Clinical evaluation of a trabecular microbypass stent with phacoemulsification in patients with open-angle glaucoma and cataract

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Abstract

Purpose

To evaluate the safety and efficacy of the iStent trabecular microbypass stent in combination with cataract surgery in patients with open-angle glaucoma (OAG).

Methods

Retrospective, consecutive case series from October 2012 to December 2015 with no exclusion criteria. The series comprised of 350 eyes with OAG and cataract. Data were collected both preoperatively and postoperatively at day 1 week 1, months 1, 3, 6, 12, 18, and 24. Data included intraocular pressure (IOP), number of glaucoma medications, visual acuity, the incidence of postoperative IOP pressure spikes of greater than ≥15 mmHg at any time point, and need for additional surgery.

Results

The mean preoperative IOP was 19.13±6.34 mmHg. At 2 years postoperation, mean IOP was 15.17±3.53 mmHg ( P<0.0001). The mean number of glaucoma medications was 1.19±1.00 preoperatively and 0.61±0.96 ( P<0.0001) at 2 years postoperation. At 1 day postoperatively, 31 eyes (12.4%) experienced an IOP increase of 15 mmHg above their baseline IOP that responded to topical therapy. Two patients required additional tube shunt surgery.

Conclusion

The insertion of the iStent trabecular microbypass stent in combination with cataract surgery effectively lowers IOP in OAG patients. The magnitude of IOP reduction was more significant in patients with higher preoperative pressure. Medication use was also significantly reduced postoperatively. The safety profile appears favorable with a low rate of IOP spikes and only two eyes (<1%) requiring additional surgery.

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Most cited references 14

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Micro-invasive glaucoma surgery: current perspectives and future directions.

Hady Saheb, Iqbal Ahmed (2012)

There is an increasing interest and availability of micro-invasive glaucoma surgery (MIGS) procedures. It is important that this increase is supported by sound, peer-reviewed evidence. This article will define MIGS, review relevant publications in the period of annual review and discuss future directions. The results of the pivotal trial comparing a trabecular micro-bypass stent (iStent, Glaukos Corporation, Laguna Hills, CA, USA) combined with phacoemulsification to phacoemulsification alone showed a significantly higher percentage of patients with unmedicated intraocular pressure (IOP) ≤ 21 mmHg, and a comparable safety profile. Initial results are published regarding a second-generation micro-bypass stent (iStent inject, Glaukos Corporation, Laguna Hills, CA, USA), a canalicular scaffold (Hydrus, Ivantis Inc., Irvine, CA, USA) and an ab interno suprachoroidal microstent (CyPass, Transcend Medical, Menlo Park, CA, USA), showing a decrease in mean postoperative IOP. Phaco-Trabectome (Ab interno trabeculectomy Trabectome, NeoMedix Inc., Tustin, CA, USA) was compared to phacotrabeculectomy and showed less IOP reduction, less postoperative complications, and a similar success rate. Similar success rates were found with the comparison of excimer laser trabeculostomy (ELT, AIDA, Glautec AG, Nurnberg, Germany) and selective laser trabeculoplasty. A number of publications review the importance of the location of implantable devices, intraoperative gonioscopy, cost-effectiveness and quality-of-life studies, and randomized clinical trials. MIGS procedures offer reduction in IOP, decrease in dependence on glaucoma medications and an excellent safety profile. Their role within our glaucoma treatment algorithm continues to be clarified and differs from the role of more invasive glaucoma surgeries such as trabeculectomy or glaucoma drainage devices.

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Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract.

Thomas W Samuelson, L. Jay Katz, Jeffrey M. Wells … (2011)

To assess the safety and efficacy of the iStent trabecular micro-bypass stent (Glaukos Corporation, Laguna Hills, CA) in combination with cataract surgery in subjects with mild to moderate open-angle glaucoma. Prospective, randomized, open-label, controlled, multicenter clinical trial. A total of 240 eyes with mild to moderate open-angle glaucoma with intraocular pressure (IOP) ≤24 mmHg controlled on 1 to 3 medications were randomized to undergo cataract surgery with iStent implantation (treatment group) or cataract surgery only (control). Fifty additional subjects were enrolled to undergo cataract surgery with iStent implantation under protocol expansion. Data in this report are based on the first 240 eyes enrolled. Implantation of the iStent trabecular micro-bypass stent in conjunction with cataract surgery or cataract surgery only. The primary efficacy measure was unmedicated IOP ≤21 mmHg at 1 year. A secondary measure was unmedicated IOP reduction ≥20% at 1 year. Safety measures included best-corrected visual acuity (BCVA), slit-lamp observations, complications, and adverse events. The study met the primary outcome, with 72% of treatment eyes versus 50% of control eyes achieving the criterion (P<0.001). At 1 year, IOP in both treatment groups was statistically significantly lower from baseline values. Sixty-six percent of treatment eyes versus 48% of control eyes achieved ≥20% IOP reduction without medication (P = 0.003). The overall incidence of adverse events was similar between groups with no unanticipated adverse device effects. Pressure reduction on fewer medications was clinically and statistically significantly better 1 year after stent plus cataract surgery versus cataract surgery alone, with an overall safety profile similar to that of cataract surgery alone. Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

