Evaluation of the New Glaukos iStent
Evaluation of the New Glaukos iStent
Aims To evaluate the mid-term efficacy and safety of the GTS-400-iStent combined with phacoemulsification in patients with cataract and open-angle glaucoma (OAG) or ocular hypertension (OHT).
Methods Prospective, non-comparative, uncontrolled, interventional case series study. Subjects underwent phacoemulsification and two GTS-400 implantation. Efficacy outcomes: intraocular pressure (IOP) and antiglaucoma medications. Safety outcomes: complications, best-corrected visual acuity and endothelial cell count (ECC). Follow-up was 1 year.
Results 20 patients were enrolled (mean age: 75.1±8.6 years). Mean medicated baseline IOP was 19.95±3.71 mm Hg and 26±3.11 mm Hg without medication. Mean final IOP was 16.75±2.24, determining a final IOP decrease of 35.68% (9.42±3 mm Hg; p<0.001), from baseline washout IOP. Mean number of medications fell from 1.3±0.66 to 0.3±0.57 (P<0.001). 75% of patients were off medications at one year. Mean ECC decreased from 2289.64±393.5 cells/mm to 1986.95±520.58 cells/mm.
Conclusions Combined cataract surgery with implantation of GTS-400-iStent seems to be an effective and safe procedure.
Glaucoma affects over 60 million people worldwide and is the second leading cause of irreversible blindness. The disease is defined by morphological changes affecting the optic nerve and retinal nerve fibre layer along with visual field defects. Elevated intraocular pressure (IOP) is the most important risk factor for the development and progression of the disease. The only uncontroversial treatment modality that reduces the risk of disease progression is IOP reduction. The main objective of glaucoma management is to preserve visual function by achieving a stable, continuous IOP decrease through treatments with a good safety profile and no repercussions on quality of life. However, today no therapeutic option has all these characteristics. Pharmacological treatments have drawbacks such as difficult patient compliance, a poor response in some patients, drop instillation difficulties, local and systemic adverse events, and so on. Besides, in some cases, their pressure-lowering effects decrease over time and chronic use of antiglaucoma medications may lead to ocular surface damage and conjunctival inflammation. Laser trabeculoplasty is considered safe, but is usually accompanied by some inflammation, and the IOP decrease of 20–30% produced, is of limited duration. Incisional surgery is the most effective way of reducing IOP. However, surgery is usually done when topical antiglaucoma drugs and laser treatments fail to sufficiently reduce IOP to control the disease. Filtration surgery with or without the adjunctive use of antimetabolites has been linked to complications such as vision loss, bleb leak, inflammation, hypotony and endophthalmitis.
Cataract surgery often causes a mild reduction in IOP, and is considered a good management option in patients with cataract and medically well-controlled mild glaucoma.
In open-angle glaucoma, the major source of resistance to outflow is the trabecular meshwork. The iStent GTS-100 (Glaukos Corporation, Laguna Hills, California, USA) is a titanium L-shaped trabecular micro-bypass stent that has been successfully employed to increase outflow in human anterior segments in vitro and in glaucoma patients undergoing cataract surgery. Some studies have shown that phacoemulsification plus iStent GTS-100 implantation are significantly more effective in reducing IOP and medication use than phacoemulsification alone, even in the long term. A second generation iStent (GTS-400) has recently been developed. To the best of our knowledge, the efficacy and safety of the new Glaukos GTS-400 have not yet been the subject of any research article.
This study was designed to assess the mid-term efficacy and safety of iStent GTS-400 combined with phacoemulsification in patients with coexistent cataract and open-angle glaucoma or ocular hypertension (OHT).
Abstract and Introduction
Abstract
Aims To evaluate the mid-term efficacy and safety of the GTS-400-iStent combined with phacoemulsification in patients with cataract and open-angle glaucoma (OAG) or ocular hypertension (OHT).
Methods Prospective, non-comparative, uncontrolled, interventional case series study. Subjects underwent phacoemulsification and two GTS-400 implantation. Efficacy outcomes: intraocular pressure (IOP) and antiglaucoma medications. Safety outcomes: complications, best-corrected visual acuity and endothelial cell count (ECC). Follow-up was 1 year.
Results 20 patients were enrolled (mean age: 75.1±8.6 years). Mean medicated baseline IOP was 19.95±3.71 mm Hg and 26±3.11 mm Hg without medication. Mean final IOP was 16.75±2.24, determining a final IOP decrease of 35.68% (9.42±3 mm Hg; p<0.001), from baseline washout IOP. Mean number of medications fell from 1.3±0.66 to 0.3±0.57 (P<0.001). 75% of patients were off medications at one year. Mean ECC decreased from 2289.64±393.5 cells/mm to 1986.95±520.58 cells/mm.
Conclusions Combined cataract surgery with implantation of GTS-400-iStent seems to be an effective and safe procedure.
Introduction
Glaucoma affects over 60 million people worldwide and is the second leading cause of irreversible blindness. The disease is defined by morphological changes affecting the optic nerve and retinal nerve fibre layer along with visual field defects. Elevated intraocular pressure (IOP) is the most important risk factor for the development and progression of the disease. The only uncontroversial treatment modality that reduces the risk of disease progression is IOP reduction. The main objective of glaucoma management is to preserve visual function by achieving a stable, continuous IOP decrease through treatments with a good safety profile and no repercussions on quality of life. However, today no therapeutic option has all these characteristics. Pharmacological treatments have drawbacks such as difficult patient compliance, a poor response in some patients, drop instillation difficulties, local and systemic adverse events, and so on. Besides, in some cases, their pressure-lowering effects decrease over time and chronic use of antiglaucoma medications may lead to ocular surface damage and conjunctival inflammation. Laser trabeculoplasty is considered safe, but is usually accompanied by some inflammation, and the IOP decrease of 20–30% produced, is of limited duration. Incisional surgery is the most effective way of reducing IOP. However, surgery is usually done when topical antiglaucoma drugs and laser treatments fail to sufficiently reduce IOP to control the disease. Filtration surgery with or without the adjunctive use of antimetabolites has been linked to complications such as vision loss, bleb leak, inflammation, hypotony and endophthalmitis.
Cataract surgery often causes a mild reduction in IOP, and is considered a good management option in patients with cataract and medically well-controlled mild glaucoma.
In open-angle glaucoma, the major source of resistance to outflow is the trabecular meshwork. The iStent GTS-100 (Glaukos Corporation, Laguna Hills, California, USA) is a titanium L-shaped trabecular micro-bypass stent that has been successfully employed to increase outflow in human anterior segments in vitro and in glaucoma patients undergoing cataract surgery. Some studies have shown that phacoemulsification plus iStent GTS-100 implantation are significantly more effective in reducing IOP and medication use than phacoemulsification alone, even in the long term. A second generation iStent (GTS-400) has recently been developed. To the best of our knowledge, the efficacy and safety of the new Glaukos GTS-400 have not yet been the subject of any research article.
This study was designed to assess the mid-term efficacy and safety of iStent GTS-400 combined with phacoemulsification in patients with coexistent cataract and open-angle glaucoma or ocular hypertension (OHT).
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