Morphology of the first metatarsal head and hallux rigidus: a cadaveric study.

PURPOSE: Treatment options for hallux rigidus include several conservative and surgical measures. The aetiology leading to the disease has not sufficiently been examined so far. MATERIALS AND METHODS: We analysed the anatomical configuration of the first metatarsal head of 120 metatarsal bones of different collectives aiming to find a possible correlation between the geometry of the first metatarsophalangeal joint and manifestation of hallux rigidus. Wet human cadaveric specimens and macerated dry specimens served as material. The relevant parameters used for analysis were an axis running through the metatarsal head, the anatomical longitudinal axis, and the radius of curvature of the first metatarsal bone. RESULTS: A significant difference was found in the radius of curvature of osteoarthritic and healthy subjects. Using the binary logistic regression, we were able to predict the probability of an occurrence of hallux rigidus in dependence of the radius of curvature. Furthermore, we were enabled to calculate a correct prediction for the appearance of osteoarthritis in 85 % of the healthy subjects, and 73 % of the osteoarthritic subjects. CONCLUSIONS: A consolidated view of the factors indicates that persons with a high risk for the appearance of hallux rigidus should be identified by measuring the radius of curvature in conventional radiographs and preventive measures to postpone the occurrence of clinically relevant hallux rigidus considered.

Cost-Utility Analysis of a Latanoprost Cationic Emulsion (STN1013001) versus Other Latanoprost in the Treatment of Open-Angle Glaucoma or Ocular Hypertension and Concomitant Ocular Surface Disease in Germany.

PURPOSE: This study aimed to estimate the cost-utility and economic value of STN1013001, a latanoprost cationic emulsion vs other latanoprost formulations (henceforth latanoprost) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) and concomitant ocular surface disease (OSD) in Germany. METHODS: An early 5-year Markov model-supported cost-utility analysis was performed to estimate costs, quality-adjusted life years (QALYs) and life-years saved (LYS) for STN1013001 vs latanoprost from the German health system perspective. The model included seven mutually exclusive health states and adopted a 1-year cycle length. The model was populated with pooled data derived, by means of a questionnaire, from a convenience sample of five German glaucoma specialists. Remaining data were derived from published sources. Data provided by the ophthalmologists included annual treatment adherence probabilities, utility values and resource utilization. The half-cycle correction as well as a discount rate of 3.0% per year were applied to costs (expressed in €2020), life-year saved (LYS) and QALYs. The incremental cost-utility ratio (ICUR) was contrasted against the informal willingness-to-pay (WTP) threshold for incremental LYS saved or QALY gained (€30,000) proposed for Germany. One-way and probabilistic sensitivity analyses (OWSA; PSA) tested the robustness of the base case ICUR. RESULTS: Over the 5-year time horizon, STN1013001 strongly dominates latanoprost as it is less costly (€1003.65 vs €1145.37; -12.37%) and produces more QALYs (2.612 vs 2.365; +10.44%) per notional patient. Baseline findings were robust against all the variations included in OWSA. PSA shows that STN1013001 has a 100% probability of being cost-effective vs Latanoprost at each WTP threshold for incremental QALY gained. CONCLUSION: Once on the market, STN1013001 will provide a cost-effective and possibly strongly dominant therapy vs latanoprost for OAG/OHT+OSD patients from a German health system perspective. Future empirical research should confirm these findings.

Success rates of retinal buckling surgery: relationship to refractive error and lens status: results from a large German case series.