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Cataract surgery with trabecular micro-bypass stent implantation in patients with mild-to-moderate open-angle glaucoma and cataract: two-year follow-up.

E. Craven, L. Jay Katz, Jeffrey M. Wells … (2012)

To assess the long-term safety and efficacy of a single trabecular micro-bypass stent with concomitant cataract surgery versus cataract surgery alone for mild to moderate open-angle glaucoma. Twenty-nine investigational sites, United States. Prospective randomized controlled multicenter clinical trial. Eyes with mild to moderate glaucoma with an unmedicated intraocular pressure (IOP) of 22 mm Hg or higher and 36 mm Hg or lower were randomly assigned to have cataract surgery with iStent trabecular micro-bypass stent implantation (stent group) or cataract surgery alone (control group). Patients were followed for 24 months postoperatively. The incidence of adverse events was low in both groups through 24 months of follow-up. At 24 months, the proportion of patients with an IOP of 21 mm Hg or lower without ocular hypotensive medications was significantly higher in the stent group than in the control group (P=.036). Overall, the mean IOP was stable between 12 months and 24 months (17.0 mm Hg ± 2.8 [SD] and 17.1 ± 2.9 mm Hg, respectively) in the stent group but increased (17.0 ± 3.1 mm Hg to 17.8 ± 3.3 mm Hg, respectively) in the control group. Ocular hypotensive medication was statistically significantly lower in the stent group at 12 months; it was also lower at 24 months, although the difference was no longer statistically significant. Patients with combined single trabecular micro-bypass stent and cataract surgery had significantly better IOP control on no medication through 24 months than patients having cataract surgery alone. Both groups had a similar favorable long-term safety profile. Dr. Craven was an investigator in the clinical trial of the iStent. Dr. Katz is a consultant to Glaukos and was the medical monitor for the clinical trial of the iStent. Dr. Katz is a stockholder in Glaukos. Mr. Wells and Ms. Giamporcaro are employees of Glaukos. Copyright © 2012 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

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Author and article information

Journal

Journal ID (nlm-ta): Clin Ophthalmol

Journal ID (iso-abbrev): Clin Ophthalmol

Journal ID (publisher-id): Clinical Ophthalmology

Title: Clinical Ophthalmology (Auckland, N.Z.)

Publisher: Dove Medical Press

ISSN (Print): 1177-5467

ISSN (Electronic): 1177-5483

Publication date Collection: 2016

Publication date (Electronic): 14 September 2016

Volume: 10

Pages: 1767-1773

Affiliations

[1 ]Sanford School of Medicine, University of South Dakota, Sanford School of Medicine, Sioux Falls, SD, USA

[2 ]Vance Thompson Vision, Sioux Falls, SD, USA

Author notes

Correspondence: Tanner J Ferguson, Vance Thompson Vision, 3101 W 57th St, Sioux Falls, SD 57108, USA, Tel +1 712 899 6153, Email tannerferguson@ 123456me.com

Article

Publisher ID: opth-10-1767

DOI: 10.2147/OPTH.S114306

PMC ID: 5028087

PubMed ID: 27695280

SO-VID: 8eb6b70c-6d7d-4c6b-b818-bb4808ffbdbd

License:

The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

Clinical evaluation of a trabecular microbypass stent with phacoemulsification in patients with open-angle glaucoma and cataract

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Clinical Virtual Research Center Journal of Ophthalmology

Most cited references 14

Micro-invasive glaucoma surgery: current perspectives and future directions.

Randomized evaluation of the trabecular micro-bypass stent with phacoemulsification in patients with glaucoma and cataract.

Cataract surgery with trabecular micro-bypass stent implantation in patients with mild-to-moderate open-angle glaucoma and cataract: two-year follow-up.

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