title: Micro-Bypass Implantation for Primary Open-Angle Glaucoma Combined with Phacoemulsification: 4-Year Follow-Up.
abstract: Purpose. To report the long-term follow-up results in patients with cataract and primary open-angle glaucoma (POAG) randomly assigned to cataract surgery combined with micro-bypass stent implantation or phacoemulsification alone. Methods. 36 subjects with cataract and POAG were randomized in a 1 : 2 ratio to either iStent implantation and cataract surgery (combined group) or cataract surgery alone (control group). 24 subjects agreed to be evaluated again 48 months after surgery. Patients returned one month later for unmedicated washout assessment. Results. At the long-term follow-up visit we reported a mean IOP of 15,9 ± 2,3 mmHg in the iStent group and 17 ± 2,5 mmHg in the control group (p = NS). After washout, a 14,2% between group difference in favour of the combined group was statistically significant (p = 0,02) for mean IOP reduction. A significant reduction in the mean number of medications was observed in both groups compared to baseline values (p = 0,005 in the combined group and p = 0,01 in the control group). Conclusion. Patients in the combined group maintained low IOP levels after long-term follow-up. Cataract surgery alone showed a loss of efficacy in controlling IOP over time. Both treatments reduced the number of ocular hypotensive medications prescribed. This trial is registered with: NCT00847158.
authors.affiliation: Ophthalmic Clinic, Department of Surgical Sciences, University of Turin, 10122 Turin, Italy.
authors.forename: Antonio Maria
authors.initials: AM
authors.lastname: Fea
authors.affiliation: Ophthalmic Clinic, Department of Surgical Sciences, University of Turin, 10122 Turin, Italy.
authors.forename: Giulia
authors.initials: G
authors.lastname: Consolandi
authors.affiliation: Ophthalmic Clinic, Department of Surgical Sciences, University of Turin, 10122 Turin, Italy.
authors.forename: Marta
authors.initials: M
authors.lastname: Zola
authors.affiliation: Ophthalmic Clinic, Department of Surgical Sciences, University of Turin, 10122 Turin, Italy.
authors.forename: Giulia
authors.initials: G
authors.lastname: Pignata
authors.affiliation: Ophthalmic Clinic, Department of Surgical Sciences, University of Turin, 10122 Turin, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Cannizzo
authors.affiliation: Ophthalmic Clinic, Department of Surgical Sciences, University of Turin, 10122 Turin, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Lavia
authors.affiliation: Ophthalmic Clinic, Department of Surgical Sciences, University of Turin, 10122 Turin, Italy.
authors.forename: Teresa
authors.initials: T
authors.lastname: Rolle
authors.affiliation: Ophthalmic Clinic, Department of Surgical Sciences, University of Turin, 10122 Turin, Italy.
authors.forename: Federico Maria
authors.initials: FM
authors.lastname: Grignolo