OBJECTIVE: First, to evaluate the anatomic success rates of scleral buckling surgery in the treatment of rhegmatogenous retinal detachment and possible differences in outcome depending on patients' refractive error and lens status. Second, to evaluate demographic characteristics of patients with retinal detachment to contribute to our knowledge of the epidemiology of this important and sight-threatening disease. DESIGN: Retrospective interventional case series. PARTICIPANTS: The Munster Study on Therapy Achievements in Retinal Detachment (MUSTARD) is one of the largest case series of patients with retinal detachment and their outcome after buckling surgery ever established, with 4325 subjects who underwent surgery between 1980 and 2001. METHODS: All 4325 patients with retinal detachment underwent scleral buckling surgery. MAIN OUTCOME MEASURES: Complete anatomic attachment of the retina. RESULTS: The overall success rate in all 4325 MUSTARD cases was 83.98%. The highest success rate was achieved in patients aged 51 to 60 years, with 86.72%. With regard to refractive error, success rates were highest in moderate myopes, that is, in 707 patients with a refractive error between -2.75 and -8.0 diopters (86.70%) and in 573 patients with mild myopia between -0.5 and -2.0 diopters (86.21%). The lens status did not play a significant role in outcome. In patients with nontrauma-related retinal detachment, success rates were 84.45% for phakic patients, 82.88% for pseudophakic patients, and 81.88% for aphakic patients. An epidemiologically surprising result was the lower than expected number of myopic individuals among patients with retinal detachment: Only approximately one quarter had myopia of -2.75 diopters or more. In phakic patients aged 51 to 80 years, only 16% were myopic. CONCLUSIONS: Scleral buckling is an established and generally successful method for the treatment of retinal detachment. As our case series has demonstrated, myopia, aphakia, and pseudophakia do not constitute factors that might diminish the chances of success. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Manual stimulation, but not acute electrical stimulation prior to reconstructive surgery, improves functional recovery after facial nerve injury in rats.

UNLABELLED: The outcome of peripheral nerve injuries requiring surgical repair is poor. Recent work suggested that electrical stimulation (ES) of the proximal nerve stump to produce repeated discharges of the parent motoneurons for one hour could be a beneficial therapy if delivered immediately prior to reconstructive surgery of mixed peripheral nerves. PURPOSE: We tested whether ES has a positive influence on functional recovery after repair of a purely motor nerve, the facial nerve. METHODS: Electrical stimulation (20 Hz) was delivered to the proximal nerve stump of the transected facial nerve for 1 hour prior to nerve reconstruction by end-to-end suture (facial-facial anastomosis, FFA). For manual stimulation (MS), animals received daily rhythmic stroking of the whisker pads. Restoration of vibrissal motor performance following ES or MS was evaluated using video-based motion analysis. We also assessed the degree of collateral axonal branching at the lesion site, by counting motoneuronal perikarya after triple retrograde labeling, and estimated the quality of motor end-plate reinnervation in the target musculature. Outcomes at 4 months were compared to animals receiving sham stimulation (SS) or MS. RESULTS: Neither protocol reduced the degree of collateral sprouting. ES did not improve functional outcome and failed to reduce the proportion of polyinnervated motor end-plates. By contrast, MS restored normal whisking function and reduced polyinnervation. CONCLUSION: Whereas acute ES is not beneficial for facial nerve repair, MS provides long-term benefits.

Aflibercept for Patients with Neovascular Age-Related Macular Degeneration in Routine Clinical Practice in Germany: Twelve-Month Outcomes of PERSEUS.

PURPOSE: To explore real-world effectiveness of intravitreal aflibercept injection (IAI) for neovascular age-related macular degeneration (nAMD) in Germany. DESIGN: A 24-month, prospective, noninterventional, noncontrolled, multicenter observational cohort study. PARTICIPANTS: Patients (n = 848) with nAMD treated with IAI. METHODS: Patients (n = 988) were screened at 67 study sites. Therapeutic decisions were made by the treating physician. Primary end point analysis was performed after 12 months for the entire study cohort and for predetermined subgroups of treatment-naïve and previously treated patients. Additionally, outcomes with regular injection intervals (bimonthly after 3 monthly injections) were compared with those of patients with irregularities in their treatment regimen. MAIN OUTCOME MEASURES: The primary end point was the mean change in visual acuity (VA) from baseline after 12 months. Other key end points included the proportions of patients gaining 15 letters or more and patients with reading vision (≥70 letters). Furthermore, the number of injections, anatomic measurements, and safety data were recorded. RESULTS: Mean ± standard deviation VA improvement was 5.3±17.4 letters in treatment-naïve patients and -0.1±15.6 letters in previously treated patients (P ≤ 0.0001), and that of the total study group was 2.9±16.8 letters. Baseline VA was 53.4±17.9 letters for treatment-naïve patients, 52.9±18.4 letters for previously treated patients, and 53.2±18.1 letters for the total patient population. Treatment pattern was associated with VA outcome: best outcomes-an average VA gain of 8.0±17.7 letters-were seen in treatment-naïve patients in the regularly treated population, whereas irregularly treated, treatment-naïve patients achieved a mean VA gain of only 4.0±17.1 letters. Among previously treated patients, regular treatment also was associated with better outcomes (+3.1±10.7 vs. -1.1±16.8 letters). For the total study group, the mean VA gain was the following: regularly treated population, 6.1±15.6 letters; irregularly treated population, 1.5±17.1 letters (P = 0.008). No cases of endophthalmitis were observed during the first 12 months of the study. Adverse events were in line with the known safety profile of IAI. CONCLUSIONS: After 12 months of treatment with IAI, treatment-naïve patients showed substantial functional benefit, whereas previously treated patients maintained their VA. With regular IAI treatment, it seems that similar results as those in pivotal IAI studies can be achieved in routine clinical practice.

