title: Validation of a questionnaire for comparing the tolerability of ophthalmic medications. The clinical validity of the treatment satisfaction survey for intraocular pressure in ocular hypertensive and glaucoma patients Quality of life in glaucoma patients: Regression analysis and correlation with possible modifiers The relationship between visual disability and visual field in patients with glaucoma. Treatment and vision-related quality of life in the early manifest glaucoma trial. The Sickness Impact Profile: Development and Final Revision of a Health Status Measure The tube versus trabeculectomy study: design and baseline characteristics of study patients. Brimonidine .2% as a replacement for beta blockers in geriatric patients with glaucoma Switching patients with glaucoma or ocular hypertension from dual therapy to monotherapy: Evaluation of brimonidine as a model Quality of life in newly diagnosed glaucoma patients : The Collaborative Initial Glaucoma Treatment Study. Intraocular Pressure, Safety and Quality of Life in Glaucoma Patients Switching to Latanoprost from Adjunctive and Monotherapy Treatments Psychometric properties of the National Eye Institute Visual Function Questionnaire (NEI-VFQ). NEI-VFQ Field Test Investigators. Effectiveness and Safety of Brimonidine as Adjunctive Therapy for Patients With Elevated Intraocular Pressure in a Large, Open-label Community Trial Relating spontaneous adverse experience reports to scores on a questionnaire querying tolerability. The Italian Version of the 25-Item National Eye Institute Visual Function Questionnaire: Translation, Validity, and Reliability Efficacy of brimonidine as replacement therapy in patients with open-angle glaucoma or ocular hypertension. Psychometric Validation of the National Eye Institute Visual Function Questionnaire — 25 (NEI VFQ-25) French Version Comparison of Efficacy and Tolerability between Two Gel-Forming Timolol Maleate Ophthalmic Solutions in Patients with Glaucoma or Ocular Hypertension Early Manifest Glaucoma Trial: design and baseline data.
abstract: PURPOSE The Comparison of Ophthalmic Medications for Tolerability ( COMTOL ) question naire was developed for use in clinical trials to compare the tolerability of topical ophthalmic medications used in the treatment of glaucoma . The question naire captures the frequency and bother of common side effects ( i.e. , ocular and other local effects , and effects on visual function ) of topical therapy for lowering intraocular pressure . In addition , the question naire measures the extent to which these side effects and any associated limitations in routine living activities interfere with health-related quality of life , medication compliance , and patient satisfaction with the medication . This study was design ed to assess the measurement characteristics of the COMTOL question naire . METHODS The internal consistency , reliability , reproducibility , construct validity , discriminant validity , and responsiveness of the question naire were assessed in 70 adult patients with glaucoma in a clinical trial comparing timolol and pilocarpine . RESULTS The question naire showed good-to-excellent internal consistency ( 0.73 to 0.98 ) , reliability ( 0.76 to 0.94 ) , and reproducibility ( 0.75 to 0.93 ) . In general , there was a strong correlation in the expected direction between the frequency and bother of side effects and patient-perceived global measures . The question naire discriminated between patients receiving timolol and patients receiving pilocarpine . The question naire demonstrated significant responsiveness to change . CONCLUSIONS The COMTOL question naire showed acceptable measurement characteristics for inclusion as a tolerability measure to supplement spontaneous adverse event reporting in clinical trials of topical ophthalmic therapy Purpose To provide initial validation of the Treatment Satisfaction Survey-Intraocular Pressure ( TSS-IOP ) quality -of-life survey that analyses specific issues related to side effects , patient satisfaction , and compliance . Methods A prospect i ve , observational cohort of 250 consecutive patients with primary open-angle glaucoma or ocular hypertension was administered the TSS-IOP survey . Results Factors that correlated with patient satisfaction included perceived effectiveness of the medicine ( F=7.47 , P<0.001 ) , ocular irritation ( F=6.06 , P<0.001 ) , conjunctival hyperaemia ( F=4.40 , P<0.001 ) , ease of use ( F=8.52 , P<0.001 ) , and convenience of use ( F=6.90 , P<0.001 ) . Patient compliance , acceptance of their illness , and knowledge of glaucoma were also related to perceived effectiveness of the medicine ( P<0.001 ) , ease of use ( P<0.05 ) and convenience ( P<0.001 ) . Physician ratings of patient pressure control , side effects , and instillation problems also were significantly correlated to patient satisfaction ( R=0.13–0.26 , P=0.05–0.001 ) . The physician ratings of patient compliance , however , were not significantly related