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.

Atomic force microscopy of microvillous cell surface dynamics at fixed and living alveolar type II cells.

Scanning probe techniques enable direct imaging of morphology changes associated with cellular processes at life specimen. Here, glutaraldehyde-fixed and living alveolar type II (ATII) cells were investigated by atomic force microscopy (AFM), and the obtained topographical data were correlated with results obtained by scanning electron microscopy (SEM) and confocal microscopy (CM). We show that low-force contact mode AFM at glutaraldehyde-fixed cells provides complementary results to SEM and CM. Both AFM and SEM images reveal fine structures at the surface of fixed cells, which indicate microvilli protrusions. If ATII cells were treated with Ca(2+) channel modulators known to induce massive endocytosis, changes of the cell surface topography became evident by the depletion of microvilli. Low force contact mode AFM imaging at fixed ATII cells revealed a significant reduction of the surface roughness for capsazepine and 2-aminoethoxydiphenyl-borate (CPZ/2-APB)-treated cells compared to untreated control cells (Rc of 99.7 ± 6.8 nm vs. Rc of 71.9 ± 4.6 nm for N = 22), which was confirmed via SEM studies. CM of microvilli marker protein Ezrin revealed a cytoplasmic localization of Ezrin in CPZ/2-APB-treated cells, whereas a submembranous Ezrin localization was observed in control cells. Furthermore, in situ AFM investigations at living ATII cells using low force contact mode imaging revealed an apparent decrease in cell height of 17% during stimulation experiments. We conclude that a dynamic reorganization of the microvillous cell surface occurs in ATII cells at conditions of stimulated endocytosis.

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.

Plasma membrane trafficking in alveolar type II cells.

Alveolar type II (ATII) cells produce surfactant and release it into the alveolar space via exocytosis of lamellar bodies (LBs). On the other hand, various forms of endocytosis take place, enabling the recycling of surfactant as well as of integral membrane proteins to the LB. Here we investigated the trafficking of protein and lipid components of plasma membrane between the plasma and limiting LB membrane by over-expressing lysosomal associated membrane protein 3 fused to green fluorescence protein (LAMP-3-GFP) and farnesylated DsRed (DsRed-Farn). LAMP-3-GFP was homogenously distributed over the entire limiting LB membrane, whereas DsRed-Farn predominantly accumulated at the plasma membrane. However, in a minor LB fraction, DsRed-Farn was also found in discrete domains at its limiting membrane. Upon stimulation of ATII cells with secretagogues, the area of DsRed-Farn domains on LB surfaces increased 2 to 4 fold within 20 minutes of stimulation. This increase remained unaffected by phenylarsine oxide, an inhibitor of clathrin-dependent endocytosis, but was almost abolished by filipin and indomethacin, blockers of clathrin-independent endocytosis. It was also blocked by bafilomycin A1, wortmannin and LY294002, inhibitors of intra-cellular vesicular transport. We conclude that secretagogues facilitate the transport of plasma membrane components to LBs via a clathrin-independent vesicular transport pathway.

2-APB and capsazepine-induced Ca2+ influx stimulates clathrin-dependent endocytosis in alveolar epithelial cells.

Calcium as a second messenger influences many cellular and physiological processes. In lung, alveolar type II (ATII) cells sense mechanical stress and respond by Ca(2+) dependent release of surfactant, which is essential for respiratory function. Nevertheless, Ca(2+) signaling mechanisms in these cells--in particular Ca(2+) entry pathways are still poorly understood. Herein, we investigated pharmacological properties of non-voltage-gated Ca(2+) channel modulators in ATII and NCI-H441 cells and demonstrate that 2-Aminoethoxydiphenyl-borinate (2-APB) and capsazepine (CPZ) activate Ca(2+) entry with pharmacologically distinguishable components. Surprisingly, 2-APB and CPZ activated clathrin dependent endocytosis in ATII and NCI-H441 cells, which was dependent on Ca(2+) entry. The internalized material accumulated in non-acidic granules distinct from surfactant containing lamellar bodies (LB). LB exocytosis was not observed under these conditions. Our study demonstrates that 2-APB/CPZ induces Ca(2+) entry which unlike ATP- or stretch-induced Ca(2+) entry in ATII cells does not activate exocytosis but an opposing endocytotic mechanism.

