Dataset Information

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.

SUBMITTER: Fea AM

PROVIDER: S-EPMC4637500 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Micro-Bypass Implantation for Primary Open-Angle Glaucoma Combined with Phacoemulsification: 4-Year Follow-Up.

Fea Antonio Maria AM Consolandi Giulia G Zola Marta M Pignata Giulia G Cannizzo Paola P Lavia Carlo C Rolle Teresa T Grignolo Federico Maria FM

Journal of ophthalmology 20151026

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 returne ...[more]

PMID: 26587282

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Project description:ImportanceAdditional data are sought regarding treatment options for glaucoma, a major cause of global blindness.BackgroundThe study assessed outcomes following standalone implantation of two second-generation trabecular micro-bypass stents and postoperative topical prostaglandin in eyes with open-angle glaucoma not controlled on two preoperative medications.DesignThe study design is a prospective, nonrandomized, open-label study at a tertiary-care ophthalmology centre.ParticipantsSubjects had open-angle glaucoma with preoperative intraocular pressure of 18-30 mmHg on two medications, a medication washout phase, and post-washout intraocular pressure of 22-38 mmHg. All subjects (N = 53) have been followed for 18 months.MethodsOne day following implantation of two second-generation trabecular micro-bypass stents, subjects started topical travoprost. Medication washout was repeated at month 12.Main outcome measuresThe main outcome measure was the proportion of eyes with intraocular pressure reduction ≥ 20% versus medicated baseline intraocular pressure with reduction of one medication at 12 months.ResultsAt 12 months, 91% of eyes achieved intraocular pressure reduction ≥ 20% with reduction of one medication. All eyes had intraocular pressure ≤ 18 mmHg with reduction of one medication, and 87% had intraocular pressure ≤ 15 mmHg. Mean intraocular pressure on one medication was ≤ 13.0 mmHg (≥ 34% reduction) through 18 months. Mean post-washout intraocular pressure at month 13 was 33% lower than preoperative unmedicated intraocular pressure. No adverse events occurred through 18 months.Conclusions and relevanceIn open-angle glaucoma eyes on two preoperative medications, treatment with two second-generation trabecular stents and one postoperative prostaglandin resulted in mean intraocular pressure ≤ 13 mmHg with reduction of one medication, with favourable safety. These findings show the utility of second-generation trabecular bypass with postoperative prostaglandin in patients with open-angle glaucoma.

Project description:BackgroundThe short- and medium-term outcomes of iStent have been extensively studied; however, only few studies have investigated its long-term outcomes. Here, we assessed the long-term efficacy and safety of two iStents with concomitant cataract surgery in glaucomatous eyes while also evaluating measures of disease stability using visual field and optical coherence tomography (OCT) of the optic nerve and the macula throughout 8 years of follow-up.MethodsThis longitudinal, single-center consecutive case series included glaucomatous eyes that underwent implantation of two first-generation trabecular micro-bypass stents (iStent) with concomitant cataract surgery. Eight-year efficacy outcomes included mean intraocular pressure (IOP) and medications, as well as surgical success. Eight-year safety outcomes included best-corrected visual acuity (BCVA), visual field mean deviation (VF-MD), cup-to-disc ratio (CDR), retinal nerve fiber layer (RNFL) thickness, ganglion cell-inner plexiform layer (GC-IPL) thickness, and adverse events.ResultsA total of 62 eyes with primary open-angle glaucoma (POAG) were included. At 8 years postoperative, IOP reduced by 26% from 19.2 ± 3.9 mmHg preoperatively to 14.2 ± 2.4 mmHg (P < 0.001), 91.1% of eyes achieved IOP ≤ 18 mmHg (vs. 51.6% preoperatively), 69.6% of eyes achieved IOP ≤ 15 mmHg (vs. 14.5% preoperatively), and 25% of eyes achieved IOP ≤ 12 mmHg (vs. 1.6% preoperatively). Medication use decreased by 17.9% from 2.8 ± 1.1 preoperatively to 2.3 ± 1.2 (P = 0.018). Surgical success was 90%, as six eyes underwent subsequent glaucoma surgeries. Safety measures of BCVA, CDR, RNFL thickness and GC-IPL thickness remained stable through 8 years postoperative. VF-MD remained stable until postoperative year 5 and subsequently progressed according to the natural history of glaucomatous disease.ConclusionsImplantation of two iStents with concomitant cataract surgery is an effective and safe treatment option for surgery-naïve POAG eyes, evidenced by significant IOP and medication reductions, reasonable surgical success, and favorable safety outcomes, throughout the 8-year follow-up. Our data additionally supports the efficacy of this combined procedure in stabilizing or slowing disease progression.