to any dimension of patient satisfaction ( P>0.05 ) . Among monotherapy prostagl and in treatments , latanoprost demonstrated statistically greater satisfaction than bimatoprost or travoprost regarding conjunctival hyperaemia ( P<0.05 ) and eye irritation ( P<0.01 ) . Conclusions This study provides initial evidence that patient satisfaction may be related to compliance , perceived effectiveness of treatment , adverse side effects , ease and convenience of use , acceptance of illness , and knowledge of glaucoma PURPOSE To verify the quality of life in a Brazilian glaucoma population and the influence of possible modifiers ( e.g. , visual acuity , visual field impairment ) . METHODS Forty-five consecutive patients from CEROF - Federal University of Goiás , Brazil were included prospect ively in the study . The quality of life was assessed using the Portuguese version of the VFQ . Possible modifiers were evaluated , initially separately with the Spearman 's Correlation and then together in a regression model . RESULTS The mean age was 59.6 ± 12.4 years .  The mean quality of life score was 79 ± 15 ( range 45 - 100 ) . Age ( r = −0.402 , p = 0.006 ) , visual acuity in the better eye ( r = −0.497 , p = 0.001 ) and in the worse eye ( r = −0.608 , p < 0.001 ) , Hodapp-Parrish- And erson visual field grading scale in the better ( r = −0.353 , p = 0.01 ) and worse eye ( r = −0.387 , p = 0.009 ) , visual field Mean Deviation ( MD ) in the better ( r = 0.355 , p = 0.01 ) and worse eye ( r = 0.320 , p = 0.04 ) and ability to perform a visual field test in both eyes ( r = −0.397 , p = 0.007 ) were significantly correlated with the quality of life scores . However , only age ( younger , better quality of life , p = 0.008 ) and visual acuity in the better eye ( direct relation , p = 0.04 ) were significant in the regression model ( r = 0.633 , r2 = 0.401 ) . CONCLUSIONS The VFQ may be a useful tool to assess the quality of life in glaucoma patients . The preliminary results indicate that age and visual acuity in the better eye are the main factors related to the quality of life in these patients PURPOSE To evaluate the relationship between visual disability and the remaining visual field in glaucoma patients . DESIGN Prospect i ve noncomparative survey . PARTICIPANTS One hundred forty-seven Japanese patients with glaucoma were examined . METHODS Using a previously developed question naire , we assessed the relationship between visual disability indices and both the visual field examined using program 30 - 2 of the Humphrey Field Analyzer and visual acuity . MAIN OUTCOME MEASURES Pearson 's correlation coefficients between visual disability indices and the 22 visual field and 2 visual acuity measurements were calculated . Multiple regression analysis with stepwise variable selection identified factors significantly contributing to visual disability . RESULTS We identified a significant correlation between visual disability and both the visual field and visual acuity measurements collected . Of the factors examined , retinal sensitivity in the lower hemifield within 5 degrees of the fixation and visual acuity in the better eye significantly contributed to all the item and total disability indices ( DIs ) , measurements of the degree of visual disability as evaluated by the question naire ; visual acuity in the worse eye contributed to two of the seven item DIs , as well as the total DI . The R value for total DI ( R = 0.87 , P < 0.0001 ) indicated that approximately 76 % of the visual disability could be explained by these factors . CONCLUSIONS The Japanese glaucoma patients ' visual disability is explained primarily by retinal sensitivity in the lower hemifield within 5 degrees of the fixation and visual acuity in the better eye and secondarily by visual acuity in the worse eye PURPOSE To evaluate the effect of treatment , visual function , and other factors on vision-targeted health-related quality of life ( HRQOL ) of patients with early glaucoma . DESIGN R and omized clinical trial . PARTICIPANTS Two hundred fifty-five patients with newly detected open-angle glaucoma and repeatable early visual field ( VF ) defects , 50 to 80 years old ( 66 % female ) . METHODS Patients were r and omized to receive either betaxolol plus laser trabeculoplasty in eligible eye(s ) or no initial treatment and had ophthalmologic examinations every 3 months . A Swedish translation of the 25-item National Eye Institute Visual Function Question naire ( NEI VFQ-25 ) was self-administered at 2 follow-up visits ( 3 and 6 years after r and omization ) . MAIN OUTCOME Multiple linear regression analyses determined the effect of treatment and other factors on ( 1 ) VFQ-25 composite scores at the first administration and ( 2 ) change in scores between administrations . RESULTS Two hundred thirty-three patients had 1 NEI VFQ-25  administration and 167 patients had 2 administrations . Internal consistency reliability was high for the composite VFQ-25 score ( Cronbach