Cirugía combinada mediante facoemulsificación e implante XEN45 con acceso temporal y 2 únicas incisiones

Pérez-Torregrosa, V.T.; Olate-Pérez, Á.; Cerdà-Ibáñez, M.; Gargallo-Benedicto, A.; Osorio-Alayo, V.; Barreiro-Rego, A.; Duch-Samper, A.

doi:10.1016/j.oftal.2016.02.006

Cited by 98 publications

(35 citation statements)

References 12 publications

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“…Success was defined by eyes achieving ≥ 20% IOP reduction from baseline on the same or fewer medications without glaucoma-related secondary surgical intervention (SSI) or intention to be converted to another procedure. mITT, modified intent-to-treat; phaco, phacoemulsification with intraocular lens replacement studies with this device, including the US pivotal trial in refractory glaucoma [23], as well as independent, retrospective [14,17,18,[24][25][26] and prospective [12,13,15,16,19,[27][28][29] studies in glaucoma, showing effectiveness at 1 year. Among those, a prospective, open-label study of the implant used alone or in combination with cataract surgery (N = 149 eyes) [16] showed that the mean medicated IOP and mean number of medications decreased from 20.0 (7.1) mmHg and 1.9 (1.3) at baseline to 13.9 (4.3) mmHg (P < 0.01) and 0.5 (0.8) (P < 0.001) at 1 year, respectively.…”

Section: Discussionmentioning

confidence: 99%

Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma

Reitsamer

Sng

Vera³

et al. 2019

Graefes Arch Clin Exp Ophthalmol

174

173

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Purpose To evaluate the effectiveness of an ab interno subconjunctival gelatin implant as primary surgical intervention in reducing intraocular pressure (IOP) and IOP-lowering medication count in medically uncontrolled moderate primary openangle glaucoma (POAG). Methods In this prospective, non-randomized, open-label, multicenter, 2-year study, eyes with medicated baseline IOP 18-33 mmHg on 1-4 topical medications were implanted with (phaco + implant) or without (implant alone) phacoemulsification. Changes in mean IOP and medication count at months 12 (primary outcomes) and 24, clinical success rate (eyes [%] achieving ≥ 20% IOP reduction from baseline on the same or fewer medications without glaucoma-related secondary surgical intervention), intraoperative complications, and postoperative adverse events were assessed. Results The modified intent-to-treat population included 202 eyes (of 218 implanted). Changes (standard deviation) in mean IOP and medication count from baseline were − 6.5 (5.3) mmHg and − 1.7 (1.3) at month 12 and − 6.2 (4.9) mmHg and − 1.5 (1.4) at month 24, respectively (all P < 0.001). Mean medicated baseline IOP was reduced from 21.4 (3.6) to 14.9 (4.5) mmHg at 12 months and 15.2 (4.2) mmHg at 24 months, with similar results in both treatment groups. The clinical success rate was 67.6% at 12 months and 65.8% at 24 months. Overall, 51.1 (12 months) and 44.7% (24 months) of eyes were medication-free. The implant safety profile compared favorably with that published for trabeculectomy and tube shunts. Conclusions The gelatin implant effectively reduced IOP and medication needs over 2 years in POAG uncontrolled medically, with an acceptable safety profile. ClinicalTrials.gov registration number: NCT02006693 (registered in the USA).

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Section: Discussionmentioning

confidence: 99%

Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma

Reitsamer

Sng

Vera³

et al. 2019

Graefes Arch Clin Exp Ophthalmol

174

173

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“…At the end of the study, the number of medications decreased by 94.57%. Complications occurred in 3 eyes, 2 eyes had XEN implantation aborted due to surgical difficulties (subconjunctival hemorrhage and XEN extrusion during preparations), while one eye had filtration bleb failure due to encapsulation 5 months after surgery [8]. …”

