XEN Glaucoma Implant for the Management of Glaucoma in Naive Patients versus Patients with Previous Glaucoma Surgery.
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ABSTRACT:
SUBMITTER: Lewczuk K
PROVIDER: S-EPMC8509378 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:The purpose of this study is to evaluate the efficacy and complications of the XEN implant as a solo procedure or in association with cataract surgery in patients with open angle glaucoma (OAG). All patients who received a XEN implant between June 2017 and June 2018 were included in the study. The primary and secondary outcomes were: the reduction of the intraocular pressure (IOP) at 6 months postoperatively, the decrease of the glaucoma medications 6 months after surgery, the clinical success rate (eyes (%) achieving ≥20% IOP reduction on the same or fewer medications without secondary surgical intervention), the frequency and type of postoperative interventions as well as the complication rate. We included one hundred and seven eyes from 97 patients with primary OAG (79%), or secondary OAG (21%). Seventy-seven patients (72%) received a standalone XEN implantation and 30 (28%) underwent XEN implantation combined with phacoemusification. The IOP decreased from 20.4 mm Hg ± 6.4 preoperatively to 15.4 mm Hg ± 5.3 six months after the surgery, which represented a reduction of 24.5% (P = 1.4.10-7). It was associated with a lowering of glaucoma medications from 2.8 ± 1.0 preoperatively to 0.6 ± 1.0 six months postoperatively (P = 3.6.10-34). The clinical success rate was 67.2% six months after the surgery. The most frequent complications were: IOP spikes >30 mmHg (16.8%), improper position or angled drain (14.0%) and transient minimal hyphema (<1 week) (11.2%). During the follow-up, the needling was required in 34.6% of cases and a total of 10 eyes (9.4%) required a new glaucoma surgery. To conclude XEN implantation appears to be an effective short- and mid-term surgical technique to control IOP in OAG with a low risk of complication. However postoperative maneuvers were frequently required to maintain efficiency.
| S-EPMC7066242 | biostudies-literature
Project description:To assess the efficacy of XEN-implant surgery in patients with glaucoma, and to perform a meta-analysis of previously published results and compare these to our data. Prospective case-control study, in which all eyes that underwent XEN-implant surgery were included from 2015 onwards. Sub-analyses were performed for eyes that underwent XEN-implant as standalone procedure and as cataract-combined procedure. To compare our results, a systematic review was performed using the Embase, PubMed, Web of Science, and Cochrane database. Meta-analyses were performed by combining data (intraocular pressure (IOP), IOP-lowering medication, and complications) from the retrieved studies. A total of 221 eyes underwent XEN-implant surgery (124 standalone and 97 cataract-combined). The mean ± standard deviation IOP declined from 18.8 ± 6.5 to 13.5 ± 4.3 mmHg at the last follow-up (p < 0.001; 28.9%). Postoperative, no significant differences in IOP or IOP-lowering medication were found between patients with and without combined procedure. Secondary surgeries were performed in 20.8% of eyes, most of them (63.0%) within six months. A meta-analysis of 19 studies retrieved from the systematic review showed a two-years postoperative pooled mean (weighted mean difference) of 14.5 (7.3) mmHg and 1.0 (1.6) for IOP and IOP-lowering medications, respectively (compared to 13.5 (5.3) mmHg and 3.2 (2.4) in the current study). XEN-implant surgery was effective and safe in lowering IOP and the number of IOP-lowering medications. There were no differences between standalone and combined procedures.
| S-EPMC7962186 | biostudies-literature
Project description:This study evaluated the long-term surgical outcomes of Baerveldt glaucoma implant (BGI) surgery in patients with refractory glaucoma (204 eyes/204 patients). Surgical failure was defined by: < 20% reduction in preoperative intraocular pressure (IOP), or criterion A (IOP > 21 mmHg), criterion B (IOP > 17 mmHg), or criterion C (IOP > 14 mmHg). Reoperation, loss of light perception vision, or hypotony also denoted failure. The probability of success at 5 years postoperatively using criteria A, B, and C was 72.4%, 49.7%, and 24.4%, respectively. The mean IOP decreased significantly from 32.7 ± 9.7 mmHg preoperatively to 13.1 ± 3.9 mmHg at 5 years; the mean number of glaucoma medications also decreased from 3.7 ± 1.2 to 1.8 ± 1.9 (both P < 0.01). The number of previous intraocular surgeries was significantly associated with failure in the multivariable analysis for criterion B (hazard ratio 1.30; P < 0.01) and criterion C (hazard ratio 1.19; P = 0.031). Early and late postoperative complications occurred in 82 (40.2%) and 28 (13.7%) eyes, respectively. Postoperative interventions were performed in 44 eyes (21.6%). BGI surgery resulted in significant long-term decreases in IOP and the number of glaucoma medications. BGI surgery is effective for refractory glaucoma. However, postoperative interventions due to complications are required in numerous cases.