alpha = 0.88 ) and satisfactory ( alpha > or = 0.76 ) for most subscale scores . At the first administration , the composite score was high ( 88.8+/-11.7 ) . Mean subscale scores were also generally high ( 98.0 - 58.3 ) and were similar for each study group when analyzed separately . Most lower subscale scores were modestly but significantly related to worse visual acuity ( VA ) or mean deviation ( MD ) ( better eye , r = 0.15 - 0.35 ) . Composite scores were similar for treated and untreated patients . Lower composite scores were associated with low VA in the better eye ( worse than 0.70 ) and worse perimetric MD ( < 4.16 decibels ) and nuclear lens opacities ( Lens Opacities Classification System II grade > or = 2 ) , but not with age , gender , VF progression , intraocular pressure , cardiovascular disease , or hypertension . Between VFQ-25 administrations , larger decreases in the composite score were associated with larger decreases in VA ( P<0.05 ) , female gender ( P = 0.001 ) , and older age at first administration ( P = 0.006 ) . Treatment ( assigned at r and omization or later in the study ) was not associated with change in HRQOL . CONCLUSIONS Results suggest that absence or delay of treatment did not influence vision-targeted HRQOL in these newly diagnosed glaucoma patients . However , visual function affected vision-targeted quality of life up to 6 years after Early Manifest Glaucoma Trial enrollment The final development of the Sickness Impact Profile ( SIP ) , a behaviorally based measure of health status , is presented . A large field trial on a r and om sample of prepaid group practice enrollees and smaller trials on sample s of patients with hyperthyroidism , rheumatoid arthritis and hip replacements were undertaken to assess reliability and validity of the SIP and provide data for category and item analyses . Test-retest reliability ( r = 0.92 ) and internal consistency ( r = 0.94 ) were high . Convergent and discriminant validity was evaluated using the multitrait – multi method technique . Clinical validity was assessed by determining the relationship between clinical measures of disease and the SIP scores . The relationship between the SIP and criterion measures were moderate to high and in the direction hypotheszed . A technique for describing and assessing similarities and differences among groups was developed using profile and pattern analysis . The final SIP contains 136 items in 12 categories . Overall , category , and dimension scores may be calculated PURPOSE The Tube Versus Trabeculectomy ( TVT ) Study will compare the safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in patients with previous intraocular surgery . DESIGN Multicenter r and omized clinical trial . METHODS SETTING 17 Clinical Centers . STUDY POPULATION Patients 18 to 85 years of age who have undergone previous trabeculectomy , cataract extraction with intraocular lens implantation , or both and have inadequately controlled glaucoma with intraocular pressure ( IOP ) > or=18 mm Hg and < or=40 mm Hg on tolerated medical therapy . INTERVENTIONS Study patients were r and omized to undergo placement of a 350-mm(2 ) Baerveldt glaucoma implant or trabeculectomy with mitomycin C ( 0.4 mg/ml for 4 minutes ) . MAIN OUTCOME MEASURES IOP , complication rates , visual acuity , visual field , quality of life , reoperations for glaucoma , and need for supplemental medical therapy . RESULTS A total of 212 patients were enrolled between October 1999 and April 2004 . The age of the study population was 71.0 + /- 10.4 years ( mean + /- SD ) , and 53 % were women . The baseline  IOP  was 25.3 + /- 5.3 mm Hg ( mean + /- SD ) . There were no significant differences in the demographic and ocular characteristics between the 2 treatment groups . CONCLUSIONS Practice patterns vary in the surgical management of glaucoma , and there are differing opinions among glaucoma surgeons regarding the preferred surgical approach in patients who have undergone previous cataract extraction and /or failed filtering surgery . Forthcoming data from the TVT Study should provide valuable information comparing two surgical procedures commonly used in this patient population This 3-month multicenter , open-label study of 89 geriatric patients with glaucoma evaluated the substitution of brimonidine twice daily for topical beta blockers that had been used for at least 6 months . The primary outcome measures were reduction in intraocular pressure ( IOP ) from baseline at 2 hours postdose , change in cardiac and respiratory function , quality of life , and patient satisfaction . Patients were queried about adverse events at each visit and completed a  quality -of-life question  naire at the final evaluation . In this cohort with a mean age of 75.4 years , the average duration of topical beta-blocker therapy was 5 years . Brimonidine twice daily produced an additional mean reduction in IOP of 8.2 % ( 1.4 mm Hg;P < .001 ) . Eighty-eight percent of patients ( 60/68 ) reported