Efficacy and safety data for the Ab interno XEN45 gel stent implant at 3 Years: A retrospective analysis

2021 ◽  
pp. 112067212110143
Author(s):  
Itay E Gabbay ◽  
Mordechai Goldberg ◽  
Felicity Allen ◽  
Zhiheng Lin ◽  
Christine Morley ◽  
...  

Purpose: To report efficacy and safety measures of the XEN45 gel stent at 36 months in the UK National Health Service setting. Methods: Retrospective non-comparative audit of the records of patients who underwent XEN45 implantation between June 2015 and May 2017 was performed. Main outcome measures were intraocular pressure and number of antihypertensive medications used. Failure was defined as need for further surgery or stent removal. Success was defined as a 20% decrease in intraocular pressure without the need for additional glaucoma medications or a reduction in antihypertensive medications without an increase in baseline intraocular pressure. Needling rates and preoperative factors effect were assessed. Results: The cohort included 205 patients (205 eyes) with primary open angle glaucoma (84.4%), angle closure glaucoma (7.8%), or refractory glaucoma (7.8%), 62.9% had a stand-alone procedure and 37.1%, a combined phaco-XEN45 procedure. Mean intraocular pressure was 22.6 ± 7.0 mmHg at baseline compared to 14.7 ± 3.8 mmHg at 24 months and 14.0 ± 2.9 mmHg at 36 months ( p < 0.001 for both). Mean number of medications used was 2.6 ± 1.1 at baseline compared to 0.5 ± 0.9 and 0.6 ± 1.0, at 24- and 36-months, respectively ( p < 0.001 for both). The failure rate at 36 months was 25%. Needling was required in 36.6%. Evaluation of background factors yielded an increased failure rate in non-Caucasians compared to Caucasians (74% vs 21%, p < 0.001). Conclusion: XEN45 implantation is effective and safe at 36 months’ follow-up. Patients should be advised regarding the risk of failure and possible need for bleb revisions. Careful patient selection may be required.

2019 ◽  
Vol 104 (8) ◽  
pp. 1125-1130 ◽  
Author(s):  
Itay Elimelech Gabbay ◽  
Felicity Allen ◽  
Christine Morley ◽  
Tahmina Pearsall ◽  
Oliver Martyn Bowes ◽  
...  

AimTo report efficacy and safety measures for XEN45 in a National Health Service setting after 24-month follow-up.MethodsThis is a retrospective, non-comparative audit of records of patients who underwent XEN45 procedure between June 2015 and May 2017. The main outcome measures were intraocular pressure (IOP) reduction and number of antihypertensive medications at each timepoint. Failure was defined as requiring further surgery or removal of XEN. Success was defined as 20% reduction of IOP without additional glaucoma medications or reduction in antihypertensive medications without increase in baseline IOP. Needling rates were assessed and subgroup analysis was performed.ResultsA total of 151 eyes were included in the study. The main diagnoses were primary open angle glaucoma (84.1%), angle closure glaucoma (8.6%) and refractory glaucoma (7.3%). Stand-alone procedure was performed in 62.3% and combined phaco-XEN was done in 37.7%. The mean IOP at baseline was 22.1±6.5 mm Hg, and the mean IOP at 12 and 24 months was 15.4±5.9 mm Hg and 14.5±3.3 mm Hg, respectively (p<0.001). The mean number of medications was 2.77±1.1 at baseline, and 0.3±0.7 and 0.5±1.0 medications at 12 and 24 months, respectively (p<0.001). 25% of patients failed at the 24-month timepoint. Needling was required in 37.7% of patients at 24 months. Non-Caucasian ethnicity was found to be related to higher failure rate. No significant adverse events were noted.ConclusionXEN45 is a viable, effective and safe procedure after 2 years of follow-up. Patients should be advised regarding failure rate as well as possible need for bleb revisions and medication use.