| S-EPMC10471744 | biostudies-literature
Project description:AimTo compare clinical outcomes between Ahmed glaucoma implant (AGV-S2 and FP7 models) and Baerveldt-350 glaucoma implant (BGI).DesignProspective randomized study.Methods and subjectsEighty-one participants with glaucoma after ocular surgery or secondary glaucoma with persistent and uncontrolled IOP > 21 mmHg were randomized for placement of BGI or AGV models using a standardized surgical technique. The primary outcome was failure, which was defined as IOP >16 mmHg with glaucoma medication, on 2 consecutive study visits. Secondary outcomes were IOP, medication use, visual acuity, complications, and interventions.ResultsAt one-year follow up, the mean IOP was 14.76±2.5 mmHg in BGI group and 16.57±3.35 mmHg in AGV group (P=0.015). The mean number of glaucoma medications in use was 1.6±0.81 in the BGI group and 3.91±0. 0.28 in the AGV group (P <0.001). There was 1.81 mmHg difference in the mean IOP between participants in both groups with 0.85 SD difference. At 12 months, the failure rate was 11/56 (19.67%) in AGV group and 3/25 (12%) in BGI group (P=0.352). The VA was stable in 77% in the BGI group (P=0.93) versus 80% of patients in AGV group (P=0.88). No significant change was observed in logMAR Snellen VA between both groups (P=0.254). None of the patients lost light perception.ConclusionBoth the Ahmed valve implant and the Baerveldt implant are effective in reducing preoperative IOP and glaucoma medications in patients with refractory glaucoma. This trial cannot give clear clinical proof for valve superiority over the other. The Baerveldt-350 implant can be a good choice for refractory glaucoma cases. Capsular scarring around the plate is considered as the main factor for surgical failure and resistant IOP.Trial registrationThe trial was registered with the Research Ethical Committee, Ain Shams University, FWA 000017585 FMASU 21/2017, and registered at Clinical Trial. gov: NCT04215575.
| S-EPMC6955622 | biostudies-literature
Project description:PURPOSE:The Xen® Gel Stent (Allergan, Irvine, CA, USA) is a minimally invasive glaucoma surgery device implanted to reduce intra-ocular pressure (IOP) in glaucoma. The stents can fail to drain post-operatively due to scarring of the conjunctiva around the stent opening. Data on the success rates of revision surgery in patients with Xen stent failure are scarce. We present the first detailed report of the steps, outcomes and complications of Xen revision surgery with 12 months of follow-up data. METHODS:We share our experiences on the circumstances in which to perform Xen revision surgery, the steps of the surgery and the results of a retrospective interventional case series of all Xen revisions performed at a single centre from 2013 to 2018. RESULTS:A total of 151 Xen implants were inserted into eyes at our tertiary centre during the study period, of which 21 eyes (patients) underwent revision surgery. Mean pre-operative IOP was 26.1 (standard deviation 8.3) mmHg with the patient on two drops of anti-glaucoma medication. Four patients were excluded from the analysis due to incomplete data (medical records were unavailable for 2 patients; 1 patient died shortly after surgery; and 1 patient moved to another area). A non-functioning Xen implant was identified in another patient during revision surgery, and the procedure was converted to a trabeculectomy. The remaining 16 patients were included in the analysis, all of whom had a minimum follow-up of 12 months, with the longest follow-up being 4 years following revision surgery. Of these 16 patients, four required needling and 5-fluorouracil injection in the first 12 months following revision surgery, three required further glaucoma drainage surgery due to the failure of the revision surgery to control IOP in the first year and one suffered bleb-related endophthalmitis at the site of previous trabeculectomy surgery. Mean IOP at 12 months following revision surgery was 16.3 (standard deviation 3.7) mmHg on 0.7 drops of anti-glaucoma medication, which equates to a 37.5% reduction in IOP and a 65% reduction in the amount of IOP-lowering drops required. CONCLUSION:Our study shares experience on when to perform Xen revision surgery and the steps required. The results of our small cohort are the first in the literature and show that revisions can achieve promising IOP and medication reductions. Some patients still require needling in the post-operative period to optimise outcomes.
