Dataset Information

Treatment of Open-Angle Glaucoma with iStent Implantation Combined with Phacoemulsification in Polish Caucasian Population.

ABSTRACT:

Purpose

The aim of this investigation was to evaluate the impact of iStent (the first-generation trabecular bypass) implantation with phacoemulsification on the intraocular pressure (IOP) and glaucoma medication in subjects with mild to moderate open-angle glaucoma (OAG) and cataract in a Polish Caucasian population.

Patients and methods

This prospective case series covered 78 eyes of (57 Polish Caucasian patients) that had undergone iStent implantation in conjunction with cataract surgery. Patients were surveyed preoperatively and at postoperative day 1, week 1, and months 1, 3, 6, 12, and 24. Pre- and postoperative outcome measurements included visual acuity, IOP, and medication burden. Intraoperative and postoperative complications were noted for the safety profile. For effective treatment, an IOP reduction ?20% was assumed, regardless of the use of IOP-lowering drops. Complete surgical success was defined as an IOP ? 15 mmHg, medications free, and a qualified surgical success as IOP ? 15 mmHg with or without medications.

Results

Post-operatively at two years, mean IOP reduced from 18.5 mmHg to 16.1?mmHg. The mean medication burden dropped from 1.8 to 0.4 at the end of follow-up. Preoperatively, 2 (2.6%) eyes were medication free, but by postoperative month 24, 53 (68%) eyes were medication-free (p < 0.05). Effective treatment was achieved in 50 cases (64%) at the end of follow-up period. Kaplan-Meier cumulative incidence of qualified success was 51.9% after 24 months, CI₉₅ [41.9%; 64.4%], while cumulative incidence of complete success after 2 years of observation was 35.1%, CI₉₅ [25.9%; 47.5%].

Conclusion

The iStent device combined with a cataract surgery served to decrease, significantly and positively, both IOP and medication use in the 24-months follow-up in patients with coexistent OAG and cataract in Polish patients.

SUBMITTER: Kozera M

PROVIDER: S-EPMC7882442 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Treatment of Open-Angle Glaucoma with iStent Implantation Combined with Phacoemulsification in Polish Caucasian Population.

Kozera Milena M Konopińska Joanna J Mariak Zofia Z Rękas Marek M

Clinical ophthalmology (Auckland, N.Z.) 20210210

<h4>Purpose</h4>The aim of this investigation was to evaluate the impact of iStent (the first-generation trabecular bypass) implantation with phacoemulsification on the intraocular pressure (IOP) and glaucoma medication in subjects with mild to moderate open-angle glaucoma (OAG) and cataract in a Polish Caucasian population.<h4>Patients and methods</h4>This prospective case series covered 78 eyes of (57 Polish Caucasian patients) that had undergone iStent implantation in conjunction with catarac ...[more]

PMID: 33603324

Similar Datasets

Project description:ObjectivesTo compare the efficacy and safety of two Schlemm's canal-based microinvasive glaucoma surgery (MIGS) devices, the Hydrus Microstent and the iStent Trabecular Bypass combined with phacoemulsification for treatment of open-angle glaucoma.DesignSystematic review and network meta-analysis.MethodsLiterature searches were conducted on PubMed, Web of Science, Cochrane Library and ClinicalTrials.gov to identify randomised controlled trials (RCTs) assessing the Hydrus or the iStent implantation combined with phacoemulsification for treatment of open-angle glaucoma until September 2020. Risk of bias was assessed using a six-item modified Jadad scale. Effects were estimated using the intraocular pressure (IOP) reduction (IOPR), the percentage of IOPR and the proportion of medication-free patients at follow-up end. Safety was estimated using the proportions of adverse events. The network meta-analysis was conducted within a Bayesian framework using the Markov Chain Monte Carlo method in ADDIS software.ResultsSix prospective RCTs comprising 1397 patients were identified. Regarding the absolute value and the percentage of IOPR, the Hydrus and 2-iStent implantation combined with phacoemulsification were significantly more effective than phacoemulsification alone. Rank probability analysis revealed the Hydrus might be the best choice to lower IOP. There was no significant difference in the proportion of medication-free patients among groups. The Hydrus and 2-iStent implantation had a higher probability to achieve the medication-free status versus the 1-iStent implantation and phacoemulsification alone. Overall safety profiles were good for each device with the focal peripheral anterior synechiae more frequently reported in Hydrus eyes.ConclusionsThe Hydrus implantation may have a slight advantage over the 1-iStent or 2-iStent implantation in combination with phacoemulsification to treat open-angle glaucoma. Our findings might be of some uncertainty due to the limited included data. Further studies are needed to investigate whether our findings are robust, including high-quality RCTs to directly compare these MIGS devices.

