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Combined phacoemulsification and viscocanalostomy with Ologen implant versus combined phacoemulsification and viscocanalostomy.

ABSTRACT: BACKGROUND:To study the efficacy of the biodegradable collagen implant Ologen® as an adjuvant in phaco-viscocanalostomy in patients with coexisting cataract and primary open angle glaucoma. METHODS:This prospective, interventional, randomized clinical study was done at Alpha Vision Center, Zagazig, Egypt. Patients with coexisting cataract and glaucoma were randomized to receive either phaco-viscocanalostomy (Phacovisco group) (39 eyes) or phaco-viscocanalostomy with Ologen® implant (OloPhacovisco group) (40 eyes). Follow-up period was 2?years. Nd:YAG laser goniopuncture was done in cases where the intraocular pressure (IOP) was elevated above 21?mmHg after discontinuation of corticosteroid eye drops at any follow-up visit. RESULTS:No significant operative or postoperative complications (other than failure) were encountered in either group. At 2?years follow-up, the mean IOP level was statistically significantly decreased in the OloPhacovisco group (p?=?0.02) and complete success occurred in 23 eyes (59.0%) in the Phacovisco group and in 32 eyes (80.0%) in the OloPhacovisco group. There was a statistically significant higher success rate regarding complete success in patients that received Ologen® implant (p?=?0.04). CONCLUSIONS:Ologen® implant improved the success rate of phaco-viscocanalostomy. Larger studies with longer follow-up periods may be required to confirm these findings. TRIAL REGISTRATION:This trial was retrospectively registered on 20/12/2018 under the number ( NCT03782051 ).

SUBMITTER: Gad AAM

PROVIDER: S-EPMC6364460 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Combined phacoemulsification and viscocanalostomy with Ologen implant versus combined phacoemulsification and viscocanalostomy.

Gad Ahmed A M AAM Abdulhalim Bahaa-Eldin Hasan BH Lotfy Ayman A Abdelrahman Ayman Mohamed AM Ahmed Ahmed Samir AS

BMC ophthalmology 20190206 1

<h4>Background</h4>To study the efficacy of the biodegradable collagen implant Ologen® as an adjuvant in phaco-viscocanalostomy in patients with coexisting cataract and primary open angle glaucoma.<h4>Methods</h4>This prospective, interventional, randomized clinical study was done at Alpha Vision Center, Zagazig, Egypt. Patients with coexisting cataract and glaucoma were randomized to receive either phaco-viscocanalostomy (Phacovisco group) (39 eyes) or phaco-viscocanalostomy with Ologen® implan ...[more]

PMID: 30727982

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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.

Project description:BackgroundVarious surgical techniques have been described, to be combined with cataract surgery in glaucoma patients, aiming for an additional reduction of intraocular pressure (IOP), hence minimizing the burden of anti-glaucoma medication (AGM). Ultrasound ciliary plasty (UCP) is a recent microinvasive glaucoma surgery (MIGS) recommended for primary and refractory glaucoma. This study was conducted to evaluate the safety and efficacy of a new technique; combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP) as a primary surgical treatment for coexisting cataract and open angle glaucoma.MethodsA randomized clinical trial, including 61 eyes of 61 patients with visually significant cataract and open angle glaucoma, randomized to either Phaco-UCP (study group; 31 eyes) or phacoemulsification alone (Phaco-alone) (control group; 30 eyes). Primary outcomes included reduction in IOP and/or the number of AGM. Secondary outcomes included visual acuity improvement and complications. Qualified Success was defined as an IOP reduction ≥ 20% from baseline value, with an IOP 6-21 mmHg, with no additional AGM or glaucoma surgery. Failure was defined as either < 20% IOP reduction, despite AGM use, the need of glaucoma surgeries or serious complications.ResultsAt 18 months postoperatively, Phaco-UCP group had a median IOP reduction of 7 mmHg (Q1, Q3 = 3, 10) compared to 2 mmHg (Q1, Q3 = 2, 3) in Phaco-alone group (P < 0.001). Phaco-UCP group had significantly higher success rate at all time points reaching 67.7% at the last follow-up versus 16.7% only in Phaco-alone group (P< 0.001). The median number of AGM significantly decreased from [3 (Q1, Q3 = 2, 4), 3 (Q1, Q3 = 2,3)] respectively, (P =0.3)] at baseline to [1 (Q1,Q3 = 1, 2), 2 (Q1,Q3 = 2, 2)] respectively, (P < 0.001)] at 18 months postoperatively. No serious intraoperative or postoperative complications were encountered in either group.ConclusionPhaco-UCP is a simple, safe and effective procedure for management of coexisting cataract and open angle glaucoma.Trial registrationClinicalTrials.gov identifier, NCT04430647 ; retrospectively registered. June 12, 2020.

