***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: PURPOSE To evaluate the efficacy and safety of 0.18 % sodium hyaluronate ophthalmic solution ( Rejena , Vismed ) compared with its vehicle for the treatment of signs and symptoms of dry eye disease . DESIGN R and omized , placebo-controlled clinical trial . METHODS A total of 444 subjects with dry eye disease were r and omized 1:1 to active study drug ( n = 221 ) or vehicle control ( n = 223 ) in this multicenter , double-masked trial . Subjects instilled 1 to 2 drops , 3 to 6 times daily for 14 days , with evaluations at Days 7 and 14 . The study 's 2 primary efficacy endpoints were change from baseline at Day 7 in lissamine green staining scores ( objective ) and in global symptom frequency scores ( subjective ) . Results were analyzed using Wilcoxon rank sum test and Student t test in the intent-to-treat ( ITT ) population with last observation carried forward ( LOCF ) . RESULTS At Day 7 , the differences between the active and vehicle groups in change from baseline for lissamine green staining score ( P = .050 , Wilcoxon ; P = .029 , t test ) and global symptom frequency score ( P = .050 , Wilcoxon ; P = .017 , t test ) were both statistically significant . There were no clinical ly relevant safety findings related to the use of Rejena . CONCLUSIONS This study demonstrated the clinical efficacy of Rejena in the treatment of dry eye disease in both a primary objective endpoint and a primary subjective endpoint when compared to its vehicle . The study results also supported the well-known safety profile of Rejena Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials CONTEXT The relative merits of various study design s and their placement in hierarchies of evidence are often discussed . However , there is limited knowledge about the relative citation impact of articles using various study design s. OBJECTIVE To determine whether the type of study design affects the rate of citation in subsequent articles . DESIGN AND SETTING We measured the citation impact of articles using various study design s -- including meta-analyses , r and omized controlled trials , cohort studies , case-control studies , case reports , non systematic review s , and decision analysis or cost-effectiveness analysis --published in 1991 and in 2001 for a sample of 2646 articles . MAIN OUTCOME MEASURE The citation count through the end of the second year after the year of publication and the total received citations . RESULTS Meta-analyses received more citations than any other study design both in 1991 ( P<.05 for all comparisons ) and in 2001 ( P<.001 for all comparisons ) and both in the first 2 years and in the longer term . More than 10 citations in the first 2 years were received by 32.4 % of meta-analyses published in 1991 and 43.6 % of meta-analyses published in 2001 . R and omized controlled trials did not differ significantly from epidemiological studies and non systematic review articles in 1991 but clearly became the second-cited study design in 2001 . Epidemiological studies , non systematic review articles , and decision and cost-effectiveness analyses had relatively similar impact ; case reports received negligible citations . Meta-analyses were cited significantly more often than all other design s after adjusting for year of publication , high journal impact factor , and country of origin . When limited to studies addressing treatment effects , meta-analyses received more citations than r and omized trials . CONCLUSION Overall , the citation impact of various study design s is commensurate with most proposed hierarchies of evidence PURPOSE To examine the responsiveness of the National Eye Institute Visual Function Question naire-25 ( NEI VFQ-25 ) by using data from the MARINA and ANCHOR trials in neovascular age-related macular degeneration ( AMD ) and to establish the change in the NEI VFQ-25 associated with a 15-letter change in best corrected visual acuity ( BCVA ) . METHODS In MARINA , 716 patients were r and omized to monthly intravitreal ranibizumab ( 0.3 or 0.5 mg ) or sham injections . In ANCHOR , 423 patients were r and omized to monthly ranibizumab ( 0.3 or 0.5 mg ) with sham photodynamic therapy ( PDT ) or sham ocular injections with verteporfin PDT . Patients had follow-up interviews and BCVA measurements over 24 months . Data were analyzed separately for MARINA and ANCHOR , and treatment groups were pooled within each trial . The clinical ly relevant difference in NEI VFQ-25 was estimated based on regression models of change from baseline to month 12 in BCVA . RESULTS Subgroups categorized by BCVA change ( > or=15 letters gained , < 15 letters lost or gained , or > or=15 letters lost ) differed substantially in mean change in NEI VFQ-25 composite scores and three pre-specified subscale scores ( near activities , distance activities , and vision-specific dependency ) over 12 months . According to the regression models , the difference associated with a 15-letter change was 4 to 6 points for the composite score and the three pre-specified subscales . CONCLUSIONS These data support the use of the NEI VFQ-25 as a responsive and sensitive measure of vision-related function in neovascular AMD