| S-EPMC7054468 | biostudies-literature
Project description:This study aimed to evaluate the 3-year long-term outcomes of primary Baerveldt glaucoma implant (BGI) surgery for neovascular glaucoma (NVG). We retrospectively evaluated 27 consecutive patients with NVG between November 2013 and November 2017. All the patients were treated with panretinal photocoagulation and pars plana vitrectomy before BGI surgery without anti-vascular endothelial growth factor treatment. The surgical success of the BGI was defined as an IOP of <22 mmHg and <5 mmHg with or without antiglaucoma medication. The outcomes were assessed on the basis of intraocular pressure (IOP), visual acuity, postoperative complications, and cumulative success rate. Except for 2 mortality cases, 25 eyes (92.6%) were followed up for 3 years. The mean IOPs (mmHg)/numbers of glaucoma medications ± standard error of the mean before and 12 and 36 months after BGI surgery were 41.6/4.6 ± 1.9/0.2, 14.8/2.2 ± 0.8/0.4 and 16.9/2.6 ± 1.1/0.3, respectively. In all of the follow-up time points, the postoperative mean IOP and number of glaucoma medications were statistically significantly lower than the preoperative values (analysis of variance, P < 0.001). At 3 years after surgery, the rates of visual acuity improvement (logMAR ≤ -0.3), invariance (-0.3 < logMAR < 0.3), and worsening (logMAR ≥ 0.3) were 56.0% (14/25 eyes), 24.0% (6/25 eyes), and 20.0% (5/25 eyes), respectively. The most common postoperative complications were hyphema (4 eyes, 14.8%) and vitreous hemorrhage (5 eyes, 18.5%), and serious complications such as expulsive hemorrhage, endophthalmitis, and tube/plate exposure did not occur. The cumulative probabilities of surgical success after the operation were 100% at 1 year, 85.2% at 2 years, and 77.4% at 3 years. In conclusion, combined non-valved pars plana tube placement in conjunction with vitrectomy was successful at lowering IOP with relatively low complication rates.
| S-EPMC8049227 | biostudies-literature
Project description:PurposeTo report here a case of uncontrolled glaucoma during third-trimester of pregnancy that was treated successfully with bilateral Xen gel stent insertion.ObservationsA 35-year-old woman presented during the third trimester of pregnancy with bilateral uncontrolled primary open angle glaucoma. Her disc examination and visual fields were consistent with advanced glaucoma. After failed Selective Laser Trabeculoplasty and maximal medical treatment, including Acetazolamide, she was treated with bilateral consecutive Xen stent surgery with successful control of her intraocular pressure.Conclusions and importanceThe use of Xen implant may have advantages over traditional trabeculectomy, especially during pregnancy, as the procedure is shorter, with less dependence on on-table antimetabolite and being minimally invasive with sparing of the conjunctiva.
| S-EPMC6637221 | biostudies-literature
Project description:PURPOSE:This study examines the incidence of visually significant cystoid macular edema (CME) after glaucoma drainage implant (GDI) surgery and analyses risk factors associated with developing CME and prognosis with treatment. MATERIALS AND METHODS:In total, 185 eyes from 185 glaucoma patients (mean age, 72.46±13.94 y) who underwent GDI surgery at a tertiary eye institute were recruited. Patients were classified based on the presence (CME) or absence (No-CME) of CME. Pre-GDI and post-GDI best-corrected visual acuity, number of intraocular pressure (IOP)-lowering medications, IOP, standard automated perimetry and post-GDI complications, were recorded and compared between the 2 groups. Optical coherence tomography (OCT) was used to quantify retinal thickness and monitor CME. RESULTS:In total, 41 (22.2%) eyes developed visually significant CME after GDI surgery. Patients with CME had a higher incidence of pre-GDI nonsteroidal anti-inflammatory drug (P<0.01) use and higher number of prior glaucoma surgeries (P<0.01). CME patients had a higher (P<0.01) incidence of iritis, epiretinal membrane, and hypotony. CME eyes responded well to steroids, with resolving macular edema (458.4±151.9 vs. 322.0±92.0 µm, P<0.01) and improving visual acuity (0.73±0.48 vs. 0.56±0.56 logarithm of minimum angle of resolution, P<0.01). Both CME and non-CME groups had equivalent lowering of IOP and post-GDI glaucoma medications; with no significant elevation in IOP in the steroid-treated CME group. CONCLUSIONS:Post-GDI surgery visually significant CME rates are potentially higher in a real hospital scenario compared with controlled clinical trials. With diligent treatment, CME resolves effectively restoring visual acuity and central macular thickness.