Project description:BackgroundMinimally invasive glaucoma surgeries (MIGS) have attracted significant attention, as they have been reported to lower intra-ocular pressure (IOP) and have an excellent safety profile. The iStent is an example of a minimally invasive glaucoma device that has received particular attention due to its early and wide spread utilization. There is a growing body of evidence supporting its use at the time of phacoemulsification to help lower IOP. However, it is still not clear how much of the IOP lowering effect can be attributed to the iStent, the crystalline lens extraction or both when inserted concurrently at the time of phacoemulsification. This has been an important issue in understanding its potential role in the glaucoma management paradigm.PurposeTo conduct a systematic review and meta-analysis comparing the IOP lowering effect of iStent insertion at the time of phacoemulsification versus phacoemulsification alone for patients with glaucoma and cataracts.MethodsA systematic review was conducted utilizing various databases. Studies examining the IOP lowering effect of iStent insertion in combination with phacoemulsification, as well as studies examining the IOP lowering effect of phacoemulsification alone were included. Thirty-seven studies, reporting on 2495 patients, met the inclusion criteria. The percentage reduction in IOP (IOPR%) and mean reduction in topical glaucoma medications after surgery were determined. The standardized mean difference (SMD) was computed as a measure of the treatment effect for continuous outcomes taking into account heterogeneity. Fixed-effect and random-effect models were applied.ResultsA 4% IOP reduction (IOPR%) from baseline occurred following phacoemulsification as a solo procedure compared to 9% following an iStent implant with phacoemulsification, and 27% following 2 iStents implants with phacoemulsification. Compared with cataract extraction alone, iStent with phacoemulsification resulted in significant reduction in the post-operative IOP (IOPR%) (SMD = -0.46, 95% CI: [-0.87, -0.06]). A weighted mean reduction in the number of glaucoma medications per patient was 1.01 following phacoemulsification alone compared to 1.33 after one iStent implant with phacoemulsification, and 1.1 after 2 iStent implants with phacoemulsification. Compared to cataract extraction alone, iStent with cataract extraction showed a significant decrease in the number of glaucoma medications (SMD = -0.65, 95% CI: [-1.18, -0.12]). Funnel plots suggested the absence of publication bias.ConclusionBoth iStent implantation with concurrent phacoemulsification and phacoemulsification alone result in a significant decrease in IOP and topical glaucoma medications. In terms of both reductions, iStent with phacoemulsification significantly outperforms phacoemulsification alone.

Project description:Purpose To compare the effectiveness and safety of phacoemulsification combined with endoscopic cyclophotocoagulation (phaco/ECP), phacoemulsification combined with MicroPulse transscleral cyclophotocoagulation (phaco/MP-TSCPC), and phacoemulsification alone (phaco) in the treatment of coexisting cataract and glaucoma. Methods Retrospective cohort study of consecutive cases at Massachusetts Eye & Ear. The main outcome measures were the cumulative probabilities of failure between the phaco/ECP group, phaco/MP-TSCPC group, and the phaco alone group with failure defined as reaching NLP vision at any point postoperatively, undergoing additional glaucoma surgery, or the inability to maintain ≥ 20% IOP reduction from baseline with IOP between 5–18 mmHg while maintaining ≤ baseline medications. Additional outcome measures included changes in average IOP, number of glaucoma medications, and complication rates. Results Sixty-four eyes from 64 patients (25 phaco/ECP, 20 phaco/MPTSCPC, 19 phaco alone) were included in this study. The groups did not differ in age (mean 71.04 ± 6.7 years) or length of follow-up time. Baseline IOPs were significantly different between groups (15.78 ± 4.7 mmHg phaco/ECP, 18.37 ± 4.6 mmHg phaco/MP-TSCPC, 14.30 ± 4.2 mmHg phaco alone, p = 0.02). Primary open-angle glaucoma was the most common type of glaucoma in the phaco alone (42%) and phaco/ECP (48%) groups while mixed-mechanism glaucoma was the most common type in the phaco/MP-TSCPC group (40%). Surgical failure was less likely in eyes in the phaco/MP-TSCPC (3.40 times, p = 0.005) and phaco/ECP (1.40 times, p = 0.044) groups compared to phaco alone based on the Kaplan–Meier survival criteria. These differences maintained statistical significance when differences in preoperative IOP were taken into account using the Cox PH model (p = 0.011 and p = 0.004, respectively). Additionally, surgical failure was 1.98 times less likely following phaco/MP-TSCPC compared to phaco/ECP (p = 0.038). This difference only approached significance once differences in preoperative IOP were accounted for (p = 0.052). There was no significant difference in IOP reduction at 1 year between groups. Mean IOP reductions at 1 year were 3.07 ± 5.3 mmHg from a baseline of 15.78 ± 4.7 in the phaco/ECP group, 6.0 ± 4.3 mmHg from a baseline of 18.37 ± 4.6 in the phaco/MP-TSCPC group and 1.0 ± 1.6 from a baseline of 14.30 ± 4.2 mmHg in the phaco alone group. There were no differences in complication rates among the three groups. Conclusions Both Phaco/MP-TSCPC and phaco/ECP appear to provide superior efficacy for IOP control when compared to phaco alone. All three procedures had similar safety profiles. Supplementary Information The online version contains supplementary material available at 10.1186/s12886-023-02877-6.

Dataset Information

Combined phacoemulsification and viscocanalostomy with Ologen implant versus combined phacoemulsification and viscocanalostomy.

Publications

Combined phacoemulsification and viscocanalostomy with Ologen implant versus combined phacoemulsification and viscocanalostomy.

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