being at least as satisfied with brimonidine as with their previous beta-blocker regimen , and 46 % ( 31/68 ) reported greater satisfaction with brimonidine . Additionally , 40 % of patients ( 27/68 ) noted increased energy after the switch , and 43 % ( 29/68 ) described brimonidine as more soothing than topical beta blockers . In this elderly population , the replacement of topical beta blockers with brimonidine twice daily significantly decreased IOP , improved quality of life , and enhanced patient satisfaction A multicenter open-label study investigated the clinical effectiveness and economic feasibility of switching 142 patients from dual therapy to twice-daily monotherapy with brimonidine for glaucoma or ocular hypertension . Evaluations were performed at baseline and 2 ( visit 2 ) and 8 ( visit 3 ) weeks after the switch . Patients completed a question naire that rated medication-related visual function and satisfaction ( comfort , convenience , vision , ease of remembering to use drops ) at each visit . At visit 3 , investigators , taking into account IOP measurements , safety , and responses on the question naire , recommended whether the patient should remain on brimonidine . A pharmacoeconomic analysis , including the number of visits , cost of medication , and success rates , compared the cost of dual therapy with that of switching to brimonidine monotherapy . Of the 131 patients who completed the study , 77 ( 59 % ) had no change or a decrease in IOP from baseline , and 53 ( 41 % ) had an increase . Investigators recommended that 77 % of the study completers continue to take brimonidine monotherapy . Extending treatment with brimonidine for 12 months would achieve a significant cost savings of 16 % . Brimonidine monotherapy is an efficacious and cost-effective alternative to dual therapy for glaucoma and ocular hypertension . Appropriate monotherapy may be as effective as dual therapy for many patients , and a clinical ly relevant trial such as this may be economically advantageous for testing a switch OBJECTIVE The Collaborative Initial Glaucoma Treatment Study ( CIGTS ) was design ed to determine whether patients with newly diagnosed open-angle glaucoma are better treated initially by medicine or immediate filtering surgery . This paper describes the quality -of-life ( QOL ) measurement approach , instruments included , and the CIGTS participants ' QOL findings at the time of diagnosis . DESIGN Baseline results from a r and omized , controlled clinical trial . PARTICIPANTS Six hundred seven patients from 14 clinical centers were enrolled . INTERVENTION Patients r and omized to initial medication received a stepped medical regimen ( n = 307 ) . Those r and omized to initial surgery underwent a trabeculectomy ( n = 300 ) . The baseline interview was conducted before treatment initiation . All baseline and posttreatment  QOL assessment s were conducted by telephone from a central ized interviewing center . MAIN OUTCOME MEASURES The primary outcome measure described in this paper was QOL . The QOL instrument is multidimensional and incorporates both disease-specific and generic measures , including the Visual Activities Question naire , Sickness Impact Profile , and a Symptom and Health Problem CHECKLIST : RESULTS The correlations between QOL measures and clinical outcomes were in the expected direction , but relatively weak . At initial diagnosis , difficulty with bright lights and with light and dark adaptation were the most frequently reported symptoms related to visual function , whereas visual distortion was the most bothersome . Approximately half of the patients reported at least some worry or concern about the possibility of blindness . Within the Visual Activities Question naire , higher scores on the Peripheral Vision subscale were associated with more field loss ( P < 0.01 ) . In regression analyses controlling for sociodemographics and nonocular comorbidities , increased visual field loss was significantly associated with higher dysfunction among five disease-specific QOL measures ( P < 0.05 ) . CONCLUSIONS Newly diagnosed glaucoma patients reported experiencing some visual function symptoms at the time of diagnosis that would not be intuitively expected based on clinical testing . Some discussion about the association between clinical presentation and worry about blindness may reduce unnecessary concern . These results provide the basis for long-term comparisons of the QOL effects of initial medical and surgical treatment for open-angle glaucoma Purpose To evaluate efficacy , safety and quality of life in ocular hypertensive or open-angle glaucoma patients changed to latanoprost  from previous therapy . Methods A prospect i ve , multicenter , active-controlled design in which qualified patients had their previous therapy substituted for latanoprost  and were followed for at least thee months . Results In 1068 patients , latanoprost was continued 92 % throughout the 36-month observation period . Latanoprost treatment reduced the intraocular pressure (IOP)(p < 0.001 ) when compared to previous monotherapies including : beta-blockers ( -4.0 ± 3.7 mmHg , 42 % ) , alpha-antagonists ( -3.9 ± 3.0 mmHg , 14 % ) , miotics ( -3.8 ± 3.5 mmHg , 2 % ) , or carbonic anhydrase inhibitors ( CAI ) ( -3.8 ± 3.6 mmHg , n = 16 % ) , and adjunctive therapy including : beta-blocker and CAI ( -3.7 ± 3.1 mmHg , n = 12 % ) , alpha-agonist ( -3.7 ± 3.4 mmHg , n = 5 % ) , or pilocarpine ( -3.4 ± 3.7 mmHg , n = 6 % ) , or CAI and alpha-agonist ( -4.6 ± 6.4 mm Hg , n = 2%)(p < 0.0017 ) . The most common adverse event with latanoprost was ocular allergy ( 1.5 % incidence ) . Patients showed a preference for latanoprost for many systemic and ocular quality of life measures on a non-vali date d question naire ( p < 0.05 ) . Conclusions In a clinical setting , patients who have their mono- and adjunctive therapy treatment substituted for latanoprost may on average experience reduced IOP , deceased side effects and increased quality of life measures OBJECTIVE To test the reliability and validity of the 51-item Field Test Version of the National Eye Institute Visual Function Question naire ( NEI-VFQ ) across 5 common chronic eye conditions . DESIGN Prospect i ve observational cohort study of persons with 1 of 5 chronic eye diseases who were scheduled for nonurgent visits in ophthalmology practice s or had low vision from any cause , and a reference sample of persons without eye disease . SETTING Six university-based ophthalmology practice s and the National Eye Institute Clinical Center , Bethesda , Md. PATIENTS Eligible participants had to have 1 of the following eye conditions : age-related cataracts , age-related macular degeneration , diabetic retinopathy , primary open-angle glaucoma , cytomegalovirus retinitis , or low vision from any cause . Each of the 7 sites also enrolled persons in a reference sample . Reference sample participants had no evidence of underlying eye disease but were scheduled for either screening eye examinations or correction of refractive error . All eligible persons had to be aged 21 years or older , English speaking , and cognitively able to give informed consent and participate in a health status interview . MEASUREMENTS AND MAIN RESULTS To provide the data needed to assess the reliability and validity of the 51-item NEI-VFQ  , all subjects completed an interview that consisted of the 51-item NEI-VFQ , the Medical Outcomes Study 36-Item Short-Form Health Survey , and at least 1 measure of vision-targeted functional status . Estimates of internal consistency and test-retest reproducibility indicate that the 51-item NEI-VFQ is reliable . Tests of association with other scales and clinical variables support the construct validity of the survey . CONCLUSIONS In this cross-sectional study , the 51-item NEI-VFQ seems to be reliable and valid and should be a useful tool for group-level comparisons of vision-targeted , health-related quality of life in clinical research . Additionally , the psychometric properties of the NEI-VFQ were not influenced by the type or severity of the underlying eye disease , suggesting that the measure will provide reproducible and valid data when used across multiple eye conditions Purpose To determine the effectiveness and safety of brimonidine when used in combination with one or more glaucoma medications in patients with glaucoma or ocular hypertension . Methods Post hoc analysis of a multicenter , 2-month , open-label , prospect i ve , clinical trial in which 2,335 patients received brimonidine as monotherapy , replacement therapy , or combination therapy . Patients who received brimonidine as combination therapy ( n = 554 ) were examined in the current analysis . Efficacy was determined by the reduction in intraocular pressure ( IOP ) from baseline before the addition of brimonidine .  Safety and tolerability parameters included adverse events and quality -of-life measures ( e.g. , ocular comfort , energy level , breathing ability , night vision ) . Results Addition of brimonidine to preexisting regimens result ed in an overall mean additional reduction in IOP of 17.9 % ( 4.26 mm Hg ) at month 2 ( P < 0.001 ) . Significant additional IOP lowering was provided by brimonidine in combination with each preexisting regimen evaluated ( P ≤ 0.061 ) . When brimonidine was added to monotherapy with a nonselective & bgr;-blocker , the mean additional IOP reduction was 15.5 % ( 3.61 mm Hg , P < 0.001 ) . Addition of brimonidine to latanoprost monotherapy provided a 32.2 % ( 5.89 mm Hg ) mean additional IOP reduction ( P < 0.001 ) . Addition of brimonidine to combination regimens that included latanoprost provided additional mean decreases in IOP ranging from 15.5 % ( 3.63 mm Hg , P < 0.002 ) to 20.1 % ( 6.62 mm Hg , P < 0.001 ) . All quality -of-life parameters remained high or improved during the study . Mild to moderate adverse events were reported in 5.23 % of patients ( 29 of 552 ) ; 98.1 % of physicians rated