Midterm response with latanoprost therapy in german ocular hypertension patients.

PURPOSE: The purpose of this prospective observational trial was to report the analysis of the midterm efficacy, safety, and discontinuation rates of a cohort of ocular hypertensive patients treated with latanoprost in Germany. METHODS: A subanalysis of patients with ocular hypertension who were previously treated on latanoprost monotherapy and continued within the study on this same medication for at least 6 months. RESULTS: 353 patients with ocular hypertension were included and treated with latanoprost monotherapy historically (1.4 +/- 1.3 years) and within the observational period of the study for a mean of 2.2 +/- 1.1 years. On latanoprost only, the average intraocular pressure at study entry was 18.4 +/- 2.7 mm Hg, and at 6 months the intraocular pressure was 18.3 +/- 2.3 mmHg (p = 0.54). During the observational period, the most common ocular side effect was conjunctival hyperemia (20.7%), and the most common systemic side effect was fatigue (3.1%). Nineteen patients (5.4%) discontinued latanoprost with the most common reason being insufficient efficacy (3.1%). Physician assessments of latanoprost monotherapy were "very good" to "excellent" for patient efficacy (75.2%), tolerability (83.8%), and patient satisfaction (82.1%). CONCLUSIONS: The study suggests that patients with ocular hypertension already treated with latanoprost monotherapy will continue to have, on average, at least midterm stable pressures, low incidence of side effects and discontinuations, as well as "very good" to "excellent" physician ratings of efficacy, tolerability, and patient satisfaction.

Clinical experience in the treatment of normal tension glaucoma with latanoprost in Germany.

AIMS: The aim of this analysis was to evaluate the general ophthalmologist's experience in using latanoprost to treat normal tension glaucoma (NTG) patients. METHODS: NTG patients included in this study were part of an observational cohort of patients that were changed from previous therapy to latanoprost in Germany. RESULTS: This study included 200 NTG glaucoma patients who were being treated with latanoprost monotherapy (average duration, 1.2 +/- 1.4 years) and had 6 months of follow-up. At the beginning of the observation period, patients had an average intraocular pressure (IOP) of 15.2 +/- 2.5 mmHg and after 6 months, 15.0 +/- 2.4 mmHg (P = 0.769). Eight (8) patients (4.0%) were discontinued from latanoprost during the observation period, with the most common reason noted as the need for further IOP reduction (n = 7; 3.5%). Twenty-four (24) patients (12.0%) noted at least one ocular adverse event during the observation period, with the most common reason noted as burning/stinging (n = 9; 4.5%) or conjunctival hyperemia (n = 9; 4.5%). CONCLUSIONS: This study suggests that patients with NTG who are already treated with latanoprost monotherapy should continue to have, over a short-term follow-up, generally stable IOPs, low side-effect incidence, and discontinuations, as well as "very good" to "excellent" physician ratings of patient efficacy, tolerability, and satisfaction.

Preservative-free bimatoprost 0.03% in patients with primary open-angle glaucoma or ocular hypertension in clinical practice.

