
Affecting an estimated 76 million people worldwide in 2020 (1), glaucoma is the leading cause of irreversible vision loss and the second leading cause of blindness worldwide (2). Open angle glaucoma (OAG) is the most common form, occurring in 74 percent of diagnosed glaucoma cases (3, 4). It is often seen in conjunction with cataract, with approximately one-in-five cataract patients also needing glaucoma medication (5).
These numbers present both a daunting challenge and a major opportunity. Elevated intraocular pressure (IOP) remains the major risk factor for glaucoma and most current treatments, including pharmacological, laser and surgical intervention, focus on lowering IOP (6). Yet each have drawbacks.
Ever since Glaukos pioneered the micro-invasive glaucoma surgery (MIGS) category, iStent® devices have been the gold standard for ophthalmic professionals around the world. iStent inject® W is the latest Glaukos generation of categoryleading Trabecular Micro-Bypass (TMB) device backed by the same level of robust scientific evidence, clinical rigor, and data integrity that previous generations are known for.
Measuring 360 microns deep and wide, iStent inject® W is one of the smallest medical implants now available. In bypassing the trabecular meshwork, which is often the major obstruction to fluid drainage in openangle glaucoma (6), the stent is designed to restore physiological aqueous outflow directly to Schlemm’s canal (8).
The success of the iStent® technology has been reported in more than 200 published peer-reviewed studies, backed by more than 20 years of clinical data and more than 800,000 implantations to date.
More than 16 published studies with four to eight years of follow-up studies† have shown that in select patients with ocular hypertension (OHT) or mild to moderate primary open-angle glaucoma (POAG) the iStent® technologies reliably reduce IOP up to 40 percent or more while lessening the need for medications (6, 9, 14, 15, 16), and spare conjunctival tissue in the event more invasive surgery is later needed.
Whether combined with cataract surgery or implanted as standalone procedure, studies show the iStent inject® devices significantly reduce IOP as well as the mean number of topical medications needed to control IOP. In many cases, trabecular micro-bypass stenting eliminates the need for glaucoma medication entirely (3, 6, 9).
By intervening at the same time as cataract surgery, iStent inject® W may delay the need for more invasive or bleb-forming surgeries, reduce the number of follow-up appointments (10) and potentially reduce medication and health costs (11), making it easier for physicians to meet the current – and future – needs of their patient population, affordably.
For qualified patients, iStent inject® W may provide substantial clinical and lifestyle advantages, giving glaucoma and cataract surgeons a new tool to help prevent long-term vision loss while improving patient quality of life.
The reduction in medication commonly seen with iStent inject® implantation may translate into improved quality of life. In fact, a 24-month pivotal study comparing outcomes of iStent inject plus phaco to phaco alone by Thomas W Samuelson MD and colleagues found that the combined procedure may improve ocular symptoms and vision-related activities more than cataract surgery alone.
Involving 505 patients randomised three to one to combined or phaco alone surgery, the study found a higher percentage of responders reporting improvement in the combined group on the Visual Function Questionnaire (VFQ-25) and the Ocular Surface Disease Index (OSDI) at 1, 6, 12 and 24 months after surgery. Differences in response rates on the VFQ-25 were most pronounced in the General Vision, Ocular Pain and Driving subscales (13).
With treatments to address the full range of glaucoma disease states – from ocular hypertension to advanced glaucoma in the near future – Glaukos continues to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical glaucoma therapies.
References
- World report on vision. World Health Organization 2019.
- Steinmetz JD, Bourne RRA et al. Causes of blindness and vision impairment in 2020 and trends over 30 years, and prevalence of avoidable blindness in relation to VISION 2020: the Right to Sight: an analysis for the Global Burden of Disease Study. Lancet Glob Health 2021;9: e144-60.
- Healey PR, Clement CI, Kerr NM, Tilden D, Aghajanian L. Standalone iStent trabecular micro-bypass glaucoma surgery: a systematic review and meta-analysis. J Glaucoma Published Ahead of Print 2021.
- Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. British Journal of Ophthalmology. 2006;90(3):262-267.
- Shrivastava A et al. Analysis of US Medicare data. ASCRS presentation, 2017.
- Lindstrom R, Sarkisian SR, Lewis R, Hovanesian J, Voskanyan L. Four-Year Outcomes of Two Second-Generation Trabecular Micro-Bypass Stents in Patients with Open-Angle Glaucoma on One Medication. Clin Ophthalmol 2020;14:71-80.
- Baudouin C, Labbé A, Liang H, Pauly A, Brignole-Baudouin F. Preservatives in eyedrops: the good, the bad and the ugly. Prog Retin Eye Res. 2010;29(4):312–334.
- Samuelson TW et al. Randomized evaluation of the trabecular micro-bypass stent in patients with glaucoma and cataracts. Ophthalmology 2011;118:459-467.
- Hengerer F, Auffarth G, Conrad-Hengerer I. Five-year outcomes of trabecular micro-bypass stents (iStent inject) implanted with or without cataract surgery. ESCRS presentation, 2021.
- RAP Guedes et al., “Intermediate Results of iStent or iStent inject implantation combined with cataract surgery in a real-world setting: a longitudinal retrospective study”, Ophthalmol Ther, 8, 87 (2019). PMID: 30721523.
- K Ngan et al., “A cost minimisation analysis comparing iStent accompanying cataract surgery and selective laser trabeculoplasty versus topical glaucoma medications in a public healthcare setting in New Zealand”, Graefes Arch Clin Exp Ophthalmol, 256, 2181 (2018). PMID: 30132278.
- Schweitzer JA, Hauser WH, Ibach M, Baartman B, Gollamudi SR, Crothers AW, Linn JE, Berdahl JP. Prospective Interventional Cohort Study of Ocular Surface Disease Changes in Eyes After Trabecular Micro-Bypass Stent(s) Implantation (iStent or iStent inject) with Phacoemulsification. Ophthalmol Ther. Published online 13 Aug 2020.
- Samuelson TW, Singh IP, Williamson BK, Falvey H, Lee WC, Odom D, McSorley D, Katz LJ. Quality of Life in Primary Open-Angle Glaucoma and Cataract: An Analysis of VFQ-25 and OSDI From the iStent inject Pivotal Trial. Am J Ophthalmol 2021;229:220–229.
- Hengerer FH, Aufarth GU, Riffel C, Conrad-Hengerer I. Prospective, Non-randomized, 36-Month Study of Second-Generation Trabecular Micro-Bypass Stents with Phacoemulsification in Eyes with Various Types of Glaucoma. Ophtalm Ther 2018 Dec;7(2):405-415.
- Hengerer FH. Personal experience with second-generation trabecular microbypass stents in combination with cataract surgery in patients with glaucoma: 3-year follow-up. ASCRS 2018 Presentation.
- Hengerer FH, Aufarth GU, Riffel C, Conrad-Hengerer I. Second-Generation Trabecular Micro-Bypass Stents as Standalone Treatment for Glaucoma: A 36-Month Prospective Study. Advances in Therapy 2019;36:1606-1617.