Clinical Data

Clinical Data

Micro Stents. Macro Efficacy.

iStent inject® W builds on the trabecular micro-bypass technology of iStent inject®, which has demonstrated efficacy across a wide range of clinical studies.

US Pivotal Trial at 24 Months1

Primary Endpoint

≥ 20% Reduction in Unmedicated DIOP

Primary endpoint shows ≥ 20% Reduction in Unmedicated DIOP. Key: lighter blue is iStent inject + Phaco (N=380) and blue is Phaco along (N=118)

Secondary Endpoint

Mean Unmedicated DIOP Reduction

Secondary endpoint shows Mean Unmedicated DIOP Reduction. Key: lighter blue is iStent inject + Phaco (N=380) and blue is Phaco along (N=118)
Key: lighter blue is iStent inject + Phaco (N=380) and blue is Phaco along (N=118)

In the US IDE Trial (n=505 subjects), iStent inject® met all study endpoints and demonstrated a clinically significant reduction in IOP for iStent inject® subjects at 24 months.

  • 75.8% of iStent inject® subjects had ≥ 20% reduction in unmedicated DIOP
  • 7.0 mm Hg reduction from baseline in unmedicated DIOP

Other Observed Data:

  • 17.1 mm Hg mean medication-free IOP at 24 months
  • 63.2% medication-free DIOP ≤ 18 mm Hg at 24 months
  • Mean of 0.4 medications at 23 months, down from preoperative mean of 1.6 for the treatment arm

Independent Clinical Study Results

Additional independent, long-term studies of Glaukos trabecular micro-bypass technology suggest that results are maintained several years after the procedure.

Study (duration) # of Subjects (at endpoint) Post-Op Mean IOP (mmHG) % IOP Reduction % Medication Reduction
Study (duration) Guedes2 (12M) # of Subjects (at endpoint) 23 Post-Op Mean IOP (mmHG) 13.1 % IOP Reduction 19.1% % Medication Reduction 94.1%
Study (duration) Clement3 (12M) # of Subjects (at endpoint) 165 Post-Op Mean IOP (mmHG) 14.0 % IOP Reduction 23.2% % Medication Reduction 71.5%
Study (duration) Manning4 (12M) # of Subjects (at endpoint) 70 Post-Op Mean IOP (mmHG) 14.4 % IOP Reduction 29.4% % Medication Reduction 94.7%
Study (duration) Hengerer5 (84M) # of Subjects (at endpoint) 125 Post-Op Mean IOP (mmHG) 14.1 % IOP Reduction 40.0% % Medication Reduction 59.0%
Study (duration) Arriola-Villalobos6 (48M) # of Subjects (at endpoint) 20 Post-Op Mean IOP (mmHG) 16.25 % IOP Reduction 36.92% % Medication Reduction 42.3%

Long-Term IOP Reduction5

Chart showing intraocular pressure over time: preop at 22.3 decreasing to 14.8 at year three.

In a consecutive case series with three-year follow-up, mean IOP was 14.3 ± 1.7 mm Hg, representing a 37% reduction from preoperative medicated mean IOP of 22.6 ± 6.2 mm Hg; and 100% of eyes had IOP ≤ 18 mm Hg.

Sustained Medication Reduction5

A bar graph showing sustained medication reduction: mean medication use was decreased from 2.5 to 0.8 medications at three years, a 68% reduction. Reduction key: dark green is 0 Med, green is 1 Med, dark blue is 2 Med, bright blue is 3 Med, blue is 4+ Med.

In the same consecutive case series, mean medication use was decreased from 2.5 to 0.8 medications at three years, a 68% reduction; and 74% of eyes were using 0 or 1 medication compared to 21% preoperatively.

Safety

In the US IDE pivotal study, iStent inject® had no reports of hypotony, significant hyphema, flat anterior chamber, choroidal hemorrhage or effusion, or myopic shift.1,6

Medication reduction is subject to the discretion of the physician.

 

  1. Samuelson TW, Sarkisian SR, Lubeck DM, et al. Prospective, randomized, controlled pivotal trial of an ab interno implanted trabecular micro-bypass in primary open-angle glaucoma and cataract. Ophthalmology. Jun 2019;126(6):811-821.
  2. Guedes RAP, Gravina DM, Lake JC, Guedes VMP, Chaoubah A. Intermediate results of iStent® or iStent inject® implantation combined with cataract surgery in a real-world setting: a longitudinal retrospective study. Ophthalmol Ther. March 2019;8(1):87-100.
  3. Clement CI, Howes F, Ioannidis AS, Shiu M, Manning D. One-year outcomes following implantation of second-generation trabecular micro-bypass stents in conjunction with cataract surgery for various types of glaucoma or ocular hypertension: multicenter, multi-surgeon study. Clin Ophthalmol. 2019:13;491-499.
  4. Manning D. Real-world case series of iStent® or iStent inject® trabecular micro-bypass stents combined with cataract surgery. Ophthalmology & Therapy. 2019. doi:https://doi.org/10.1007/s40123-019-00208-x.
  5. Hengerer FH, Auffarth G, Conrad-Hengerer I. Sustained 7-year glaucoma control after second-generation trabecular micro-bypass with or without cataract surgery. Abstract presented at: Annual Meeting of the American Society of Cataract and Refractive Surgery; May 5-8, 2023; San Diego, CA.
  6. Arriola-Villalobos P, Martinez-de-la-Casa JM, Diaz-Valle D, et al. Glaukos iStent inject® trabecular micro-bypass implantation associated with cataract surgery in patients with coexisting cataract and open-angle glaucoma or ocular hypertension: a long-term study. J Ophthalmology. 2016;1-7.

 

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Five posters presented at ARVO 2021 highlight the efficacy and safety of the iStent platform as compared to other procedures.

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iStent inject® W Important Safety Information

Indication for Use

The iStent inject® W Trabecular Micro-Bypass System Model G2-W is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma.

Contraindications

The iStent inject® W is contraindicated in eyes with angle-closure glaucoma, traumatic, malignant, uveitic, or neovascular glaucoma, discernible congenital anomalies of the anterior chamber (AC) angle, retrobulbar tumor, thyroid eye disease, or Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.

Warnings

Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualization of the angle that could lead to improper placement of the stent and pose a hazard.

MRI Information

The iStent inject® W is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details.

Precautions

The surgeon should monitor the patient postoperatively for proper maintenance of IOP. The safety and effectiveness of the iStent inject® W have not been established as an alternative to the primary treatment of glaucoma with medications, in children, in eyes with significant prior trauma, abnormal anterior segment, chronic inflammation, prior glaucoma surgery (except SLT performed > 90 days preoperative), glaucoma associated with vascular disorders, pseudoexfoliative, pigmentary or other secondary open-angle glaucomas, pseudophakic eyes, phakic eyes without concomitant cataract surgery or with complicated cataract surgery, eyes with medicated IOP > 24 mmHg or unmedicated IOP < 21 mmHg or > 36 mmHg, or for implantation of more or less than two stents.

Adverse Events

Common postoperative adverse events reported in the iStent inject® randomized pivotal trial included stent obstruction (6.2%), intraocular inflammation (5.7% for iStent inject® vs. 4.2% for cataract surgery only), secondary surgical intervention (5.4% vs. 5.0%) and BCVA loss ≥ 2 lines ≥ 3 months (2.6% vs. 4.2%).

Caution

Federal law restricts this device to sale by, or on the order of, a physician. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.

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