BACKGROUND: Intraocular pressure (IOP)-lowering medications for primary open-angle glaucoma and ocular hypertension commonly contain preservatives that can cause ocular surface damage in many patients. The purpose of this study was to evaluate the efficacy and tolerability of, and compliance to, preservative-free (PF) bimatoprost 0.03% in patients with primary open-angle glaucoma or ocular hypertension (IOP ≥18 mmHg) in a clinical practice setting. METHODS: This open-label study observed patients who were switched to PF bimatoprost 0.03% for medical reasons. IOP was measured at baseline and ~12 weeks later at the final visit, and the change in IOP was calculated. Tolerability and continuation of therapy were assessed at two follow-up visits. RESULTS: A total of 1,830 patients were included in the study, and complete IOP data were available for 1,543 patients. Mean IOP was reduced by 23% from 21.64 mmHg to 16.59 mmHg (P<0.0001). In subgroup analyses, the mean IOP was significantly reduced compared with baseline, regardless of prior therapy, including those previously treated with PF monotherapy. A total of 85.7% of physicians reported the IOP-lowering efficacy of PF bimatoprost 0.03% to be as expected or better than expected. Adverse events (AEs) were experienced by 5.7% of patients, and there were no serious AEs reported. The most common AEs were eye irritation (1.7%) and hyperemia (1.4%). Physician-reported treatment compliance was reported as better than (48.7%) or equal to (43.6%) prior treatment in most patients. Most patients (82%) were expected to continue PF bimatoprost 0.03% after the end of the study. CONCLUSION: This observational study showed that, in clinical practice, switching to PF bimatoprost 0.03% was associated with a significant IOP reduction from baseline. There was a low AE rate. PF bimatoprost 0.03% may, therefore, be an effective treatment option for patients who are intolerant of preservatives or have an inadequate response to prior IOP-lowering treatments.

A prospective, multicenter, noninterventional study of Optive Plus(®) in the treatment of patients with dry eye: the prolipid study.

OBJECTIVE: The aim was to evaluate the efficacy of Optive Plus(®), an artificial tear containing castor oil, in patients with dry eye, in a routine clinical setting. METHODS: This was a prospective, noninterventional study of patients with dry eye who switched from a prior therapy or who were naïve to treatment (n=1,209). Patients were issued Optive Plus(®) artificial tears. Dry eye severity, tear break-up time (TBUT), Schirmer score, Ocular Surface Disease Index (OSDI) score, and patient assessment of symptoms were recorded at baseline and at the follow-up visit (4 weeks after starting Optive Plus(®)). RESULTS: The cause of dry eye was determined to be aqueous deficiency, lipid deficiency, or a mixture of aqueous and lipid deficiency (in 19.5%, 20.1%, and 47.8%, respectively, of the total study population). The severity of dry eye decreased from baseline to the follow-up visit, showing a decrease of the more severe levels (2-4) and a concurrent increase in mild level (1) of the rating scale. Patients reported an improvement in dry eye symptoms over the duration of the study, specifically 74.2% (n=152), 85.4% (n=182), and 82.4% (n=417) of patients in the aqueous-deficient, lipid-deficient, and mixed-deficiency groups, respectively. TBUT was measured in 475 patients. Baseline measurements for mean and standard deviation were 9.0±3.5, 7.1±3.6, and 6.6±3.0 seconds for the aqueous-deficient, lipid-deficient, and mixed-deficiency groups, respectively. These increased to 10.5±3.5, 10.0±3.6, and 9.2±3.1 seconds at the final visit. Overall, 92.5% of all patients were satisfied with the use of Optive Plus(®), and 86% said they would purchase Optive Plus(®). Ten percent of patients reported adverse events, and 1.8% of all patients experienced treatment-related adverse events. CONCLUSION: Optive Plus(®) was well tolerated and effective in reducing the signs and symptoms of all types of dry eye but is recommended for lipid-deficient dry eye patients.

The treatment of proximal humeral fracture in adults.

BACKGROUND: The incidence of proximal humeral fractures lies between 105 and 342 per 100 000 persons per year. Around the world, this type of fracture remains a major challenge for treating surgeons. While non-displaced fractures can be managed conservatively, displaced ones are often treated surgically. METHODS: Selective literature review. RESULTS: There are still no evidence-based schemes or guidelines for the treatment of proximal humeral fractures, and very few prospective randomized trials are available. The few that have been published recently show a trend in favor of conservative treatment, but they were carried out on small groups of patients and their findings are not directly generalizable. For younger patients, the goal of treatment is generally anatomical repositioning and osteosynthetic stabilization; for older patients, primary treatment with a prosthesis is a further option. Depending on the mode of treatment, complications can arise such as shoulder stiffness, necrosis of the humeral head, pain, infection, loss of reposition, and "cutting out." CONCLUSION: Current evidence supports the individualized treatment of proximal humeral fractures. Treatment decisions must always be made jointly with the patient in consideration of his or her individual needs and characteristics. Particularly for elderly patients, the possibility of conservative treatment should be carefully considered. If conservative treatment is not possible, then the type of operation performed should also be a function of the surgeon's individual skills and experience with particular types of implant.

