This study aimed to analyze the surgical and refractive outcomes of XEN glaucoma implant (Allergan, an Abbvie company, Irvine, CA, USA), a minimally invasive surgical device for the treatment of operated uncontrolled glaucoma. Eyes that received XEN Gel Stent placement from December 2014 to October 2019 were retrospectively investigated. Intraocular pressure (IOP) change, best-corrected visual acuity (BCVA), change in glaucoma medications, frequency of slit lamp revision procedures, and frequency of secondary glaucoma surgeries were the primary outcomes. Seventy-two eyes of 72 subjects were included in the study: 32 (44%) men and 40 (56%) women. The follow-up period ranged from 1 to 50 months (median, 26.13 months). The mean IOP before surgery was 24.82 ± 8.03 mmHg and decreased to 17.45 ± 5.84 mmHg at the end of the study (mean difference [MD] = −7.48, 95% confidence interval [CI]: −10.04, −4.93;
p
<
0.001
). The mean decrease from baseline was 23%. BCVA before surgery was 0.38 ± 0.30, and that at the end of the follow-up period improved to 0.47 ± 0.37, MD = 0.09, 95% CI: 0.04, 0.13;
p
<
0.001
. Additional procedures (fluorouracil injection and bleb needling) were performed in 11/72 patients (15%). Further glaucoma surgery was necessary for 23.9% of the patients. XEN Gel Stent implantation is both safe and reasonably effective for lowering IOP in operated uncontrolled glaucoma patients.
This retrospective study analyzed the surgical and refractive outcomes of a XEN Gel Implant (Allergan, Abbvie Company, Irvine, CA, USA) in naïve patients versus those with previous glaucoma surgery. We evaluated the efficacy of XEN implantation in 86 glaucoma patients during a long-term follow-up period. Patients were divided into two groups: naïve patients (Group 1) and patients with previous glaucoma surgery (Group 2). Eyes that received a XEN Gel Stent placement from December 2014 to October 2019 were included. Intraocular pressure (IOP) change, corrected distance visual acuity (CDVA), change in glaucoma medications, frequency of slit lamp revision procedures, and frequency of secondary glaucoma surgeries were the primary outcomes. In Group 1, the mean IOP before surgery was decreased significantly from 25.00 ± 7.52 mmHg to 16.83 ± 5.12 mmHg by the end of the study. In Group 2, the mean IOP decreased significantly from 25.35 ± 7.81 mmHg to 17.54 ± 5.34 mmHg. The mean IOP decrease from baseline was 29% in Group 1 and 27% in Group 2 (p = 0.567). There were no significant differences between the groups in the IOP baseline level, the final level, or the change between preoperative and final levels. The qualified success rate for Group 2 was 68.7% versus 76.5% for Group 1 for the initial procedure and 15.4% vs. 20.2%, respectively, for complete success rate (p > 0.05). However, at the end of the follow-up, more patients achieved an IOP < 18 mmHg in Group 1 than in Group 2. Despite the need for more anti-glaucoma medications, repeat XEN Gel implantation appears to show promising results in patients with previously failed anti-glaucoma procedures, owing to its minimal invasiveness.
In the case of SK-gel and T-flux application, PDS demonstrates similar efficacy and safety although the qualified success rate in the case of PDS with T-flux is significantly lower after a 24-month follow-up. The study does not indicate the cause of the observed changes but the nature of the intrascleral lake created by the implants used and its role in IOP regulation may be essential.
Phacoemulsification-deep sclerectomy modified by trabecular microperforations and anterior capsule as a scleral implant lead to an effective decrease in the IOP in medium-term follow-up. The profile of the observed complications indicates that it can be a safe procedure. However, a larger group of patients should be observed to confirm this.
introduCtion. The aim of this study is to present the efficacy and safety of non-penetrating phaco-deep sclerectomy (PDS) with implantation of an absorbable sodium hyaluronate implant (SkGel/Corneal).
MATERIALS AND METHODS.In a prospective case series study 219 procedures were performed on 176 subjects receiving PDS with SkGel implantation. Indications were uncontrolled primary-open angle glaucoma (POAG) and operable cataract. Data collected included best corrected visual acuity (BCVA), intraocular pressure (IOP), and number of hypotensive medications. Follow-up examinations were performed one and seven days after procedure, then one, three, and six months after, and thereafter every six months. Complete and qualified success (without and with hypotensive medications) was assessed for IOP ≤ 18 mm Hg and IOP ≤ 12 mm Hg. resuLts. The mean follow-up was 48.3 ± 12.8 months. At 24 months, mean IOP decreased from 19.9 ± 5.0 mm Hg to 13.4 ± 3.1 mm Hg (P < 0.001) (31.8% reduction) and to 13.3 ± 2.7 mm Hg (P = 0.003) and after 60 months (33.2% reduction). At the 24-month follow-up, the average number of anti-glaucoma medications was reduced from 2.3 ± 0.8 to 0.62 ± 0.88 (p < 0.001). Complete and qualified success rates for IOP ≤ 18 mm Hg were 70.1% and 93.0%, respectively. Goniopuncture (23.8%), suturolysis (20.1%), and needling (18.3%) were performed. The most common complication was transient hypotony (36.07%). ConCLusions. PDS with SkGel leads to an effective decrease in IOP over a long-term follow-up. The profile of the complications indicates that it is a safe procedure.
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