Section: Discussionmentioning

confidence: 99%

XEN Glaucoma Implant with Mitomycin C 1-Year Follow-Up: Result and Complications

Galal

Bilgic²,

Eltanamly

et al. 2017

Journal of Ophthalmology

154

139

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Purpose. To evaluate gel microstent (XEN, Aquesys, Inc) for treatment of primary open angle glaucoma (POAG). Methods. In this prospective interventional study, 13 eyes with POAG underwent XEN implantation with subconjunctival mitomycin-C. Of those eyes, 3 were pseudophakic and 10 underwent simultaneous phacoemulsification and XEN. Patients had uncontrolled IOP, had intolerance to therapy, or had maximal therapy but undergoing cataract extraction. Follow-up visits included IOP, number of medications, vision, and complications and lasted for 1 year. Complete success was defined as IOP reduction ≥20% from preoperative baseline at 1 year without any glaucoma medications while partial success as IOP reduction of ≥20% at 1 year with medications. Results. IOP dropped from 16 ± 4 mmHg pre-op to 9 ± 5, 11 ± 6, 12 ± 5, 12 ± 4, and 12 ± 3 mmHg at 1 week, 1, 3, 6, and 12 months (p = 0.004, 0.026, 0.034, 0.01, and 0.01, Wilcoxon Signed Ranks) consecutively. BCVA (LogMAR) was 0.33 ± 0.34 and improved to 0.13 ± 0.11 at 1 year. Mean number of medications dropped from 1.9 ± 1 preoperatively to 0.3 ± 0.49 (p = 0.003) at 1 year. 42% of eyes achieved complete success and 66% qualified success. Complications included choroidal detachment in 2 eyes, and implant extrusion in 1 eye, and 2 eyes underwent trabeculectomy. Conclusion. XEN implant is an effective surgical treatment for POAG, with significant reduction in IOP and glaucoma medications at 1 year follow-up.

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“…In the absence of a standard protocol for bleb management, a variety of interventions have been used postoperatively, including reintroduction of antiglaucoma medications in case of IOP increase. The needling rate with the XEN Gel Stent varies widely, [15] from\ 3% with MMC [16,17] to approximately 50% when performed without antimetabolites [18] or with MMC in a few cases [3]. A recent retrospective study reported that needling with 5-FU after XEN implantation resulted in a substantial IOP-lowering effect (preneedling IOP of 26.2 ± 9.5 mmHg and postneedling IOP at last follow-up of 15.4 ± 3.7 mmHg) [19].…”

Section: Discussionmentioning

confidence: 99%

Efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation

et al. 2019

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Purpose To evaluate the efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation. Methods Prospective real-world evidence study included 39 eyes (of 36 patients) with primary openangle glaucoma without previous glaucoma surgery and with uncontrolled intraocular pressure (IOP), glaucoma progression, or intolerance to IOP-lowering therapy. Patients underwent mitomycin C-augmented XEN implantation either as a stand-alone procedure or combined with cataract extraction. 5-Fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria (analogous to pro re nata regimen in age-related macular degeneration treatment). Primary outcome was unqualified success, defined as postoperative IOP \ 18 mmHg and[ 20% reduction from medicated baseline without any antiglaucoma medications and no detected glaucoma progression. Results At median follow-up of 8 months (range 3-24 months), IOP decreased from a medicated baseline value of 23 mmHg (95% CI 21-24 mmHg) to 13 mmHg (95% CI 12-15 mmHg) and number of medications decreased from 3 (95% CI 2-3) to 0 (p \ 0.0001 for both). Median number of 5-fluorouracil injections per eye was 3 (95% CI 2-3), and median time to first injection was 0.5 months (95% CI 0.25-3 months) after surgery. Thirteen eyes (33.3%) underwent C 1 needling, and surgical revision was performed in three cases (7.7%). The primary outcome measure, which allows performing additional procedures, was achieved in 27 eyes (69%). Conclusions 5-Fluorouracil subconjunctival injections are safe and effective in postoperative management of bleb failure after XEN implantation and represent a viable alternative to other methods.

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Cirugía combinada mediante facoemulsificación e implante XEN45 con acceso temporal y 2 únicas incisiones

Cited by 98 publications

References 12 publications

Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma

Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma

XEN Glaucoma Implant with Mitomycin C 1-Year Follow-Up: Result and Complications

Efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation

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