Existence of exocytotic hemifusion intermediates with a lifetime of up to seconds in type II pneumocytes.

Exocytosis proceeds through prefusion stages such as hemifusion, but hemifusion is still an elusive intermediate of unknown duration. Using darkfield and fluorescence microscopy in ATII (alveolar type II) cells containing large secretory vesicles (LBs; lamellar bodies), we show that exocytotic fusion events were accompanied by a mostly biphasic SLID (scattered light intensity decrease) originating from the vesicle border. Correlation with the diffusional behaviour of fluorescence markers for either content or membrane mixing revealed that the onset of the fast second phase of SLID corresponded to fusion pore formation, which was followed by vesicle swelling. In contrast, a slow first phase of SLID preceded pore formation considerably but could still be accompanied by diffusion of farnesylated DsRed, an inner plasma membrane leaflet marker, or Nile Red. We conclude that hemifusion is an exocytotic intermediate that may last for several seconds. SLID is a new, non-invasive approach by which a prefusion phase, including hemifusion, can be continuously recorded and distinguished from fusion pore formation and postfusion vesicle swelling.

Limited predictive value of FDG-PET for response assessment in the preoperative treatment of esophageal cancer: results of a prospective multi-center trial (SAKK 75/02).

BACKGROUND: Only responding patients benefit from preoperative therapy for locally advanced esophageal carcinoma. Early detection of non-responders may avoid futile treatment and delayed surgery. PATIENTS AND METHODS: In a multi-center phase ll trial, patients with resectable, locally advanced esophageal carcinoma were treated with 2 cycles of induction chemotherapy followed by chemoradiotherapy (CRT) and surgery. Positron emission tomography with 2[fluorine-18]fluoro-2-deoxy-d-glucose (FDG-PET) was performed at baseline and after induction chemotherapy. The metabolic response was correlated with tumor regression grade (TRG). A decrease in FDG tumor uptake of less than 40% was prospectively hypothesized as a predictor for histopathological non-response (TRG > 2) after CRT. RESULTS: 45 patients were included. The median decrease in FDG tumor uptake after chemotherapy correlated well with TRG after completion of CRT (p = 0.021). For an individual patient, less than 40% decrease in FDG tumor uptake after induction chemotherapy predicted histopathological non-response after completion of CRT, with a sensitivity of 68% and a specificity of 52% (positive predictive value 58%, negative predictive value 63%). CONCLUSIONS: Metabolic response correlated with histopathology after preoperative therapy. However, FDG-PET did not predict non-response after induction chemotherapy with sufficient clinical accuracy to justify withdrawal of subsequent CRT and selection of patients to proceed directly to surgery.

Axillary Surgery in Breast Cancer Patients Treated with Breast-Conserving Surgery at German Breast Cancer Centers Within the Last 14 Years - Comparison of a University Center and a Community Hospital.

Background Guideline recommendations for axillary surgical approach in breast cancer (BC) treatment changed over the last decade. Methods Data from all invasive BC patients (n = 5344) treated with breast conserving surgery (BCS) at the breast cancer centers of the University Hospital Ulm (U-BCC) and the community hospital Dachau (D-BCC) were included into a retrospective analysis for assessing information on axillary surgery between 2003 and 2016 based on the documented cancer registry data. Results The average annual rate of sentinel node biopsy (SNB) was 85.5% and 87.2% in Ulm and Dachau, respectively. SNB was performed more precisely at the U-BCC with a median of 2.4 resected lymph nodes (LN) compared to a median of 3.2 resected LN in Dachau. Median number of resected LN for axillary lymph node dissection (ALNE) showed a statistically significant reduction over time in Ulm (r s = - 0.82; p < 0.001) and Dachau (r s = - 0.76; p = 0.002). The rate of secondary ALNE (after SNB; 2° ALNE) decreased significantly in U-BCC (r s = - 0.76; p = 0.002) while it remained stable in D-BCC. The influential publication of the Z0011 study in 2010 resulted in a significant reduction of secondary ALNE (24.1% preZ0011 and 14.4% postZ0011; p < 0.001) in Ulm. Conclusion Changes in axillary surgery over time can be seen in the annual statistics of the reviewed BCCs. With BCS, mostly SNB was performed and numbers of removed LN in ALNE have decreased. In the U-BCC, the rate of 2° ALNE dropped after the publication of the Z0011 data. The fact that no such decrease for 2° ALNE was found in D-BCC suggests that university hospitals implement new data and research results into clinical routine earlier than peripheral community hospitals.

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.

Benefit to patients of bilateral same-day cataract extraction: Randomized clinical study.

PURPOSE: To compare patients' self-assessed visual function after bilateral surgery performed on the same day with visual function after surgery in 1 eye at a time. SETTING: Department of Ophthalmology, Blekinge Hospital, Karlskrona, Sweden. METHODS: Patients with bilateral cataract were assigned randomly to 2 groups, patients having bilateral surgery on the same day and patients with 2 surgeries done 2 months apart. Both groups were examined before and 2 months and 4 months after surgery. All patients completed the Catquest questionnaire at each ophthalmic examination. RESULTS: Until both eyes were operated on, patients having surgery in 1 eye had significantly more difficulties performing daily life activities (P<.001) and a worse binocular contrast sensitivity (P<.01) than patients who had bilateral surgery on the same day. Four months after surgery of both eyes in both groups, there was no difference in visual function. CONCLUSIONS: Bilateral cataract surgery on the same day allowed rapid rehabilitation of the patient and helped avoid suboptimal visual function in daily life while waiting for second-eye surgery. However, there was no extra long-term benefit of self-assessed visual function compared with cataract surgery in 1 eye at a time.

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.

Plasma testosterone and sexual function in men receiving buprenorphine maintenance for opioid dependence.

High-dose methadone is well known to cause testosterone deficiency and sexual dysfunction in opioid-dependent men. Buprenorphine is a new drug for the pharmacotherapy of opioid dependence. Its influence on the gonadal axis has not been investigated to date. We therefore assayed testosterone, free testosterone, estradiol, SHBG, LH, FSH, and prolactin in 17 men treated with buprenorphine. Thirty-seven men treated with high-dose methadone and 51 healthy blood donors served as controls. Sexual function and depression were assessed using a self-rating sexual function questionnaire and the Beck Depression Inventory. Patients treated with buprenorphine had a significantly higher testosterone level [5.1 +/- 1.2 ng/ml (17.7 +/- 4.2 nmol/liter) vs. 2.8 +/- 1.2 ng/ml (9.7 +/- 4.2 nmol/liter); P < 0.0001] and a significantly lower frequency of sexual dysfunction (P < 0.0001) compared with patients treated with methadone. The testosterone level of buprenorphine-treated patients did not differ from that of healthy controls. In conclusion, we demonstrated for the first time that buprenorphine, in contrast with high-dose methadone, seems not to suppress plasma testosterone in heroin-addicted men. To this effect, buprenorphine was less frequently related to sexual side effects. Buprenorphine might therefore be favored in the treatment of opioid dependence to prevent patients from the clinical consequences of methadone-induced hypogonadism.

Previous cataract surgery in a defined Swedish population.

PURPOSE: To study the prevalence of previous cataract surgery (PCS) in different age groups in a defined Swedish population. SETTING: Department of Ophthalmology, Blekinge Hospital, Karlskrona, Sweden. METHODS: This investigation of the population of Blekinge County, Sweden, was performed in June 2001. All previous cataract extractions in the district were performed at a single surgical unit, and the register of this unit contains data on all consecutive operations since 1980. The population register in the district was studied to ascertain the number of female and male individuals in different age groups for each year from 1980 though 2000. Included were data about deceased patients and those who moved from the area. RESULTS: During 21 calendar years, 10,538 patients had cataract surgery; 6,697 of them (63.6%) were alive in June 2001. The survival rate for patients having cataract surgery during the period shows a linear curve for patients operated on during the past 13 years. Among those in the district aged 70 or older, 23.9% of women and 14.0% of men had cataract extraction in 1 or both eyes. In the population aged 40 years and older, 6.43% had a history of PCS. The annual surgery volume is increasing because of a backlog of cataract cases and because of the yearly incidence. With an increase in the annual surgery volume, it is estimated that given the present indications for surgery, it will take 5 to 10 years to reach a level that means further surgery only in patients having new cataract. CONCLUSION: Even though there is already a much higher prevalence of PCS than is known from the literature, the annual surgery volume continues to increase, even in older age groups.

Indication criteria for cataract extraction and gender differences in waiting time.

PURPOSE: The purpose of this study was to investigate national indication criteria tool for cataract extraction (NIKE), a clinical tool for establishing levels of indications for cataract surgery, in relation to gender differences in waiting times for cataract extraction (CE). METHODS: Data were collected by The Swedish National Cataract Register (NCR). Eye clinics report to NCR voluntarily and on regular basis (98% coverage). Comparisons regarding gender difference in waiting times were performed between NIKE-categorized and non-NIKE-categorized patients, as well as between different indication groups within the NIKE-system. All calculations were performed in spss version 20. Multivariate analyses were carried out using logistic regression, and single variable analyses were carried out by Student's t-test or chi square as appropriate. RESULTS: Gender, age, visual acuity and NIKE-categorization were associated with waiting time. Female patients had a longer waiting time to CE than male, both within and outside the NIKE-system. Gender difference in waiting time was somewhat larger among patients who had not been categorized by NIKE. In the non-NIKE-categorized group, women waited 0.20 months longer than men. In the group which was NIKE-categorized, women waited 0.18 months longer than men. CONCLUSIONS: It is reasonable to assume that prioritizing patients by means of NIKE helps to reduce the gender differences in waiting time. Gender differences in waiting time have decreased as NIKE was introduced and there may be a variety of explanations for this. However, with the chosen study design, we could not distinguish between effects related to NIKE and those due to other factors which occurred during the study period.

Immediate versus delayed sequential bilateral cataract surgery: an analysis of costs and patient value.

PURPOSE: To compare resource utilization of two different strategies for bilateral cataract surgery: immediate sequential cataract surgery (ISCS) versus delayed sequential cataract surgery (DSCS). The purpose was also to analyse the value for the patient of undergoing ISCS versus DSCS. METHODS: Differences in routines and resource utilization between ISCS (n = 17) and DSCS (n = 80) were studied in a cohort of cataract surgery patients at our clinic in Karlskrona, Sweden. Costs were extracted from an earlier publication by the same clinic. The value for the patient was studied using the capability index, based on published data on the benefit to the patient of ISCS or DSCS using the Catquest questionnaire. RESULTS: Operating both eyes of a patient was 1.14 times more expensive with DSCS than with ISCS including all surgical costs. The value to the patient of undergoing ISCS depended on the time between first- and second-eye surgery in DSCS and the remaining lifetime after both-eye surgery. A long waiting time for second-eye surgery and a short remaining lifetime decreased the patient value of DSCS compared to ISCS. CONCLUSION: DSCS is 14% more expensive than ISCS. The value for the patient of ISCS compared to DSCS depends on how long the period will be between first- and second-eye surgery in DSCS and also on the patient's survival time after surgery.

(11)C-acetate PET in the early evaluation of prostate cancer recurrence.

PURPOSE: The first aim of the study was to investigate the diagnostic potential of (11)C-acetate PET in the early detection of prostate cancer recurrence. A second aim was the evaluation of early and late PET in this context. METHODS: The study population comprised 32 prostate cancer patients with early evidence of relapse after initial radiotherapy (group A) or radical surgery (group B). The median PSA of group A (n=17) patients was 6 ng/ml (range 2.6-30.2) while that of group B (n=15) was 0.4 ng/ml (range 0.08-4.8). Pelvic-abdominal-thoracic PET was started 2 min after injection of (11)C-acetate and evaluated after fusion with CT. RESULTS: Group A: Taking a SUV(max)> or =2 as the cut-off, PET showed local recurrences in 14/17 patients and two equivocal results. Distant disease was observed in six patients and an equivocal result was obtained in one. Endorectal MRI was positive in 12/12 patients. Biopsy confirmed local recurrence in six of six (100%) patients. PET was positive in five of the six patients with biopsy-proven recurrences, the result in the remaining patient being equivocal. Group B: Among the 15 patients, visual interpretation was positive for local recurrences in five patients and equivocal in four. One obturator lymph node was positive. Endorectal MRI was positive in 11/15 patients and equivocal in two. Positional correlation of positive/equivocal results on PET and endorectal MRI was observed in seven of nine patients. PSA decreased significantly after salvage radiotherapy in 8/14 patients, providing strong evidence for local recurrence. PET of the eight patients responding to RT was positive in three and equivocal in two. CONCLUSION: (11)C-acetate PET was found to be valuable in the early evaluation of prostate cancer relapse. Optimising scanning time and use of modern PET-CT equipment might allow further improvement.

