What about the fellow eye in treatment of neovascular age-related macular degeneration? Analysis of data from the Swedish macula register.

PURPOSE: To analyse the development of neovascular age-related macular degeneration (nAMD) in the fellow eye in patients initially presenting with unilateral nAMD, using data from the Swedish Macula Register. METHODS: This observational study included data on treatment-naïve patients who initially underwent unilateral treatment for nAMD, and then required bilateral treatment, between 2010 and 2018, according to the Swedish Macula Register (SMR). The data were also stratified according into three time periods (2010-2013; 2014-2016; 2017-2018). Treatment duration, best-corrected visual acuity (BCVA) in the first and second eye, number of injections in the first eye before falling ill in the second, and the time between the last injection in the first eye and the start of treatment of the fellow eye were analysed. RESULTS: 5216 out of 28 670 (18%) patients treated for nAMD subsequently required bilateral treatment. The mean age was 77.7 ± 7.3 years, and 69% were female. The mean duration of treatment of the first eye before nAMD was diagnosed in the fellow eye was 1.58 years, and the mean number of injections in the first eye was 8.9 ± 8.6. Best-corrected visual acuity, according to the ETDRS chart, was higher in the second eye at the time when treatment started in that eye compared to treatment start in the first eye: 62.8 (14.7) versus 57.6 (15.5); p < 0.001, and was higher in the 66% whose first eye was still undergoing treatment: 63.6 ± 14.5 versus 61.0 ± 14.8; p = 0.001. CONCLUSIONS: The mean duration of treatment of the first eye before treatment started in the fellow eye was 19 months, and treatment of the second eye had started within 2 years in 61% of the patients. Best-corrected visual acuity was higher in the second eye than in the first eye at the start of treatment of that eye and was higher in the second eye at the start of treatment of that eye when the first eye was still being treated.

Exploration of real-world outcomes and treatment patterns in patients treated with anti-vascular endothelial growth factors for neovascular age-related macular degeneration in Sweden.

PURPOSE: To analyse and compare the number and interval of anti-vascular endothelial growth factor (anti-VEGF) injections in neovascular age-related macular degeneration (nAMD), as well as the visual development in patients followed up for one to three years in clinical practice and during different index periods. METHODS: This observational study included treatment-naïve eyes with nAMD from the Swedish Macula Register that started treatment between 2007 and 2017, stratified by different index periods (2007-2010, 2011-2013, 2014-2015 and 2016-2017) and by follow-up cohorts for each index period of one, two or three years (cohorts 1-3). Their intravitreal anti-VEGF treatment was assessed by number of injections, injection intervals, visual acuity (VA) and near VA change. RESULTS: From the earliest index period 2007-2010 to the latest 2016-2017, the number of injections increased for the comparable follow-up time; 6.2 ± 1.4 versus 8.3 ± 2.0 injections after 1 year of treatment, 4.8 ± 1.6 versus 6.7 ± 2.4 during year 2. The last injection interval was 73 ± 34 days after 1, 71 ± 33 after 2 and 67 ± 32 after 3 years of follow-up for the index period 2014-2015. For the same period, the percentage of eyes with at least two consecutive 12-16 weeks of injection interval over 1-, 2- and 3-year follow-up increased from 5.2%, 15.0%, to 17.5% respectively. Baseline VA for eyes indexed 2016-2017 increased and presented with 62.1 ± 13.4 letters compared with 57.7 ± 13.5 letters in 2007-2010; p < 0.0001. CONCLUSIONS: From the earliest to the latest index periods, the number of injections increased for the comparable follow-up time. Accordingly, baseline VA and near VA and their outcomes improved continuously.

Treatment of age-related macular degeneration after cataract surgery: a study from the Swedish National Cataract and Macula Registers.

