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INTRODUCTION: To assess the effect of iStent trabecular micro-bypass implantation combined with phacoemulsification on intraocular pressure (IOP) and glaucoma medications, and to compare this to outcomes of phacoemulsification alone in patients with mild to moderate primary open-angle glaucoma (POAG) depending on initial IOP. MATERIAL AND METHODS: 80 subjects with cataract and POAG were randomized 1:1 to either iStent implantation and cataract surgery (iStent group) (n=44) or cataract surgery alone (control group) (n=36). Groups were divided according to initial IOP (after wash out period) into IOP < 26 mmHg, and IOP ≥26 mmHg. Patients were assessed preoperatively and at postoperative day 1, week 1, and months 1, 3, 6, 12 and 24. Outcome measures included best corrected visual acuity (BCVA), IOP and glaucoma medications. RESULTS: Post-operatively at 24 months, mean IOP decreased from 20.93 ± 1.28 mmHg to 17.79 ± 2.50 in the IOP subgroup <26 mmHg and from 26.00 ± 0.00 to 19.86 ± 2.19 in the subgroup ≥26 mmHg in control group. In the iStent group <26 mmHg IOP decreased from 22.04 ± 1.64 mmHg to 15.57±2.13 and from 26.6 ±1.09 mmHg to 17.06±2.43 in the iStent group ≥ 26 mmHg. CONCLUSION: In patients with open-angle glaucoma and cataract, iStent implantation combined with cataract surgery reduced IOP significantly through 2 years, with greater reductions achieved versus phacoemulsification alone. In patients with baseline IOP <26mmHg surgery reduced IOP and medication use significantly decline through 2 years, with greater reductions achieved versus patients with baseline IOP ≥26 mmHg. The study was registered at ClinicalTrials.gov under the number NCT03807869.
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12.14.3 Phacoemulsification (Part of: 12 Surgical treatment > 12.14 Combined cataract extraction and glaucoma surgery)
12.8.2 With tube implant or other drainage devices (Part of: 12 Surgical treatment > 12.8 Filtering surgery)
9.4.4.2 Glaucomas associated with cataracts (Part of: 9 Clinical forms of glaucomas > 9.4 Glaucomas associated with other ocular and systemic disorders > 9.4.4 Glaucomas associated with disorders of the lens)