Long-term cost and efficacy analysis of latanoprost versus timolol in glaucoma patients in Germany.

AIM: To evaluate 5-year effectiveness and cost between latanoprost or timolol monotherapy in a pilot trial. METHODS: A retrospective, multi-center trial performed at 6 sites in Germany of patients who had a diagnosis of primary open-angle or pigmentary glaucoma, in at least one eye, initiated on monotherapy with latanoprost or timolol maleate. Qualified consecutive charts were reviewed in which 5-year efficacy, safety and cost data was abstracted. RESULTS: Seventy-seoen latanoprost and 49 timolol patients were included, at the final visit no difference existed between the two groups in disc parameters including: rim area, rim area/disc area ratio, cup volume or vertical cup/disc ratio (P>0.05). There was no difference in intraocular pressure (IOP) between the initial latanoprost (17.4±2.6) and timolol (16.3±2.8mmHg) groups. There was less change in medicines over the follow-up period (0.1 vs 0.8) and fewer medications at the final visit (1.2 vs 1.8) with latanoprost compared to timolol. No patient treated with latanoprost discontinued therapy during follow-up, while 12% discontinued timolol mostly due to inadequate IOP control. Cost/year was less with initial timolol ($458±236) as compared to latanoprost ($552±202). CONCLUSION: Patients begun on latanoprost or timolol and followed over 5 years may have similar clinical outcomes. However, timolol patients may require more medicines and medicine changes to control IOP for long-term, but at a lower cost.

Outcome of surgery after macula-off retinal detachment - results from MUSTARD, one of the largest databases on buckling surgery in Europe.

PURPOSE: To evaluate the anatomical success rate of scleral buckling surgery in the treatment of rhegmatogenous retinal detachment and to evaluate the differences in outcome between patients suffering macula-off retinal detachment and those without a macular involvement. METHODS: As a retrospective interventional case series, Munster Study on Therapy Achievements in Retinal Detachment (MUSTARD) is one of the largest ever established of retinal detachment patients and their outcome after buckling surgery, with 4325 patients who underwent surgery between 1980 and 2001. In 53.94% (n = 2134) of 3956 patients with nontraumatic retinal detachment, the macula was involved. The main outcome measure was the achievement of dry anatomical attachment of the retina. RESULTS: The success rate in patients with macula-off retinal detachment is 80.46% and thus 7.78% lower (p < 0.01) than that in those patients with their macula intact whose success rate amounted to 88.24%. The overall success rate of all 4325 MUSTARD patients was 83.98%. CONCLUSIONS: Scleral buckling is an established and mostly successful method for the treatment of retinal detachment. As our case series has demonstrated, even eyes with macula-off can be treated successfully by this procedure, thereby avoiding the complications of primary vitrectomy.

Reconstruction of a Bryan and Morrey type I capitellar fracture in a sawbone model with four different fixation devices: an experimental study.

BACKGROUND: We evaluated 4 different fixation devices for the reconstruction of a standardised Bryan and Morrey capitellar shear fracture in a sawbone model. Outcome measurements were the quality of reduction, time for reconstruction and stability. METHODS: 80 standardised Bryan and Morrey type I fractures were created for 5 different orthopaedic surgeons in 80 sawbones. Each surgeon reconstructed 16 fractures with 2mm K-wires, 3mm Herbert screws, 2.7 mm AO screws and 2.2mm fine-threaded wires (Fragment Fixation System: FFS). 4 fractures were allocated to each method with a standardised reconstruction procedure. Quality of reduction and time for reconstruction were measured after definitive fixation. Biomechanical testing was performed using a shear loading model with the application of monocyclic or polycyclic stress to the reconstructed capitulum. RESULTS: There was no difference in the quality of reduction with the different fixation devices. Herbert and AO screw fixation was slower than the other implants (p<0.05). No difference in the time for reconstruction was observed with K-wires and FFS. Failure load was less for K-wires compared to FFS, Herbert screws and AO screws (p<0.05). With polycyclic loading, residual deformation was higher with K-wire reconstruction compared to FFS, Herbert screws and AO screws (p<0.05). CONCLUSION: When using four different fixation devices, the fixation of standardised Bryan and Morrey type I fractures in the sawbone model differs when it comes to the time needed for reduction, but not in the quality of reduction. Stability was the same for the implants used, except for the K-wires. There is no argument in favour one of the screw implants over another in clinical use.