| S-EPMC5790635 | biostudies-literature
Project description:PurposeTo explore patients' perspectives and experiences living with moderate to severe glaucoma through qualitative, semistructured interviews and to identify important benefits and risks that patients consider when choosing glaucoma treatments.DesignSemistructured, in-person qualitative interviews with a convenience sample of patients seen at the Johns Hopkins Wilmer Eye Institute.ParticipantsSurgery-naive patients 21 years of age or older with moderate to severe open-angle glaucoma seeking treatment at the Wilmer Eye Institute's Glaucoma Center of Excellence between August and December 2018.MethodsWe conducted semistructured interviews with patients diagnosed with moderate to severe open-angle glaucoma, focusing on outcomes they prioritize when considering various treatment options. We used Atlas.ti software version 7.5.12 (Scientific Software Development GmbH, Berlin, Germany) to process interview transcripts and the framework approach to analyze the qualitative data.Main outcome measuresPatients' descriptions of outcomes important to them in management of moderate to severe open-angle glaucoma.ResultsThirteen men and 15 women with a median age 67 years participated in the study. Compared with the mild-to-moderate glaucoma patients interviewed previously, these participants similarly emphasized (1) activities of daily living, (2) visual symptoms, (3) treatment burden, and (4) intraocular pressure (IOP) control, but unlike patients with milder disease, most related IOP control directly to (5) avoiding disease progression. Almost all (27/28) had also given significant thought to (6) surgical decision making and could describe how they would decide for or against a particular procedure. Finally, two thirds (18/28) expressed (7) significant fear and worry related to their glaucoma diagnosis.ConclusionsWe identified outcomes that matter to patients who are undergoing treatment for moderate to severe glaucoma, many of which may serve as end points in clinical trials, such as functional independence in vision-dependent activities of daily living, avoidance of visual symptoms, and disease progression via maintenance of IOP control. We also observed that these patients have varied and nuanced perspectives on surgical management and its outcomes. It behooves providers and trial designers to consider these in future evaluations of new treatments for moderate to severe glaucoma.
| S-EPMC7529737 | biostudies-literature
Project description:BackgroundColonic capsule endoscopy (CCE) derived from the video capsule endoscopy, initially proposed to explore the small bowel, has demonstrated high sensitivity and specificity for colonic polyp detection. The primary outcome of the study was to assess the safety, feasibility, and reliability of CCE after colorectal surgery. Secondary outcomes were to identify the detection rate of colonic lesions and recognition of the surgical anastomosis as compared to colonoscopy.MethodsThis is a prospective single-center study conducted over a 2-year period. Thirty-seven patients with a history of colorectal surgery were prospectively included in this study. Each patient received both CCE and colonoscopy, performed by different operators blinded to each other's results.ResultsThirty-two patients (86.5%) completed the study and were included in the final analysis. All capsules were naturally expelled. In three patients (9.4%), the anal verge was not identified during the CCE recording and the examination of the colon was considered incomplete. Surgical anastomosis was accurately identified by CCE in 78.2% of the patients versus 93.8% for colonoscopy (P = 0.65). Thirty-eight lesions were detected in 14 patients. The sensitivity of CCE to detect colonic polyps was 95.2% (95% confidence interval (CI): 77.3-99.2%), the specificity 82.4% (95% CI: 59.0-93.8%). Positive predictive value (PPV) and negative predictive value (NPV) of CCE to detect colonic polyps were 87.0% and 93.3%, respectively. No complications related to the passage of the capsule through the intestinal anastomosis were detected.ConclusionsCCE proved to be safe and feasible, reporting a similar detection rate of colonic lesion compared to colonoscopy.
| S-EPMC7665853 | biostudies-literature