Project description:BackgroundThe short- and medium-term outcomes of iStent have been extensively studied; however, only few studies have investigated its long-term outcomes. Here, we assessed the long-term efficacy and safety of two iStents with concomitant cataract surgery in glaucomatous eyes while also evaluating measures of disease stability using visual field and optical coherence tomography (OCT) of the optic nerve and the macula throughout 8 years of follow-up.MethodsThis longitudinal, single-center consecutive case series included glaucomatous eyes that underwent implantation of two first-generation trabecular micro-bypass stents (iStent) with concomitant cataract surgery. Eight-year efficacy outcomes included mean intraocular pressure (IOP) and medications, as well as surgical success. Eight-year safety outcomes included best-corrected visual acuity (BCVA), visual field mean deviation (VF-MD), cup-to-disc ratio (CDR), retinal nerve fiber layer (RNFL) thickness, ganglion cell-inner plexiform layer (GC-IPL) thickness, and adverse events.ResultsA total of 62 eyes with primary open-angle glaucoma (POAG) were included. At 8 years postoperative, IOP reduced by 26% from 19.2 ± 3.9 mmHg preoperatively to 14.2 ± 2.4 mmHg (P < 0.001), 91.1% of eyes achieved IOP ≤ 18 mmHg (vs. 51.6% preoperatively), 69.6% of eyes achieved IOP ≤ 15 mmHg (vs. 14.5% preoperatively), and 25% of eyes achieved IOP ≤ 12 mmHg (vs. 1.6% preoperatively). Medication use decreased by 17.9% from 2.8 ± 1.1 preoperatively to 2.3 ± 1.2 (P = 0.018). Surgical success was 90%, as six eyes underwent subsequent glaucoma surgeries. Safety measures of BCVA, CDR, RNFL thickness and GC-IPL thickness remained stable through 8 years postoperative. VF-MD remained stable until postoperative year 5 and subsequently progressed according to the natural history of glaucomatous disease.ConclusionsImplantation of two iStents with concomitant cataract surgery is an effective and safe treatment option for surgery-naïve POAG eyes, evidenced by significant IOP and medication reductions, reasonable surgical success, and favorable safety outcomes, throughout the 8-year follow-up. Our data additionally supports the efficacy of this combined procedure in stabilizing or slowing disease progression.

Project description:BackgroundMinimally invasive glaucoma surgeries (MIGS) have attracted significant attention, as they have been reported to lower intra-ocular pressure (IOP) and have an excellent safety profile. The iStent is an example of a minimally invasive glaucoma device that has received particular attention due to its early and wide spread utilization. There is a growing body of evidence supporting its use at the time of phacoemulsification to help lower IOP. However, it is still not clear how much of the IOP lowering effect can be attributed to the iStent, the crystalline lens extraction or both when inserted concurrently at the time of phacoemulsification. This has been an important issue in understanding its potential role in the glaucoma management paradigm.PurposeTo conduct a systematic review and meta-analysis comparing the IOP lowering effect of iStent insertion at the time of phacoemulsification versus phacoemulsification alone for patients with glaucoma and cataracts.MethodsA systematic review was conducted utilizing various databases. Studies examining the IOP lowering effect of iStent insertion in combination with phacoemulsification, as well as studies examining the IOP lowering effect of phacoemulsification alone were included. Thirty-seven studies, reporting on 2495 patients, met the inclusion criteria. The percentage reduction in IOP (IOPR%) and mean reduction in topical glaucoma medications after surgery were determined. The standardized mean difference (SMD) was computed as a measure of the treatment effect for continuous outcomes taking into account heterogeneity. Fixed-effect and random-effect models were applied.ResultsA 4% IOP reduction (IOPR%) from baseline occurred following phacoemulsification as a solo procedure compared to 9% following an iStent implant with phacoemulsification, and 27% following 2 iStents implants with phacoemulsification. Compared with cataract extraction alone, iStent with phacoemulsification resulted in significant reduction in the post-operative IOP (IOPR%) (SMD = -0.46, 95% CI: [-0.87, -0.06]). A weighted mean reduction in the number of glaucoma medications per patient was 1.01 following phacoemulsification alone compared to 1.33 after one iStent implant with phacoemulsification, and 1.1 after 2 iStent implants with phacoemulsification. Compared to cataract extraction alone, iStent with cataract extraction showed a significant decrease in the number of glaucoma medications (SMD = -0.65, 95% CI: [-1.18, -0.12]). Funnel plots suggested the absence of publication bias.ConclusionBoth iStent implantation with concurrent phacoemulsification and phacoemulsification alone result in a significant decrease in IOP and topical glaucoma medications. In terms of both reductions, iStent with phacoemulsification significantly outperforms phacoemulsification alone.

