Cholesterol-Lowering Drugs and Incident Open-Angle Glaucoma: A Population-Based Cohort Study

Background: Open-angle glaucoma (OAG) is a progressive neurodegenerative disease that may lead to blindness. An elevated intraocular pressure (IOP) is its major risk factor. OAG treatment is currently exclusively directed towards the lowering of the IOP. IOP lowering does not prevent disease progression in all patients and thus other treatment modalities are needed. Earlier studies reported cholesterol-lowering drugs to have neuroprotective properties. The aim of this study was to determine the associations between the use of cholesterol-lowering drugs and incident OAG. Methodology/Principal Findings: Participants in a prospective population-based cohort study underwent ophthalmic examinations, including IOP measurements and perimetry, at baseline and follow-up. The use of statins and non-statin cholesterol-lowering drugs was monitored continuously during the study. Associations between the use of cholesterol-lowering drugs and incident OAG were analyzed with Cox regression; associations between cholesterol-lowering drugs and IOP at follow-up were analyzed with multiple linear regression. During a mean follow-up of 9.8 years, 108 of 3939 eligible participants (2.7%) developed OAG. The hazard ratio for statin use was 0.54 (95% confidence interval 0.31-0.96; P = 0.034) and for non-statin cholesterol-lowering drugs 2.07 (0.81-5.33; P = 0.13). The effect of statins was more pronounced with prolonged use (hazard ratio 0.

Glaucoma drainage device surgery after vitreoretinal surgery:incidence and risk factors

Purpose: The initial success of vitreoretinal surgery can be annihilated by an acceleration of preexisting glaucoma or the development of secondary glaucoma. Aim of this study was to determine the incidence of and risk factors for medically uncontrollable glaucoma after vitreoretinal surgery. Methods: Case-control study amongst patients who underwent vitreoretinal surgery at the University Medical Center Groningen between 1991 and 2011 (in total 14 942 interventions). Cases were all patients who received a glaucoma drainage device after vitreoretinal surgery. Controls were a subset of the patients who underwent vitreoretinal surgery without a subsequent drainage device. Cases and controls were matched (three controls per case) with regard to the year of the (first) vitreoretinal intervention. The incidence rate was calculated from the number of cases and the number of person-years corresponding to all vitreoretinal interventions performed in the study period. Risk factors were analysed with logistic regression. Results: Ninety-five cases were identified after a follow-up of 101 961 personyears (one per 1000 person-years). Cases were younger (p = 0.017), were more often men (p = 0.035), underwent more interventions (p <0.001) or were treated with silicone oil (p = 0.021), had a higher intra-ocular pressure 1 week after the intervention (p <0.001) and had more often a history of glaucoma or ocular hypertension (p <0.001). Conclusion: Glaucoma after vitreoretinal surgery that requires a glaucoma drainage device is not very common and patients who need a device differ from those who do not. This gives the opportunity to monitor certain subgroups more closely

Antithrombotic Medication and Incident Open-Angle Glaucoma

PURPOSE. To determine the associations between the use of antithrombotic drugs and incident open-angle glaucoma (OAG). METHODS. Ophthalmic examinations including measurements of the IOP and perimetry were performed at baseline and follow-up in 3939 participants of the prospective population-based Rotterdam Study who did not have OAG at baseline. The use of antithrombotic drugs was monitored continuously during follow-up. Antithrombotic drugs were stratified into anticoagulants and platelet aggregation inhibitors. Associations between incident OAG and the use of antithrombotic drugs were assessed using Cox regression; the model was adjusted for age, sex, baseline IOP and IOP-lowering treatment, family history of glaucoma, and myopia. Associations between antithrombotic drugs and IOP at follow-up were analyzed with multiple linear regression. RESULTS. During a mean follow-up of 9.8 years, 108 participants (2.7%) developed OAG. The hazard ratio for anticoagulant use was 0.90 (95% confidence interval [CI], 0.55-1.48; P = 0.69) and for platelet aggregation inhibitors 0.80 (0.53-1.21; P = 0.28). There was no trend towards a reduced or increased risk of incident OAG with prolonged anticoagulant use (P value for trend 0.84) or platelet aggregation inhibitor use (0.59). There was a significant IOP-lowering effect of anticoagulants (-0.31 mm Hg; 95% CI, -0.58 to -0.04 mm Hg; P = 0.025) but not of platelet aggregation inhibitors (P = 0.06). The IOP-lowering effect of anticoagulants disappeared after additional adjustment for the use of systemic beta-blockers. CONCLUSIONS. Use of anticoagulants or platelet aggregation inhibitors appears not to be associated with incident OAG. (Invest Ophthalmol Vis Sci. 2012;53:3801-3805) DOI:10.1167/iovs.12-960