population s. Based on MARINA and ANCHOR data , a 4- to 6-point change in NEI VFQ-25 scores represents a clinical ly meaningful change corresponding to a 15-letter change in BCVA OBJECTIVE To describe grading procedures for optical coherence tomographic ( OCT ) images of participants in the St and ard Care vs Corticosteroid for Retinal Vein Occlusion ( SCORE ) Study . METHODS Optical coherence tomograms were taken at clinical sites with the Stratus OCT using fast macular and crosshair scan protocol s. Paper prints of images were evaluated at a central reading center . Quality evaluation identified the accuracy of OCT-measured retinal thickness data and was categorized as good , fair , borderline , or ungradable . Manual measurement of center point thickness was performed on borderline images . Morphological evaluation identified cystoid spaces , subretinal fluid , and vitreoretinal interface abnormalities . Reproducibility of grading was assessed through formal quality control exercises . RESULTS A r and omly selected set of 106 images was identified for quality control . The first 2 annual re grade s showed 91 % and 89 % inter grade r agreement for OCT quality . Intraclass correlation for manually measured center point thickness was 0.99 per year . For morphological variables , inter grade r agreement for cystoid spaces was 83 % and 76 % . Reproducibility for subretinal fluid and vitreoretinal interface abnormalities could not be interpreted owing to their limited presence in the sample . CONCLUSION Optical coherence tomogram evaluation procedures used in the SCORE Study are reproducible and can be used for multicenter longitudinal studies of retinal vein occlusion PURPOSE To assess efficacy and safety of intraocular injections of 0.3 mg or 0.5 mg ranibizumab in patients with macular edema following branch retinal vein occlusion ( BRVO ) . DESIGN Prospect i ve , r and omized , sham injection-controlled , double-masked , multicenter clinical trial . PARTICIPANTS A total of 397 patients with macular edema following BRVO . METHODS Eligible patients were r and omized 1:1:1 to receive monthly intraocular injections of 0.3 mg or 0.5 mg of ranibizumab or sham injections . MAIN OUTCOME MEASURES The primary efficacy outcome measure was mean change from baseline best-corrected visual acuity ( BCVA ) letter score at month 6 . Secondary outcomes included other parameters of visual function and central foveal thickness ( CFT ) . RESULTS Mean ( 95 % confidence interval [ CI ] ) change from baseline BCVA letter score at month 6 was 16.6 ( 14.7 - 18.5 ) and 18.3 ( 16.0 - 20.6 ) in the 0.3 mg and 0.5 mg ranibizumab groups and 7.3 ( 5.1 - 9.5 ) in the sham group ( P<0.0001 for each ranibizumab group vs sham ) . The percentage of patients who gained > or = 15 letters in BCVA at month 6 was 55.2 % ( 0.3 mg ) and 61.1 % ( 0.5 mg ) in the ranibizumab groups and 28.8 % in the sham group ( P<0.0001 for each ranibizumab group vs sham ) . At month 6 , significantly more ranibizumab-treated patients ( 0.3 mg , 67.9 % ; 0.5 mg , 64.9 % ) had BCVA of > or = 20/40 compared with sham patients ( 41.7 % ; P<0.0001 for each ranibizumab group vs sham ) ; and CFT had decreased by a mean of 337 microm ( 0.3 mg ) and 345 microm ( 0.5 mg ) in the ranibizumab groups and 158 microm in the sham group ( P<0.0001 for each ranibizumab group vs sham ) . The median percent reduction in excess foveal thickness at month 6 was 97.0 % and 97.6 % in 0.3 mg and 0.5 mg groups and 27.9 % in the sham group . More patients in the sham group ( 54.5 % ) received  rescue grid laser  compared with the 0.3 mg ( 18.7 % ) and 0.5 mg ( 19.8 % ) ranibizumab groups . The safety profile was consistent with previous phase III ranibizumab trials , and no new safety events were identified in patients with BRVO . CONCLUSIONS Intraocular injections of 0.3 mg or 0.5 mg ranibizumab provided rapid , effective treatment for macular edema following BRVO with low rates of ocular and nonocular safety events OBJECTIVE To compare patient-reported visual function in those with neovascular age-related macular degeneration treated with ranibizumab or verteporfin photodynamic therapy ( PDT ) .  DESIGN Multicenter , double-masked , phase 3 trial ( ANCHOR ) . Participants were r and omized in a 1:1:1 ratio to receive 0.3 or 0.5 mg of intravitreal ranibizumab plus sham verteporfin or sham injections plus active verteporfin monthly . The National Eye Institute Visual Function Question naire-25 ( NEI VFQ-25 ) was administered at baseline and 1 , 2 , 3 , 6 , 9 , 12 , 18 , and 24 months . MAIN OUTCOME MEASURE Mean change from baseline in NEI VFQ-25 scores at 12 months . RESULTS At 12 months , patients treated with ranibizumab ( 0.3 mg [ n = 137 ] or 0.5 mg [ n = 139 ] ) had mean improvements in NEI VFQ-25 composite scores of 5.9 ( 95 % confidence interval [ CI ] , 3.6 to 8.3 ) and 8.1 ( 95 % CI , 5.3 to 10.8 ) points , respectively ; patients treated with PDT ( n = 142 ) had a mean improvement of 2.2 points ( 95 % CI , -0. 
    Output:
    
The number of citations and the quality of reporting of clinical trials in Brazilian journals of ophthalmology still are low when compared with the foreign journals of ophthalmology with highest Impact Factor ®