was necessary in 19 eyes (61%). In 10 of 22 evaluable eyes (45%) an IOP reduction of > 20% was achieved 12 months after XEN implantation. CONCLUSION: XEN could be an effective method to reduce IOP after failed TE. The rate of complications seems to be low and the rate of needling procedures and/or revisions is acceptable. Thieme. All rights reserved.