PURPOSE: To characterize pre- and perioperative factors associated with treatment for wet age-related macular degeneration (wet AMD) after cataract surgery. METHODS: This register-based cohort study with data from the Swedish National Cataract Register (NCR) and the Swedish Macula Register (SMR) from 2010 to 2017 compared eyes with and without preoperative AMD that had undergone cataract surgery and was subsequently treated for wet AMD to eyes not treated within the study period. All first-eye surgeries registered in the NCR from 2010 to 2017 and matching eyes found in the SMR that had undergone treatment for wet AMD ≥ 1 year after the cataract procedure were included. Data for cataract surgery date, age and gender, use of a blue-blocking IOL, preoperative visual acuity, ocular comorbidities, posterior capsule rupture and date of AMD treatment initiation were extracted. RESULTS: The only independent factor associated with postoperative treatment of wet AMD in both groups was female gender (67.3% vs. 58.8%, p < 0.001 and 66.4% vs. 60.6%, p = 0.001, respectively). Older age was an independent factor in eyes without preoperative AMD (78.4 ± 6.5 vs. 73.4 ± 9.6 years, p < 0.001). A blue-blocking IOL appeared to decrease the likelihood of subsequent wet AMD treatment slightly but not statistically significant in eyes with preoperative AMD (52.7% vs. 56.8%, p = 0.110). CONCLUSIONS: Some factors (female gender, high age) are associated with undergoing subsequent treatment for wet AMD to a higher extent. If the use of a blue-blocking IOL offers any protection from undergoing AMD treatment after cataract surgery, such an effect must be very small.

Follow-Up After Cataract Surgery - Comparison of the Practice in Two Institutions with the Aim of Optimize the Routine.

PURPOSE: To evaluate the number of postoperative visits after cataract surgery in two institutions with different routines. PATIENTS AND METHODS: A population-based prospective, observational, cohort study was conducted at two institutions in northern Sweden. All cataract surgery cases during a 1-year period were included. The study group was 1249 cases, who followed the standard routine at the Sunderby clinic, ie, no planned postoperative visit for patients without comorbidity who had uncomplicated surgery. All cases (n=1162) having surgery during the same 1-year period at the Umeå clinic were selected as the control group. The routine in Umeå was a planned postoperative visit for all patients after first eye surgery, and on second eye surgery patients with other ocular comorbidity. RESULTS: A postoperative visit was planned in 44% (555/1249) of the study group and in 83% of all control group cases (966/1162). Significantly less patients in the study group (9% vs 16%; p=0.000036) initiated an unplanned contact. Patients with a distance to the hospital of 70 km or longer were less inclined to seek unplanned care (p=0.016). There was no difference in postoperative outcomes between the patients who initiated contact and those who did not in the study and control hospitals. CONCLUSION: Without compromising patient safety, it is possible to reduce the burden of postoperative visits in cases with uncomplicated cataract surgery. A reduction in the number of visits is obtained only if the standard routine is no planned postoperative visits in uncomplicated cases without ocular comorbidity for both first and second eye surgery.

Twelve per cent of 6142 eyes treated for neovascular age-related macular degeneration (nAMD) presented with low visual outcome within 2 years. Analysis from the Swedish Macula Registry (SMR).

PURPOSE: To analyse characteristics from the SMR to explore the risk factors for visual acuity (VA) below ≤ 35 letters of the Early Treatment Diabetic Retinopathy Study (ETDRS) due to nAMD during a two-year follow-up. METHODS: This study evaluates 6142 treatment-naïve eyes, with focus on a subgroup of 780 eyes with final VA outcome of ≤ 35 letters, regarding differences of baseline characteristics, change of VA, number of injections and choice of drug to predict visual outcome. RESULTS: Patients with final VA ≤ 35 letters were older; p < 0.0001, and received fewer injections, 6.2 ± 3.8 vs. 8.7 ± 5.4; p < 0.00001. Only 4% of all patients with ≥ 70 letters baseline VA decreased to a final VA of ≤ 35 letters. The two groups with a final VA of ≤ 35 letters and VA > 35 letters presented the following baseline lesion locations; p = 0.001; 61% vs. 57% subfoveal, 18% vs. 21% juxtafoveal and 4% vs. 6% extrafoveal. Lesion size, in the group with final VA ≤ 35 letters, was 2805 ± 2093 µm vs. 2440 ± 1637 µm in the group with a VA of > 35 letters; p = 0.005. A logistic regression analysis including baseline VA, best- or worse-seeing eye, age, membrane size, membrane location, symptom duration showed VA; p = < 0.0001, best- or worse-seeing eye; p = 0.026, age; p = < 0.0001, and membrane size; p = 0.002 to predict a decline of VA within 2 years. CONCLUSIONS: In eyes treated for wet AMD and studied for 2 years, 12.7% of eyes declined to a final VA of ≤ 35 letters. Visual acuity, worse-seeing eye treated, age and membrane size turned out as the baseline characteristics that had significantly influenced visual decline to ≤ 35 letters during the two-year follow-up.

Baseline visual acuity as a prognostic factor for visual outcomes in patients treated with aflibercept for wet age-related macular degeneration: data from the INSIGHT study using the Swedish Macula Register.

PURPOSE: To assess mean change in visual acuity (VA) overall and stratified by baseline VA after 1 and 2 years' treatment with aflibercept in a real-life setting. METHODS: This was an observational cohort study using nationwide data from the Swedish Macula Register. Treatment-naïve patient eyes with wet age-related macular degeneration and prescribed aflibercept from January 2013 to December 2014 were followed for 1 year (2478 eyes) or 2 years (831 eyes) to assess VA. Eyes were grouped by baseline VA. RESULTS: Mean number of injections in patients treated according to label (72%) versus patients treated not according to label was 8.0 ± 1.5 versus 4.4 ± 0.8 (p < 0.0001) at 1 year, and 12.5 ± 3.2 versus 7.3 ± 1.9 (p < 0.0001) at 2 years. Among all eyes, mean VA increased from 61.3 ± 13.4 Early Treatment Diabetic Retinopathy Study letters at baseline to 64.5 ± 15.6 at 1 year and 65.1 ± 15.1 letters at 2 years. At 2 years, eyes with good baseline vision (≥70 letters) lost a mean of 2.4 ± 11.3 to 72.3 letters, eyes with intermediate baseline VA (36-69 letters) gained 5.7 ± 14.1 to 62.7 letters, and eyes with poor baseline VA (≤35 letters) gained 13.2 ± 18.3 to 41.0 letters. Also at 2 years, 75% of treated eyes were stable or had improved VA. Among eyes with intermediate baseline VA, near vision was significantly better among those treated according to label versus not according to label at 3 (p = 0.019), 6 (p = 0.0002) and 12 months (p ≤ 0.0001). CONCLUSION: While gain in vision was especially pronounced in eyes with poor baseline VA, good baseline VA was important for best prognosis.

Risk Factors for Discontinuation of Treatment for Neovascular Age-Related Macular Degeneration.

PURPOSE: To investigate risk factors for treatment discontinuation for neovascular age-related macular degeneration (nAMD). METHODS: Data from the Swedish Macula Register and the Skåne Healthcare Register are reported on the treatment received by 932 nAMD patients diagnosed 2013-2015. Treatment discontinuation is defined as having a termination visit or lacking a control or treatment visit during the period of 10-14 months after the diagnostic visit. The risk of treatment discontinuation during the first year is estimated using a Poisson model and a classification tree. RESULTS: 503 eyes (50.9%) discontinued the treatment within the first year. Patients with visual acuity below 60 ETDRS letters (20/60 Snellen) at baseline, serious comorbidities, or treated at the university hospital have a 42% (95% CI 25-61%, P < 0.001), 27% (95% CI 13-43%, P = 0.001) and 30% (95% CI 15-46%, P < 0.001) increased risk to discontinue treatment compared with similar patients. Patients on ranibizumab therapy have a 45% (95% CI 28-63%, P < 0.001) increased risk for treatment discontinuation during year 1 compared with patients on aflibercept therapy. The classification tree also shows that patients on ranibizumab therapy and those with low VA at baseline are at a higher risk of terminating treatment. CONCLUSIONS: Almost half of the patients starting anti-VEGF therapy discontinue treatment during the first year. Patients with risk factors may require additional support to continue with the treatment. Aflibercept therapy could be an alternative to patients at risk of treatment discontinuation.

Optimizing number of postoperative visits after cataract surgery: Safety perspective.

PURPOSE: To evaluate safety perspectives when the standard routine after cataract surgery is no planned postoperative visit. SETTING: Eye Clinic, Sunderby Hospital, Luleå, Norrbotten County, Sweden. DESIGN: Prospective case series. METHODS: All cataract surgery cases during a 1-year period were included. The study group had the standard routine at the clinic, that is, no planned postoperative visit for patients without comorbidity and uneventful surgery. For the control group, patients who had surgery during 1 month of the 1-year period were chosen. All these patients had a planned postoperative visit. All surgeons involved were experienced. The outcome measures were any planned postoperative visit, any complication and/or adverse event, postoperative corrected distance visual acuity (CDVA), and any postoperative control/contact initiated by the patient. RESULTS: The study comprised 1249 patients (1115 in the study group and 134 in the control group). No significant differences in demographics, postoperative CDVA, frequency of planned visits because of ocular comorbidity, or postoperative patient-initiated contacts were found between the 2 groups. Of the 1249 patients, 9% (117 patients) initiated a postoperative contact, of whom 26% (30 patients) also had a scheduled visit. The reasons for the patient-initiated contacts were visual disturbance, redness and/or chafing, pain, and anxiety. An evaluation of all medical records 2 years postoperatively found no reports of missed adverse events. CONCLUSIONS: It was possible to refrain from planned postoperative visits for patients having uncomplicated cataract surgery. However, preoperatively, patients with comorbidities should be provided with individual planning of their postoperative follow-up. Preoperative counseling is important, and the clinic must have resources to answer questions from patients and be prepared for additional unplanned postoperative visits.

Treatment for neovascular age-related macular degeneration in Sweden: outcomes at seven years in the Swedish Macula Register.

PURPOSE: To present Swedish Macula Register (SMR) data regarding treatment of neovascular age-related macular degeneration (AMD) in clinical practice since 2008. METHODS: A retrospective register-based study was conducted. Evaluation of baseline demographics, visual outcome and number of injections during this period is presented. RESULTS: Mean age at diagnosis was 79 ± (SD) 8 years; 65% were female. The proportion of patients with <2 months' duration of symptoms increased from 26% in 2008 to 41% in 2014 (p = 0.001). Mean visual acuity (VA) at baseline increased from 54.3 ± 15.0 early treatment diabetic retinopathy study (ETDRS) letters in 2008 to 57.8 ± 15.6 letters in 2014 (CI95 2.6; 4.3; p < 0.001). Mean VA after 1 year of treatment increased from 57.8 ± 17.7 ETDRS letters for patients who started the treatment in 2008 to 62.8 ± 16.4 ETDRS letters in patients starting treatment in 2014 (CI95 2.67; 4.64; p < 0.001). During all study years, the proportion of patients with an improvement in VA of between 5 and 15 letters was around 30%, while 14% had VA improvement of more than 15 letters. The mean number of injections during the first treatment year increased from 4.3 ± 1.9 in 2008 to 5.9 ± 2.9 in 2014 (CI95 1.40; 1.67; p < 0.001). Seven-year follow-up of 322 eyes showed a mean change of -1 letters from baseline, with a mean of 21 injections for the entire period. CONCLUSION: The duration of symptoms before treatment decreased, while VA at baseline and after 1 year of treatment increased over the years and so did the number of injections. Long-term follow-up demonstrated stable VA.

RISK FOR LOW VISUAL ACUITY AFTER 1 AND 2 YEARS OF TREATMENT WITH RANIBIZUMAB OR BEVACIZUMAB FOR PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION.

PURPOSE: To investigate how patients with neovascular age-related macular degeneration treated with ranibizumab or bevacizumab respond to treatment in daily clinical practice. METHODS: Data from the Swedish Macula Register on the treatment received by 3,912 patients during 2011 to 2014 is reported. Patients' characteristics at the first visit, visual acuity, number of injections, and reason for terminating the treatment if applicable are discussed. Furthermore, the risk of having poor vision (visual acuity under 60 Early Treatment Diabetes Retinopathy Study letters or approximately 20/60 Snellen) is calculated for the treated eye after 1 year and 2 years. RESULTS: The treatment outcome depends on the visual acuity at the first visit. For patients with visual acuity more than 60 letters, the risk of having a visual acuity lower than 60 letters after 1 year or 2 years of treatment is approximately 20%. However, for patients with low visual acuity at diagnosis (fewer than 60 letters), the risk is approximately 60%. The risk of having a visual acuity lower than 60 letters does not depend on the choice of treatment drug. CONCLUSION: Treatment with anti-vascular endothelial growth factor intravitreal injections mainly maintains the visual acuity level, and only approximately 20% and 40% of the patients required vision rehabilitation after 1 year and 2 years, respectively.

Reduced occurrence of severe visual impairment after introduction of anti-Vascular Endothelial Growth Factor in wet age-related macular degeneration - a population- and register-based study from northern Sweden.

PURPOSE: To study the occurrence of severe visual impairment (SVI) and treatment outcome at 12 months in patients treated for wet age-related macular degeneration (AMD) by use of data from the Swedish Macula Register (SMR) and referrals to the regional low vision clinics in five northern counties. METHODS: Referrals to low vision clinics during 2005, 2009 and 2013 and treatment outcome at 12 months from the SMR database from 2008 until 2013 in patients >65 years of age in five northern counties were included in the survey. RESULTS: The rate of referral due to AMD was significantly reduced during the time period (-48%; p < 0.001). At 12 months, a significant slight mean improvement in logMAR visual acuity (VA) was observed (-0.01, SD 0.37; p < 0.001) after a mean of 5.0 ± 2.3 anti-vascular endothelial growth factor (VEGF)-injections were administered. Age and low baseline VA was associated with less favourable visual outcome (p < 0.001). CONCLUSION: Referral rate to low vision clinic is a valuable tool for estimating occurrence of SVI and fell between the years 2005 until 2013. Data from the SMR showed improvement in visual acuity on the whole, but also identified patients at high risk for developing SVI during anti-VEGF-treatment.

Defining a Minimum Set of Standardized Patient-centered Outcome Measures for Macular Degeneration.

PURPOSE: To define a minimum set of outcome measures for tracking, comparing, and improving macular degeneration care. DESIGN: Recommendations from a working group of international experts in macular degeneration outcomes registry development and patient advocates, facilitated by the International Consortium for Health Outcomes Measurement (ICHOM). METHODS: Modified Delphi technique, supported by structured teleconferences, followed by online surveys to drive consensus decisions. Potential outcomes were identified through literature review of outcomes collected in existing registries and reported in major clinical trials. Outcomes were refined by the working group and selected based on impact on patients, relationship to good clinical care, and feasibility of measurement in routine clinical practice. RESULTS: Standardized measurement of the following outcomes is recommended: visual functioning and quality of life (distance visual acuity, mobility and independence, emotional well-being, reading and accessing information); number of treatments; complications of treatment; and disease control. Proposed data collection sources include administrative data, clinical data during routine clinical visits, and patient-reported sources annually. Recording the following clinical characteristics is recommended to enable risk adjustment: age; sex; ethnicity; smoking status; baseline visual acuity in both eyes; type of macular degeneration; presence of geographic atrophy, subretinal fibrosis, or pigment epithelial detachment; previous macular degeneration treatment; ocular comorbidities. CONCLUSIONS: The recommended minimum outcomes and pragmatic reporting standards should enable standardized, meaningful assessments and comparisons of macular degeneration treatment outcomes. Adoption could accelerate global improvements in standardized data gathering and reporting of patient-centered outcomes. This can facilitate informed decisions by patients and health care providers, plus allow long-term monitoring of aggregate data, ultimately improving understanding of disease progression and treatment responses.

Intracameral anesthesia for cataract surgery: a population-based study on patient satisfaction and outcome.

PURPOSE: To evaluate if the standard anesthetic regimen - topical combined with intracameral anesthesia without sedation - in a population-based cohort of unselected cataract surgery cases is adequate, optimal, and good practice, or if improvements are necessary. METHODS: We conducted a prospective, observational study on all cases of cataract surgery during a 1-year period at one institution (n=1249). Data were collected from the patients' records. Outcome measures were use of preoperative sedation, type of anesthesia, complications, and adverse events. In a subgroup of patients (n=124) satisfaction with the anesthetic regimen was evaluated using a short questionnaire. RESULTS: Most cases (90%, 1125/1249) had combined topical and intracameral anesthesia without sedation. Patients who chose preoperative sedation (midazolam hydrochloride sublingually) were significantly younger and more often female (P=0.0001 and P=0.011, respectively). In the questionnaire subgroup, the median pain score after surgery was 0.7 (visual analog scale, 0-10). A pain score of 1.9 or less was reported by 76% of the patients. Patients reporting a pain score of 2 or more had sedation and additional anesthetics more often. No significant difference was found regarding age, sex, pulse rate, oxygen saturation, first or second eye surgery, or adverse intraoperative events for patients with pain scores of 1.9 or less and 2 or more. CONCLUSION: This large population-based series of small-incision phacoemulsification surgery shows that combined topical and intracameral anesthesia without sedatives is well tolerated for most phacoemulsification patients. It is also effective in cases when complications or adverse events occur. It is important to be responsive to the individual patient's needs and adjust operating procedures if necessary, as there were a few patients who experienced insufficient anesthesia.