Project description:BackgroundVarious surgical techniques have been described, to be combined with cataract surgery in glaucoma patients, aiming for an additional reduction of intraocular pressure (IOP), hence minimizing the burden of anti-glaucoma medication (AGM). Ultrasound ciliary plasty (UCP) is a recent microinvasive glaucoma surgery (MIGS) recommended for primary and refractory glaucoma. This study was conducted to evaluate the safety and efficacy of a new technique; combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP) as a primary surgical treatment for coexisting cataract and open angle glaucoma.MethodsA randomized clinical trial, including 61 eyes of 61 patients with visually significant cataract and open angle glaucoma, randomized to either Phaco-UCP (study group; 31 eyes) or phacoemulsification alone (Phaco-alone) (control group; 30 eyes). Primary outcomes included reduction in IOP and/or the number of AGM. Secondary outcomes included visual acuity improvement and complications. Qualified Success was defined as an IOP reduction ? 20% from baseline value, with an IOP 6-21?mmHg, with no additional AGM or glaucoma surgery. Failure was defined as either <?20% IOP reduction, despite AGM use, the need of glaucoma surgeries or serious complications.ResultsAt 18?months postoperatively, Phaco-UCP group had a median IOP reduction of 7?mmHg (Q1, Q3 = 3, 10) compared to 2?mmHg (Q1, Q3 = 2, 3) in Phaco-alone group (P <?0.001). Phaco-UCP group had significantly higher success rate at all time points reaching 67.7% at the last follow-up versus 16.7% only in Phaco-alone group (P<?0.001). The median number of AGM significantly decreased from [3 (Q1, Q3 = 2, 4), 3 (Q1, Q3 = 2,3)] respectively, (P =0.3)] at baseline to [1 (Q1,Q3 = 1, 2), 2 (Q1,Q3 = 2, 2)] respectively, (P <?0.001)] at 18?months postoperatively. No serious intraoperative or postoperative complications were encountered in either group.ConclusionPhaco-UCP is a simple, safe and effective procedure for management of coexisting cataract and open angle glaucoma.Trial registrationClinicalTrials.gov identifier, NCT04430647 ; retrospectively registered. June 12, 2020.

Project description:IntroductionMicro-invasive glaucoma surgical implantation of trabecular micro-bypass stents, previously shown to be safe and effective for open-angle glaucoma (OAG) subjects during cataract surgery, was considered for evaluation as a sole procedure. The aim of this study was to evaluate the safety and intraocular pressure (IOP)-lowering efficacy after ab interno implantation of two Glaukos Trabecular Micro-Bypass iStent inject second generation devices in subjects with OAG. This study was performed at sites in France, Germany, Italy, Republic of Armenia, and Spain.MethodsIn this pan-European, multi-center prospective, post-market, unmasked study, 99 patients with OAG on at least two topical ocular hypotensive medications who required additional IOP lowering to control glaucoma disease underwent implantation of two GTS400 stents in a stand-alone procedure. Patients were qualified if they presented with preoperative mean IOP between 22 and 38 mmHg after medication washout. Postoperatively, subjects were assessed at Day 1, Months 1, 3, 6, 7, 9, and 12. IOP, medication use and safety were assessed at each visit.ResultsSixty-six percent of subjects achieved IOP ≤18 mmHg at 12 months without medication, and 81% of subjects achieved Month 12 IOP ≤ 18 mmHg with either a single medication or no medication. Mean baseline washout IOP values decreased by 10.2 mmHg or 39.7% from 26.3 (SD 3.5) mmHg to 15.7 (SD 3.7) mmHg at Month 12. Mean IOP at 12 months was 14.7 (SD 3.1) mmHg in subjects not using ocular hypotensive medications. Reduction from preoperative medication burden was achieved in 86.9% of patients, including 15.2% with reduction of one medication and 71.7% with reduction of two or more medications. Postoperative complications occurred at a low rate and resolved without persistent effects.ConclusionIn this series, implantation of two trabecular micro-bypass second generation stents in subjects with OAG resulted in IOP and medication reduction and favorable safety outcomes.

Dataset Information

Treatment of Open-Angle Glaucoma with iStent Implantation Combined with Phacoemulsification in Polish Caucasian Population.

Purpose

Patients and methods

Results

Conclusion

Publications

Treatment of Open-Angle Glaucoma with iStent Implantation Combined with Phacoemulsification in Polish Caucasian Population.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets