Dataset Information

Ocular Antihypertensive Medication Use After iStent Implantation Concurrent With Cataract Surgery vs Cataract Surgery Alone in a Large US Health Care Claims Database.

ABSTRACT:

Importance

The iStent Trabecular Micro-Bypass (Glaukos Corporation) is a minimally invasive glaucoma implant used in conjunction with cataract surgery to lower intraocular pressure.

Objective

To determine whether implantation of the iStent concurrent with cataract surgery is associated with reduced use of ocular antihypertensive medications in a US health care claims database.

Design, setting, and participants

Retrospective, observational longitudinal cohort study of individuals enrolled in a US managed care network who underwent iStent implantation with cataract surgery (iStent/CEIOL) from 2012 to 2016 (n?=?1509 bilateral and n?=?1462 unilateral surgery). A control group of individuals who underwent bilateral cataract surgery only (CEIOL) were matched 1:1 to patients undergoing bilateral iStent/CEIOL on baseline demographic and clinical factors. Data were analyzed between November 1, 2017, and January 31, 2018.

Main outcomes and measures

The number of topical ocular antihypertensive agents used postoperatively by patients undergoing iStent/CEIOL compared with baseline and with matched CEIOL control individuals, and hazard ratios with 95% confidence intervals for sustained reduced use of at least 1 topical ocular antihypertensive agent postoperatively.

Results

Of the 2971 eligible enrollees, mean age at first surgery was 74.3 years, and 1659 (55.8%) were women. Patients undergoing iStent/CEIOL had diagnoses that included primary open-angle glaucoma (n?=?2329; 78.4%), narrow angles (n?=?381; 12.8%), and secondary glaucomas (n?=?261; 8.8%). At baseline, 1223 (41.2%) were receiving no topical glaucoma agents; 876 (29.5%), 437 (14.7%), and 435 (14.6%) were receiving 1, 2, or at least 3 agents, respectively. Although only 678 persons (22.8%) completed at least 2 years of postoperative follow-up, the proportion of patients receiving no drops increased postoperatively (64.7%, 20-24 months, P?Conclusions and relevanceImplantation of the iStent trabecular micro-bypass stent concurrent with cataract surgery was associated with moderately reduced use of topical ocular antihypertensive medication. Reduction in the use of glaucoma medications may lessen the burden of medication adverse effects and promote better adherence.

SUBMITTER: Wang SY

PROVIDER: S-EPMC6439782 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Publications

Ocular Antihypertensive Medication Use After iStent Implantation Concurrent With Cataract Surgery vs Cataract Surgery Alone in a Large US Health Care Claims Database.

Wang Sophia Y SY Singh Kuldev K Stein Joshua D JD Chang Robert T RT

JAMA ophthalmology 20190101 1

<h4>Importance</h4>The iStent Trabecular Micro-Bypass (Glaukos Corporation) is a minimally invasive glaucoma implant used in conjunction with cataract surgery to lower intraocular pressure.<h4>Objective</h4>To determine whether implantation of the iStent concurrent with cataract surgery is associated with reduced use of ocular antihypertensive medications in a US health care claims database.<h4>Design, setting, and participants</h4>Retrospective, observational longitudinal cohort study of indivi ...[more]

PMID: 30267072

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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:Introduction: This study sought to assess ocular surface disease changes following cataract surgery combined with trabecular micro-bypass stent(s) implantation (iStent or iStent inject).Methods: This prospective interventional single-arm clinical trial enrolled 47 eyes with mild-to-moderate open-angle glaucoma (OAG) on 1-4 glaucoma medications who underwent phacoemulsification and trabecular micro-bypass stent(s) implantation. Key glaucoma and ocular surface data through 3 months postoperatively included the Ocular Surface Disease Index score (OSDI), corneal/conjunctival staining (Oxford Schema), fluorescein tear break-up time (FTBUT), conjunctival hyperemia (Efron Scale), glaucoma medications, and intraocular pressure (IOP).Results: Mean OSDI scores improved from 40.1?±?21.6 (severe) preoperatively to 17.5?±?15.3 (mild) at 3 months (p?<?0.0001). While 73% of eyes had moderate or severe OSDI scores preoperatively, 29% had such scores at 3 months, and the OSDI score was normal in 57% of eyes versus 9% preoperatively. Mean FTBUT increased from 4.3?±?2.4 s preoperatively to 6.4?±?2.5 s at 3 months (p?<?0.0001); mean Oxford corneal/conjunctival staining reduced from 1.4?±?1.0 preoperatively to 0.4?±?0.6 at 3 months (p?<?0.0001); mean Efron conjunctival hyperemia score reduced from 1.4?±?0.7 preoperatively to 1.2?±?0.6 at 3 months (p?=?0.118). The number of glaucoma medications decreased from 1.5?±?0.9 to 0.6?±?0.8 mean medications (60% reduction, p?<?0.0001), with all eyes maintaining or reducing medications versus preoperatively and 55% of eyes becoming medication-free (versus 0% preoperatively). Mean IOP reduced from 17.4?±?4.2 mmHg to 14.5?±?3.2 mmHg (p?<?0.0001). The safety profile was excellent.Conclusion: Implantation of trabecular micro-bypass stent(s) (iStent or iStent inject) with cataract surgery produced significant improvements in ocular surface health, alongside significant reductions in IOP and medications.Trial registration: ClinicalTrials.gov identifier, NCT04452279.

Project description:PURPOSE:To compare the efficacy and safety of combined cataract extraction and either excisional goniotomy performed with the Kahook Dual Blade (KDB; phaco-KDB group) or single iStent trabecular bypass implantation (phaco-iStent group) in eyes with mild to moderate glaucoma and visually significant cataract. METHODS:This was a retrospective analysis of 315 eyes from 230 adults with mild or moderate glaucoma treated with one or more intraocular pressure (IOP)-lowering medications (190 eyes of 134 subjects in the phaco-KDB group and 125 eyes of 96 subjects in the phaco-iStent group) that required no subsequent surgical intervention for IOP control through 12 months of follow-up. Data included best-corrected visual acuity (BCVA), IOP, and IOP-lowering medications, collected preoperatively and at 1 week and 1, 3, 6, and 12 months postoperatively as well as intraoperative and postoperative adverse events. The primary efficacy outcomes were the proportion of subjects in each group achieving ≥ 20% IOP reduction and ≥ 1 medication reduction at month 12. Subgroup analysis by baseline IOP (≤ 18 mmHg vs. > 18 mmHg) was also performed. RESULTS:Mean (standard error) baseline IOP was 18.2 (0.3) mmHg in the phaco-KDB group and 16.7 (0.3) mmHg in the phaco-iStent group (p = 0.001). Statistically significant mean IOP and mean IOP medication reductions from baseline were achieved at all time points in both groups. Mean IOP reductions were significantly greater in the phaco-KDB group than in the phaco-iStent group at all time points including month 12 [- 5.0 (0.3) mmHg vs. - 2.3 (0.4) mmHg, p < 0.001], while mean medication reductions were similar between groups at all time points except week 1, when greater mean medication reduction was seen in the phaco-iStent group (- 1.23 vs. - 0.60 medications, p < 0.001). At month 12, IOP reductions ≥ 20% were achieved by 64.2% and 41.6% (p < 0.001) in the phaco-KDB and phaco-iStent groups, respectively, and IOP medication reductions of ≥ 1 medication were achieved by 80.4% and 77.4% (p = 0.522), respectively. Intraocular pressure subgroup analysis revealed significant reductions in IOP-lowering medications without compromise of IOP control in lower IOP subgroups and significant reductions in both IOP and IOP-lowering medications in the higher IOP subgroups. The most common adverse events were transient IOP elevations and transient anterior chamber inflammation, which occurred with similar frequency in both groups and resolved spontaneously. CONCLUSION:Goniotomy with the KDB lowered IOP significantly more than iStent implantation, with few adverse events in both groups. In eyes with mild to moderate glaucoma undergoing combined cataract extraction and glaucoma surgery, goniotomy with the KDB can safely deliver statistically significant and clinically meaningful reductions in both IOP and IOP medication burden through 12 months of follow-up. FUNDING:New World Medical, Inc., provided funding for the study, medical writing assistance, Rapid Service Fees, and the open access fee.

Project description:ObjectiveWe aim to systematically assess and compare corneal endothelial cell density (ECD) loss in patients with glaucoma following glaucoma surgery and cataract surgery.IntroductionCorneal ECD loss may occur due to intraoperative surgical trauma in glaucoma surgery or postoperatively with chronic endothelial cell trauma or irritation. Corneal oedema and decompensation after aqueous shunt glaucoma surgery has been reported but the long-term ECD loss is still unknown.Inclusion criteriaTrabeculectomy, glaucoma filtration surgery or microinvasive glaucoma surgery in adults with ocular hypertension, primary and secondary open angle glaucoma, normal tension glaucoma and angle-closure glaucoma. Participants with pre-existing corneal disease will be excluded. Glaucoma laser treatments and peripheral iridotomy will be excluded. The outcomes include preoperative and postoperative corneal ECD, percentage change of corneal ECD and adverse events.MethodsWe will conduct an electronic database search for randomised controlled trials, prospective non-randomised studies, observational studies in MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), ClinicalTrials.gov and The International Prospective Register of Systematic Reviews (PROSPERO). Eligibility criteria will include quantitative articles published after and including the year 2000, written in English and containing data on ECD loss. Two independent reviewers will screen titles and abstracts and extract data from full texts, reporting outcomes according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data extraction of key characteristics will be completed using customised forms. Methodological quality will be assessed using the Joanna Briggs Institute critical appraisal forms.Ethics and disseminationEthics approval is not required for this review, as it will only include published data. Findings will be published in a peer-reviewed journal and disseminated across ophthalmic networks.Prospero registration numberPROSPERO CRD42020192303.

Dataset Information

Ocular Antihypertensive Medication Use After iStent Implantation Concurrent With Cataract Surgery vs Cataract Surgery Alone in a Large US Health Care Claims Database.

Importance

Objective

Design, setting, and participants

Main outcomes and measures

Results

Publications

Ocular Antihypertensive Medication Use After iStent Implantation Concurrent With Cataract Surgery vs Cataract Surgery Alone in a Large US Health Care Claims Database.

Similar Datasets

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