2019 ◽  
Vol 30 (4) ◽  
pp. 700-705 ◽  
Author(s):  
Alexander T Nguyen ◽  
Jessica Maslin ◽  
Robert J Noecker

Purpose: To describe our clinical experience with the efficacy and safety of micropulse transscleral cyclophotocoagulation as a treatment for glaucoma. Methods: In this retrospective case series, we reviewed the charts of 95 consecutive patients with various glaucoma subtypes who underwent micropulse transscleral cyclophotocoagulation. Patients were offered micropulse transscleral cyclophotocoagulation if they had perimetric glaucoma refractory to intraocular pressure–lowering topical medications and who were poor candidates for traditional filtering surgery. Eligible patients were treated with the Micropulse P3 device (IQ 810 Laser Systems; Iridex, Mountain View, CA, USA) at 2.0–2.5 W for a duration of 90 s per hemisphere at a 31.3% duty cycle. If a retreatment was needed, the power was increased to up to 3.0 W with other parameters remaining the same. Patients were considered successfully treated if their intraocular pressure was lowered by at least 20% compared to their baseline. The main outcome measure was post-operative intraocular pressure; secondary outcome measures included the number of adverse events and complications that occurred with treatment. Results: The glaucoma subtypes treated included primary open-angle glaucoma (n = 51), exfoliation glaucoma (n = 24), chronic angle-closure glaucoma (n = 15), and congenital/juvenile glaucoma (n = 5). The mean pre-operative intraocular pressure was 25.1 ± 5.3 mm Hg and the mean post-operative intraocular pressure at 12 months was 17.5 ± 5.1 mm Hg (p = 0.004). The mean number of intraocular pressure–lowering medications used preoperatively was 3.0 ± 1.1; the mean number of medications used at the 12-month post-operative visit was 1.4 ± 1.0 (p = 0.03). Success with one treatment was achieved in 73 (76.8%) of patients. With multiple treatments, all patients had significant intraocular pressure–lowering compared to baseline. The maximum number of treatments received by any single patient was 5. There were no instances of prolonged intraocular inflammation or long-term hypotony. Conclusion: Micropulse transscleral cyclophotocoagulation appears to be a safe and efficacious treatment for glaucoma. Given its improved safety profile compared to continuous-wave transscleral cyclophotocoagulation, it deserves consideration as a primary procedure.


2011 ◽  
Vol 139 (1-2) ◽  
pp. 12-17
Author(s):  
Marija Bozic ◽  
Paraskeva Hentova-Sencanic ◽  
Djordje Kontic ◽  
Vujica Markovic ◽  
Ivan Marjanovic

Introduction. Argon laser trabeculoplasty (ALT) is an intraocular pressure lowering method that is overall safe and powerful, but often complicated by transient postoperative intraocular pressure rises. In prevention of this complication, we frequently use two potent alpha-adrenergic agonists - brimonidine and apraclonidine. Objective. The aim of this study was to compare brimonidine 0.2% and apraclonidine 0.5% efficacy and safety in prevention of intraocular pressure elevation after ALT. Methods. This was a prospective, randomized, double-masked and comparative study. This study included 27 POAG patients, 15 received 0.2% brimonidine, and 12 received 0.5% apraclonidine before laser surgery (22 eyes in both groups). Intraocular pressure readings were taken 1, 2, 3, 24 hours and 7 days after ALT. Student?s t-test was used to analyze data between two groups, and ?2 test to compare data within groups. Value p less than 0.05 was considered statistically significant. Results. We found statistically significantly lower IOP in eyes that received 0.2% brimonidine at readings taken 1 hour after ALT (p=0.001). There were no statistically significant differences in other IOP readings between two groups. Conclusion. A single preoperative drop of brimonidine 0.2% had similar efficacy and safety as apraclonidine 0.5% in preventing transient IOP elevations after ALT.


2020 ◽  
Vol 37 (1) ◽  
Author(s):  
Shua Azam ◽  
Abdul Hameed Talpur ◽  
Mahak Shaheen ◽  
Sadia Bukhari

Purpose:  To determine the change in intraocular pressure after cataract surgery in patients diagnosed with glaucoma. Study Design:  Interventional case series. Place and Duration of Study:  Glaucoma Clinic. Al-Ibrahim Eye Hospital (AIEH) Karachi, Pakistan from May to October, 2019. Methods:  Thirty-eight patients diagnosed with glaucoma and cataract and registered in glaucoma clinic were recruited for this study. Inclusion Criteria was age > 41 years and patients diagnosed with primary open/closed angle glaucoma and cataract. Patients with secondary glaucoma, history of trabeculectomy and any other ocular diseases were excluded from the study. Pre-operative assessment was done for phacoemulsification. In post-operative examination, first and second follow-up IOP was measured. Data analysis was done on statistical package for social science (SPSS) version 20.0. Statistical changes were present in the form of bar chart, frequency and graphs. The mean standard deviation for pre-operative, post-operative 1st and 2nd follow-up IOP was calculated. Results:  A total of 38 participants and 48 eyes satisfied the inclusion criteria. Out of 48 eyes, 39 (81.3%) eyes were diagnosed with Primary open angle glaucoma and 9 (18.8%) eyes with Primary Angle Closure Glaucoma. The pre-operative mean IOP was 16.56 ± 6.67 mm Hg and post-operative mean IOP at first follow-up was 13.39 ± 4.04 mm Hg. At second follow-up at one-month mean IOP was 12.14 ± 2.28 mm Hg. Conclusion:  Phacoemulsification produces a useful decrease in IOP in glaucoma patients. Key Word:  Glaucoma, Cataract, Phacoemulsification, Intraocular Pressure.


2013 ◽  
Vol 5 (1) ◽  
pp. 75-80 ◽  
Author(s):  
Ashish Chander ◽  
H Kapoor ◽  
S Thomas

Purpose: To compare the efficacy and safety of bimatoprost (0.03 %) and travoprost (0.004 %) in patients with primary open angle glaucoma (POAG). Subjects and methods: Patients with POAG were randomized to receive either bimatoprost or travoprost once daily. Detailed ocular examination was done and intraocular pressure (IOP) was measured at 9.00 am, 1.00 pm and 4.00 pm at the baseline and at 1, 2, 4, 6 and 12 weeks of therapy. Results: A total of 31 patients were analysed. The patients were randomly divided into two groups (Bimatoprost group = 16; Travoprost group = 15). Both the groups had a statistically significant reduction from the baseline IOP at all follow up visits at 9.00 am, 1.00 pm and 4.00 pm. The mean IOP decreased from a baseline of 25 ± 2.32 mm Hg to 15.93 ± 1.79 mm Hg after 12 weeks in the bimatoprost group (p < 0.001), and from 24.2 ± 1.60 mm Hg to 16.53 ± 1.56 mm Hg in the travoprost group (p < 0.001). A better mean reduction of IOP was obtained with bimatoprost than with travoprost at the end of the study at 12 weeks (p = 0.03). Mild ocular redness was the commonest side effect in both the groups but was not significant in either group. Conclusion: Both drugs lowered IOP effectively but bimatoprost showed a greater reduction in the mean IOP than did travoprost at 12 weeks and both are safe for ocular use. Nepal J Ophthalmol 2013; 5(9):75-80 DOI: http://dx.doi.org/10.3126/nepjoph.v5i1.7831


2020 ◽  
pp. 112067212097360
Author(s):  
Zhou Longfang ◽  
Hu Die ◽  
Lan Jie ◽  
Liu Yameng ◽  
Lv Mingyuan ◽  
...  

Purpose: To evaluate clinical efficacy and safety of single Ultrasound Cyclo-Plasty (UCP) in the treatment of advanced refractory glaucoma. Methods: From January 2018 to August 2018, 25 patients (25 eyes) with refractory glaucoma and intraocular pressure (IOP) not controlled by drugs or conventional filtering surgery were included in the study. All subjects (neovascular glaucoma [ n = 12], secondary glaucoma [ n = 6], angle closure glaucoma [ n = 6], and primary open angle glaucoma [ n = 1]) underwent 8-sector Ultrasound Cyclo-Plasty. Patients were followed-up at Day 1, Week 1, and at 1, 3, 6, and 12 months, during which the IOP, the number of IOP lowering drugs and the occurrence of ocular complications were recorded. Clinical outcomes were IOP reduction, success rate, and ocular complications. According to the glaucoma type, patients were divided into a neovascular group (NVG) and a non-NVG group for sub-analysis. Results: All patients underwent a single UCP procedure and mean IOP reduced significantly from 39.7 ± 6.1 mmHg before UCP to 27.1 ± 11.0 mmHg at 1 year ( p < 0.01) corresponding to a mean IOP reduction of 29.6%. The mean number of IOP-lowering drugs used was 2.4 ± 1.2 at baseline and 2.3 ± 1.0 at 12 months. Success rate after a single UCP procedure was achieved in 41.7% patients at 1 year, with a higher success rate in non-NVG than in the NVG group. No major postoperative complications were reported. The main complication was conjunctival congestion, anterior chamber inflammation, scleral ring congestion, and scleral inprint. Of these, scleral ring congestion and scleral imprint are relatively rare complications, which can still be observed 12 months after UCP treatment. Conclusion: UCP for refractory glaucoma is effective in reducing IOP and has a good safety profile. Success rate is lower after a single UCP in NVG than for other types of glaucoma.


2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Sarah C. Xu ◽  
Angela C. Gauthier ◽  
Ji Liu

Glaucoma is one of the leading causes of blindness worldwide. Recent studies suggest that intraocular pressure (IOP) fluctuations, peaks, and rhythm are important factors in disease advancement. Yet, current glaucoma management remains hinged on single IOP measurements during clinic hours. To overcome this limitation, 24-hour IOP monitoring devices have been employed and include self-tonometry, permanent IOP, and temporary IOP monitoring. This review discusses each IOP measuring strategy and focuses on the recently FDA-approved contact lens sensor (CLS). The CLS records IOP-related ocular patterns for 24 hours continuously. Using the CLS, IOP-related parameters have been found to be associated with the rate of visual field progression in primary open-angle glaucoma, disease progression in primary angle-closure glaucoma, and various clinical variables in ocular hypertension. The CLS has been used to quantify blink rate and limbal strain and measure the circadian rhythm in a variety of disease states including normal-tension glaucoma and thyroid eye disease. The effects of various IOP-lowering interventions were also characterized using the CLS. CLS provides a unique, safe, and well-tolerated way to study IOP-related patterns in a wide range of disease states. IOP-related patterns may help identify patients most at risk for disease progression and assist with the development of tailored treatments.


2013 ◽  
Vol 2013 ◽  
pp. 1-4 ◽  
Author(s):  
Nihat Sayin ◽  
Zeynep Alkin ◽  
Abdullah Ozkaya ◽  
Abdulvahit Demir ◽  
Ahmet Taylan Yazici ◽  
...  

Purpose. To investigate the efficacy and safety of 360° selective laser trabeculoplasty (SLT) on medically uncontrolled open-angle glaucoma (OAG) and to evaluate the effects of antiglaucomatous medications on the results of therapy. Materials and Methods. The medical records of 62 eyes of 51 patients with OAG, which did not reach the targeted intraocular pressure (IOP) with maximum antiglaucomatous medical therapy, were retrospectively reviewed. Results. A statistically significant decrease was observed in the mean baseline IOP at 1, 3, 6, and 12 months of followup (P<0.01). The success rate was 64.5% in all of the patients. The success rates did not vary significantly by taking 1, 2, 3, or 4 medications with the rates of 63.6%, 71.4%, 64.2%, and 58.3% (P=0.06). The success rate of eyes on medication more or less than 6 months was 62.5% or 66.7%, respectively (P=0.3). There was a positive correlation between mean baseline IOP and mean reduction in IOP from baseline (P<0.001, r=0.8). Conclusion. Application of 360° of SLT provided an effective and safe IOP reduction in medically uncontrolled OAG. Baseline IOP was found to be the most important factor in the efficacy of therapy.


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