Multicenter, prospective, open-label, observational study of bimatoprost 0.01% in patients with primary open-angle glaucoma or ocular hypertension.

BACKGROUND: Bimatoprost 0.01% was developed for improved tolerability over bimatoprost 0.03%, while maintaining efficacy in lowering intraocular pressure (IOP). This multicenter, prospective, open-label, observational study was designed to investigate the efficacy and tolerability of bimatoprost 0.01% in routine clinical practice. METHODS: Data were collected from 10,337 patients with primary open-angle glaucoma or ocular hypertension attending 1334 centers in Germany. The primary efficacy outcome was mean change in IOP in each eye from baseline to 10-14 weeks after initiation of bimatoprost 0.01%. Target IOP, prior therapies, additional treatments, and adverse events were also assessed. All treatment decisions were at the physicians' discretion. RESULTS: Bimatoprost 0.01% significantly lowered mean IOP from baseline by -4.1 mmHg (P < 0.0001) in all patients after a mean of 10.45 weeks. In patients without previous treatment, bimatoprost 0.01% reduced mean IOP from baseline by -6.5 mmHg (P < 0.0001). Bimatoprost 0.01% also significantly reduced IOP in patients previously treated with monotherapy of ß-blockers, prostaglandin analogs, carbonic anhydrase inhibitors or bimatoprost 0.03%. No adverse events were reported by 93.9% of patients during treatment with bimatoprost 0.01%; the most commonly reported adverse events were eye irritation (2.0%), ocular hyperemia (1.4%), and conjunctival hyperemia (1.2%). Physicians and patients rated tolerability and adherence as high, and most patients said they would continue with bimatoprost 0.01% treatment. CONCLUSION: Bimatoprost 0.01% can produce additional IOP-lowering effects when used in routine clinical practice in patients who have received prior therapy, in addition to lowering IOP in previously untreated patients. A high rate of continuation of therapy with bimatoprost 0.01% was observed in patients who switched from a variety of different medications. The results suggest that bimatoprost 0.01% is a suitable first-choice therapy in patients with primary open-angle glaucoma or ocular hypertension.

Long-term outcomes of prostaglandin analog versus timolol maleate in ocular hypertensive or primary open-angle glaucoma patients in Europe.

PURPOSE: To determine the direct costs of therapy over 5 years of a European monotherapy cohort begun on a prostaglandin (PTG) versus timolol in patients with primary open-angle glaucoma or ocular hypertension. METHODS: A retrospective, multicenter, active-controlled, observational study. Data were abstracted for European patients treated as initial monotherapy in 1996 or afterward, with 5 years of available records. RESULTS: This study included 271 patients (166 on a PTG and 105 on timolol at baseline). The average cost/month/patient over 5 years was $45.47±12.61 for PTG and $31.50±15.47 for timolol (P<0.001, based on German prices). After 5 years, although there was no difference in number of glaucoma medicines prescribed between groups (1.0 PTGs and 1.1 timolol, P=0.41), the timolol group demonstrated a higher intraocular pressure (17.7±2.9 vs. 16.5±3.0 mm Hg, P<0.001), more medication changes (P=0.01), greater incidence of glaucomatous progression (P=0.04), and less patients persistent on original monotherapy (P<0.001) than the PTG cohort. CONCLUSIONS: Patients originally on timolol monotherapy have a lower cost of care over 5 years than those started on a PTG. However, timolol patients during follow-up may demonstrate a higher intraocular pressure, more progression, more medication changes, and lower persistency of the original monotherapy.

International vision requirements for driver licensing and disability pensions: using a milestone approach in characterization of progressive eye disease.

OBJECTIVE: Low vision that causes forfeiture of driver's licenses and collection of disability pension benefits can lead to negative psychosocial and economic consequences. The purpose of this study was to review the requirements for holding a driver's license and rules for obtaining a disability pension due to low vision. Results highlight the possibility of using a milestone approach to describe progressive eye disease. METHODS: Government and research reports, websites, and journal articles were evaluated to review rules and requirements in Germany, Spain, Italy, France, the UK, and the US. RESULTS: Visual acuity limits are present in all driver's license regulations. In most countries, the visual acuity limit is 0.5. Visual field limits are included in some driver's license regulations. In Europe, binocular visual field requirements typically follow the European Union standard of ≥120°. In the US, the visual field requirements are typically between 110° and 140°. Some countries distinguish between being partially sighted and blind in the definition of legal blindness, and in others there is only one limit. CONCLUSIONS: Loss of driving privileges could be used as a milestone to monitor progressive eye disease. Forfeiture could be standardized as a best-corrected visual acuity of <0.5 or visual field of <120°, which is consistent in most countries. However, requirements to receive disability pensions were too variable to standardize as milestones in progressive eye disease. Implementation of the World Health Organization criteria for low vision and blindness would help to establish better comparability between countries.