Baseline characteristics of participants with and without incident open-angle glaucoma (A) and of cholesterol-lowering drug users (either statins or NSCLDs, or both) and non-users (B), with univariable comparisons (mean values with standard deviation between brackets unless stated otherwise).

<p>NSCLDs = non-statin cholesterol-lowering drugs; IOP = intraocular pressure.</p

Final multivariate model of the risk of developing open-angle glaucoma for cholesterol-lowering medication.

<p>NSCLDs = non-statin cholesterol-lowering drugs; IOP = intraocular pressure.</p

Multiple linear regression analysis with intraocular pressure at follow-up as the dependent variable.

<p>IOP = intraocular pressure.</p

Univariable analyses of the use of cholesterol-lowering medication at any time during follow-up and the development of open-angle glaucoma.

<p>NSCLDs = non-statin cholesterol-lowering drugs.</p

Effectiveness and cost-effectiveness of MicroShunt implantation versus standard trabeculectomy for open-angle glaucoma (a SIGHT study): study protocol of a multicentre randomised controlled trial

Abstract Background Trabeculectomy is the “gold standard” initial surgical procedure for open-angle glaucoma worldwide. During the last decade, the introduction of less invasive procedures, including new bleb-forming surgery such as the MicroShunt, has altered the approach of glaucoma management. At present, there is insufficient evidence comparing the effectiveness between these procedures nor versus trabeculectomy. Furthermore, there is no data available on patient impact and cost-effectiveness. This study aims to address this gap in evidence and establish whether MicroShunt implantation is non-inferior compared to trabeculectomy with regard to effectiveness and whether it is cost-effective. Methods A multicentre, non-inferiority, randomised controlled trial (RCT) studying open-angle glaucoma with an indication for surgery will be conducted. Patients with previous ocular surgery except for phacoemulsification are excluded, as are patients with ocular comorbidity compromising the visual field or requiring a combined procedure. After informed consent is obtained, patients will be randomly allocated to the intervention, a PRESERFLO™ MicroShunt implantation, or the control group, trabeculectomy, using block randomisation (blocks of 2, 4 or 6 patients). In total, 124 patients will be randomised in a 1:1 ratio, stratified by centre. The primary endpoint will be intraocular pressure (IOP) one year after surgery. Secondary outcomes include IOP-lowering medication use, treatment failure, visual acuity, visual field progression, additional interventions, adverse events, patient-reported outcome measures (PROMs), and cost-effectiveness. Study outcomes will be measured up to 12 months postoperatively. Discussion This study protocol describes the design of a multicentre non-inferiority randomised controlled trial. To this date, cost-effectiveness studies evaluating the MicroShunt have not been undertaken. This multicentre RCT will provide more insight into whether MicroShunt implantation is non-inferior compared to standard trabeculectomy regarding postoperative IOP and whether MicroShunt implantation is cost-effective. Trial registration ClinicalTrials.gov, Identifier: NCT03931564 , Registered 30 April 2019

Effectiveness and cost-effectiveness of MicroShunt implantation versus standard trabeculectomy for open-angle glaucoma (a SIGHT study): study protocol of a multicentre randomised controlled trial

