Clinical Data

iStent^® Clinical Data

Trabecular micro-bypass technology developed by Glaukos has been studied extensively around the world and its efficacy has been demonstrated in over 200 peer-reviewed articles, 20 years of clinical use, and over one million eyes.

The implantation of two trabecular bypass stents – without the benefit of cataract surgery – has been shown in prospective clinical trials as described below to both lower IOP to <15 mm Hg and reduce medication burden via a unique two stent approach:

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%

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%

Can Reduce Intraocular Pressure (IOP) and
Medication Burden

Numerous studies have demonstrated that iStent inject^® is effective in lowering IOP at the discretion of a physician.

In one consecutive case study involving multiple international surgeons, a mean IOP reduction of 34% vs. medicated screening (13.6 mmHg vs. 20.6 mmHg) was found at 12 months.⁶ Additionally, average medication usage was reduced from 1.0 to 0.1.⁶

Long-Term IOP Reduction⁵

Another study conducted by multiple international surgeons found postop medication-free mean IOP was 8.2 mmHg lower than preop unmedicated mean IOP, showing that use of stents alone resulted in a 32% IOP reduction.⁷

Sustained Medication Reduction⁵

Line chart showing the mean IOP over time with a mean IOP reduction of 34% as compared to the medicated screening.

In the 12-month postoperative visit of the Synergy Study, a multi-centre study conducted in Europe, subjects who remained off medication demonstrated a mean IOP reduction of 34% as compared to the medicated screening.⁸ The Synergy Study also showed that 72% of patients experienced IOP reduction ≥20% without medication at 12 months postoperative.⁸

At 12 month post-operative visit⁸:

Medication reduction is subject to the discretion of the physician.

References

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.
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.
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.
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.
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.
Chang, DF. Intraocular Pressure Reduction and Safety Outcomes After Micro-Invasive Glaucoma Surgery with 2 Trabecular Bypass Stents in OAG. Presented at the 2013 American Society of Cataract and Refractive Surgery Annual Meeting; April 19-23, 2013; San Francisco, California, USA.
Ahmed II, Katz LJ, Chang DF, Donnenfeld ED, Solomon KD, Voskanyan L, Samuelson TW. Prospective evaluation of microinvasive glaucoma surgery with trabecular microbypass stents and prostaglandin in open-angle glaucoma. J Cataract Refract Surg 2014 Aug;40:1295–1300.
Voskanyan L, García-Feijoó J, Belda J, Fea A, Jünemann A, Baudouin C. “Prospective, Unmasked Evaluation of the iStent inject System for Open-Angle Glaucoma: Synergy Trial”. Adv Ther 2014; 31:189-201.

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iStent^® Clinical Data

Independent Clinical Study Results