Project description:BackgroundTo compare the efficacy of Ex-PRESS implantation versus trabeculectomy combined with phacoemulsification.MethodsA retrospective 12-month study on patients with coincident primary open-angle glaucoma (POAG) and cataract. The patients underwent combined phacoemulsification and Ex-PRESS implant (Phaco-ExPRESS, n = 35) or phacotrabeculectomy (Phaco-Trab, n = 35). The morphological structures of the filtering bleb were examined by slit-lamp, anterior segment optical coherence tomography (AS-OCT) and in vivo confocal microscopy (IVCM). Complete success was defined as postoperative intraocular pressure (IOP) < 18 mmHg without the use of anti-glaucoma medication. Qualified success was defined as postoperative IOP < 18 mmHg with or without anti-glaucoma medications. The data were collected preoperatively and postoperatively at 2 weeks, 1 month, 3 months, 6 months, and 12 months.ResultsNo significant difference in the variables such as age, IOP and perimetry was found between the groups of Phaco-ExPRESS and Phaco-Trab. At the one-year postoperative visit for filtering blebs, Phaco-ExPRESS increased the mean area of epithelial microcysts significantly from 0.10 ± 0.05 to 0.20 ± 0.09 μm2 per μm2, while Phaco-Trab decreased the mean area significantly from 0.08 ± 0.04 to 0.04 ± 0.06 μm2 per μm2. Notably, the hyperreflective dots detected by IVCM decreased by 84.9% in Phaco-ExPRESS but increased by 36.3% in Phaco-Trab. The hyperreflective dots were further identified as neutrophil- and monocyte-like cells. The number of these cells were negatively correlated with the microcysts area (r = - 0.7, P < 0.01) but positively associated with the grade of connective tissue (r = 0.5, P < 0.01). By creating different microstructural changes in the filtering blebs, Phaco-ExPRESS produced a higher complete success rate (84.9% vs. 41.2%, P < 0.01) and significant decrease in the number of anti-glaucoma medications (P < 0.01) when compared with those in Phaco-Trab. However, the qualified success showed no significant difference between the two groups (100.0% vs. 91.2%, P = 0.24).ConclusionsAt the one-year follow-up, Phaco-ExPRESS generated better filtering bleb with larger area of microcysts, looser connective tissues, and less inflammation than that of Phaco-Trab, providing adequate IOP control and less IOP-lowering medications. These findings indicate that Phaco-ExPRESS could be more preferred than Phaco-Trab for the treatment of patients with coincident POAG and cataract.

Project description:PurposeThe study aimed to compare the 12-month post-operative outcomes of iStent and iStent inject W (inject W), and the factors associated with their success in open-angle glaucoma.MethodsThis single-center, retrospective comparative case series evaluated the medical records of patients who underwent iStent (comprising 1 stent) or inject W (comprising 2 stents) implantation with cataract surgery for primary open-angle glaucoma and normal tension glaucoma between January 2019 and March 2022. The 12-month post-operative efficacy outcomes included intraocular pressure (IOP), glaucoma medications, and survival analysis of the probability of success. "Failure" was defined as any of the following conditions compared to baseline: 1) IOP elevation, 2) increased glaucoma medication, or 3) IOP decline not exceeding 20% when glaucoma medication scores were comparable, and 4) need for additional glaucoma surgery. The safety outcomes included intra- and post-operative adverse events and changes in the best-corrected visual acuity and visual field.ResultsThe study comprised 55 eyes in the iStent and 105 in the inject W groups. At 12 months, treatment success was achieved in 66.0% of iStent and 78.4% of inject W eyes. The mean IOP was lower, and the percent reduction from baseline was equal in iStent-treated eyes (8.0% reduction, 14.8 mmHg to 13.7 mmHg, P<0.01) and inject W-treated eyes (11.9% reduction, 15.0 mmHg to 13.8 mmHg, P<0.01) (between-group comparison, P = 0.23). The mean medication burden decreased significantly from 2.5 to 1.1 for iStent (55.0% reduction, P<0.01) and 2.9 to 1.7 for iStent inject (46.8% reduction, P<0.01), with no significant differences between the two groups (P = 0.17). Both devices exhibited excellent safety.ConclusionsBoth devices significantly reduced IOP and glaucoma medication 12 months post-operatively. The outcome measures did not differ significantly between the two groups, and lower baseline IOP was predictive of surgical failure.

Dataset Information

Micro-Bypass Implantation for Primary Open-Angle Glaucoma Combined with Phacoemulsification: 4-Year Follow-Up.

Publications

Micro-Bypass Implantation for Primary Open-Angle Glaucoma Combined with Phacoemulsification: 4-Year Follow-Up.

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