Background: Trabeculectomy is the “gold standard” initial surgical procedure for open-angle glaucoma worldwide. During the last decade, the introduction of less invasive procedures, including new bleb-forming surgery such as the MicroShunt, has altered the approach of glaucoma management. At present, there is insufficient evidence comparing the effectiveness between these procedures nor versus trabeculectomy. Furthermore, there is no data available on patient impact and cost-effectiveness. This study aims to address this gap in evidence and establish whether MicroShunt implantation is non-inferior compared to trabeculectomy with regard to effectiveness and whether it is cost-effective. Methods: A multicentre, non-inferiority, randomised controlled trial (RCT) studying open-angle glaucoma with an indication for surgery will be conducted. Patients with previous ocular surgery except for phacoemulsification are excluded, as are patients with ocular comorbidity compromising the visual field or requiring a combined procedure. After informed consent is obtained, patients will be randomly allocated to the intervention, a PRESERFLO™ MicroShunt implantation, or the control group, trabeculectomy, using block randomisation (blocks of 2, 4 or 6 patients). In total, 124 patients will be randomised in a 1:1 ratio, stratified by centre. The primary endpoint will be intraocular pressure (IOP) one year after surgery. Secondary outcomes include IOP-lowering medication use, treatment failure, visual acuity, visual field progression, additional interventions, adverse events, patient-reported outcome measures (PROMs), and cost-effectiveness. Study outcomes will be measured up to 12 months postoperatively. Discussion: This study protocol describes the design of a multicentre non-inferiority randomised controlled trial. To this date, cost-effectiveness studies evaluating the MicroShunt have not been undertaken. This multicentre RCT will provide more insight into whether MicroShunt implantation is non-inferior compared to standard trabeculectomy regarding postoperative IOP and whether MicroShunt implantation is cost-effective. Trial registration: ClinicalTrials.gov, Identifier: NCT03931564, Registered 30 April 2019

Corticosteroids and Open-Angle Glaucoma in the Elderly A Population-Based Cohort Study

Background It is largely unknown if corticosteroid-induced open-angle glaucoma (OAG) is an entity that is limited to a few susceptible individuals or whether it contributes significantly to the overall population burden of OAG. Objective The aim of this study was to determine whether there is an association between corticosteroid use and the incidence of OAG in the general elderly population. Methods A prospective population-based cohort study was conducted in a general community setting. 3,939 participants of the Rotterdam Study aged 55 years and older for whom data from ophthalmic examinations at baseline and follow-up were available and who did not have glaucoma at baseline were included (baseline examination from 1991 to 1993; follow-up examinations from 1997 to 1999 and from 2002 to 2006). Ophthalmic examinations, including measurement of the intraocular pressure, assessment of the optic nerve head and perimetry, were performed at baseline and follow-up. The use of corticosteroids was monitored continuously during follow-up. Corticosteroids were stratified into five groups: ophthalmic steroids, inhaled steroids, nasal steroids, oral steroids and steroid ointments. Associations between the use of corticosteroids and incident OAG were assessed using logistic regression models. The study outcome measures were the odds ratios (ORs) of associations between the use of corticosteroids and incident OAG. Results During a mean follow-up of 9.8 years, 108 participants (2.8 %) developed OAG. The median number of steroid prescriptions during follow-up was 2 for ophthalmic, 7 for inhaled, 2 for nasal and 2 for oral steroids, and 3 for steroid ointments. The OR of the use of ophthalmic steroids was 1.04 [95 % confidence interval (CI) 0.66, 1.65; p = 0.86], inhaled steroids 0.79 (95 % CI 0.42, 1.48; p = 0.46), nasal steroids 1.26 (95 % CI 0.74, 2.13; p = 0.40), oral steroids 1.03 (95 % CI 0.65, 1.64; p = 0.89) and steroid ointments 0.70 (95 % CI 0.47, 1.05; p = 0.086). These analyses were adjusted for age, sex, high myopia and family history of glaucoma. The small median numbers of prescriptions made it difficult to evaluate dose-response relationships. Conclusion None of the classes of steroids were associated with the incidence of OAG in this elderly population