Treatment of patients with primary open-angle glaucoma with a fixed combination of brimonidine 0.2%/timolol 0.5%: multicenter, open-label, observational study in Germany.

OBJECTIVE: At the introduction of the fixed-combination of brimonidine/timolol in Germany in 2006, a non-interventional, multicenter, observational, open-label study was initiated to evaluate efficacy, tolerability, and safety of this preparation in a broad patient population. METHODS: The study population comprised patients with bilateral primary open-angle glaucoma or ocular hypertension with insufficient intraocular pressure (IOP) control who participating physicians determined required a change of medication, and who switched to exclusive use of the new fixed-combination brimonidine 0.2%/timolol 0.5%. Patient demographics and information on specific risk factors were collected. IOP readings were recorded for each eye at treated baseline (previous therapy), 4 to 6 weeks, and 12 weeks after changing to twice-daily brimonidine/timolol. Tolerability was measured using a four-step scale ranging from excellent to poor. All adverse events were recorded. RESULTS: Mean treated baseline IOP (+/-SD) for all patients (N = 861) was 20.8 +/- 3.5 mmHg. Five hundred sixty-five patients switched from monotherapy, 138 patients switched from other fixed combinations, and 158 patients had been using non-fixed combinations of up to four different active agents. The brimonidine/timolol fixed combination provided an additional IOP decrease in most pretreatment subgroups, with an overall reduction to 16.9 +/- 2.6 mmHg after 4 to 6 weeks and to 16.5 +/- 2.7 mmHg after 12 weeks. Both of these values were significantly lower than baseline IOP (p < 0.001). A target pressure of <18 mmHg was achieved in 79.5% of all eyes at week 12. Tolerability of fixed-combination brimonidine/timolol was rated excellent or good by the physicians for 97.1% of patients, and by 93.4% of the patients themselves. Few adverse events occurred during the treatment period. CONCLUSIONS: Although this study was limited by its observational design, our results show that the fixed combination of brimonidine 0.2%/timolol 0.5% was effective, well tolerated, and safe in a broad POAG patient population.

Treatment of glaucoma patients with insufficient intraocular pressure control: a survey of German ophthalmologists in private practice.

OBJECTIVE: To assess the degree to which glaucoma treatment guidelines have been incorporated into daily practices and to describe the therapeutic practices chosen for patients with insufficient intraocular pressure (IOP) control. METHODS: Ophthalmologists in private practice in Germany were surveyed to obtain information about patients who exhibited unsatisfactory progress with IOP-lowering pharmacotherapy. Using a questionnaire, physicians provided data concerning treatment difficulty, target IOP, number and type of medications used, two most recent IOP readings, and optic nerve head and visual field observations. RESULTS: Of the 853 patients analyzed, primary open-angle glaucoma was the diagnosis for 67.1%, and other diagnoses included ocular hypertension, normal tension glaucoma, and pseudoexfoliation glaucoma. Target IOP levels had been determined for 95.5% of patients, and not achieving the target pressure was identified as a treatment difficulty for 81.0% of patients. Of patients on monotherapy, beta-blockers were prescribed most often (42.3%). Of all patients, 53.3% were treated with two or more agents as either fixed or non-fixed combinations. The non-fixed combination of a prostaglandin and carbonic anhydrase inhibitor was the most frequently prescribed dual therapy (19.2%). Non-fixed prostaglandin plus beta-blocker was used by 18.0% of dual therapy patients, whereas the available fixed combination was used by 10.5%. Non-compliance was identified as a cause of unsatisfactory IOP-lowering in 26.8% of all patients. This study is limited by its descriptive, non-interventional design. CONCLUSIONS: Treatment alterations are necessary to achieve sufficient IOP control in some patients. If these patients were to take advantage of more aggressive therapies as outlined by treatment guidelines, including newer formulations and fixed combination preparations, both efficacy and compliance may be improved.