18F-choline and/or 11C-acetate positron emission tomography: detection of residual or progressive subclinical disease at very low prostate-specific antigen values (<1 ng/mL) after radical prostatectomy.

OBJECTIVES: To assess the value of positron emission tomography (PET)/computed tomography (CT) with either (18)F-choline and/or (11)C-acetate, of residual or recurrent tumour after radical prostatectomy (RP) in patients with a prostate-specific antigen (PSA) level of <1 ng/mL and referred for adjuvant or salvage radiotherapy. PATIENTS AND METHODS: In all, 22 PET/CT studies were performed, 11 with (18)F-choline (group A) and 11 with (11)C-acetate (group B), in 20 consecutive patients (two undergoing PET/CT scans with both tracers). The median (range) PSA level before PET/CT was 0.33 (0.08-0.76) ng/mL. Endorectal-coil magnetic resonance imaging (MRI) was used in 18 patients. Nineteen patients were eligible for evaluation of biochemical response after salvage radiotherapy. RESULTS: There was abnormal local tracer uptake in five and six patients in group A and B, respectively. Except for a single positive obturator lymph node, there was no other site of metastasis. In the two patients evaluated with both tracers there was no pathological uptake. Endorectal MRI was locally positive in 15 of 18 patients; 12 of 19 responded with a marked decrease in PSA level (half or more from baseline) 6 months after salvage radiotherapy. CONCLUSIONS: Although (18)F-choline and (11)C-acetate PET/CT studies succeeded in detecting local residual or recurrent disease in about half the patients with PSA levels of <1 ng/mL after RP, these studies cannot yet be recommended as a standard diagnostic tool for early relapse or suspicion of subclinical minimally persistent disease after surgery. Endorectal MRI might be more helpful, especially in patients with a low likelihood of distant metastases. Nevertheless, further research with (18)F-choline and/or (11)C-acetate PET with optimal spatial resolution might be needed for patients with a high risk of distant relapse after RP even at low PSA values.

NIKE: a new clinical tool for establishing levels of indications for cataract surgery.

PURPOSE: The purpose of this study was to construct a new clinical tool for establishing levels of indications for cataract surgery, and to validate this tool. METHODS: Teams from nine eye clinics reached an agreement about the need to develop a clinical tool for setting levels of indications for cataract surgery and about the items that should be included in the tool. The tool was to be called 'NIKE' (Nationell Indikationsmodell för Kataraktextraktion). The Canadian Cataract Priority Criteria Tool served as a model for the NIKE tool, which was modified for Swedish conditions. Items included in the tool were visual acuity of both eyes, patients' perceived difficulties in day-to-day life, cataract symptoms, the ability to live independently, and medical/ophthalmic reasons for surgery. The tool was validated and tested in 343 cataract surgery patients. Validity, stability and reliability were tested and the outcome of surgery was studied in relation to the indication setting. RESULTS: Four indication groups (IGs) were suggested. The group with the greatest indications for surgery was named group 1 and that with the lowest, group 4. Validity was proved to be good. Surgery had the greatest impact on the group with the highest indications for surgery. Test-retest reliability test and interexaminer tests of indication settings showed statistically significant intraclass correlations (intraclass correlation coefficients [ICCs] 0.526 and 0.923, respectively). CONCLUSIONS: A new clinical tool for indication setting in cataract surgery is presented. This tool, the NIKE, takes into account both visual acuity and the patient's perceived problems in day-to-day life because of cataract. The tool seems to be stable and reliable and neutral towards different examiners.