brimonidine adjunctive therapy as good or excellent . Conclusions Brimonidine , when added to existing glaucoma regimens , safely and effectively lowered IOP in this community-based trial In this study , we examined the relation between spontaneously reported adverse experiences and responses given on the comparison of ophthalmic medications for tolerability ( COMTOL ) checklist question naire which queries the frequency and bother of specific side-effects known to be associated with topical ophthalmic agents used to treat ocular hypertension or open-angle glaucoma , and the impact that the side-effects have on health-related quality of life . The study was a 4-week , r and omized , open-label , two-period cross-over clinical trial comparing dorzolamide and pilocarpine in 92 patients who were also receiving timolol for the treatment of ocular hypertension or open-angle glaucoma . Patients completed the COMTOL question naire at baseline and at the end of each period and spontaneous reports of adverse experiences ( AEs ) were collected throughout the study by the investigator . Since there were only 3 spontaneously reported AEs related to drug treatment while patients received dorzolamide and since COMTOL scores indicated a low level of side-effects , the analyses were limited to pilocarpine treatment periods . We discovered that during the pilocarpine treatment periods , a large percentage ( 94 % ) of the 47 patients , who failed to spontaneously report any adverse experiences , indicated on the COMTOL that they had experienced side-effects . These discrepancies between the methods of spontaneous reports and a checklist question naire are similar to those previously reported in the literature for other drugs . Unlike previous literature , we went beyond identifying discrepancies with the two reporting methods and we looked for possible explanations for why the discrepancies existed . We discovered that patients who spontaneously reported AEs expressed more bother from these specific side-effects on the question naire than patients who did not spontaneously report AEs . As well , patients who spontaneously reported AEs and discontinued drug as a result of the AEs expressed on the COMTOL the greatest bother from side-effects . This trend of increasing negative impact ( as patients reported AEs and discontinued ) was also observed with COMTOL global question scores on the impact of side-effects on health-related quality of life , the impact of activity limitations on quality of life , satisfaction with medication and compliance with medication . Therefore , spontaneous reporting of side-effects appears to be detecting the most clinical ly meaningful side-effects Objective To test the Italian adaptation of the 25-item National Eye Institute Visual Function Question naire ( NEI-VFQ 25 ) and to investigate its validity and reliability . Methods This prospect i ve observational study enrolled nonhospitalized patients with 1 of 5 chronic eye diseases , and a reference sample of subjects without eye diseases . Eligible participants had to be cognitively able to respond to a health status interview and be affected by 1 of the following eye conditions : senile cataract , age-related macular degeneration , glaucoma , diabetic retinopathy , and cytomegalovirus retinitis or low vision . A control group was composed of subjects with no evidence of underlying eye diseases . The Italian self-administered versions of Medical Outcomes Study Short Form and of the NEI-VFQ 25 were administered to all participants . Reliability and validity of the Italian translation of the NEI-VFQ 25 were tested using statistical methods . Results Statistical analysis points out that the Italian version of the NEI-VFQ 25 has good validity , discriminatory power , internal consistency , and reliability . Conclusions This Italian version of the NEI-VFQ 25 shows psychometric properties comparable to those of the American version , and thus can be used in clinical research as a specific measure of quality of life in patients with chronic eye diseases BACKGROUND Patients with glaucoma or ocular hypertension may have inadequately controlled  intraocular pressure ( IOP ) or experience adverse effects with their current medication regimens . OBJECTIVE This post hoc re analysis determined the effectiveness and tolerability of brimonidine used as replacement therapy in a real-life clinical practice setting . METHODS In this multicenter , open-label , observational , 2-month study , 460 patients received brimonidine  0.2 % as a 1:1 replacement for another antiglaucoma medication in their current regimen . Effectiveness was assessed by calculating the mean additional reduction in IOP from the treated baseline measurement ( before the switch to brimonidine ) to 2 months postbaseline , and by determining physicians ' opinions of treatment effectiveness . Tolerability was determined based on quality -of-life assessment s and recorded adverse events . RESULTS Overall , brimonidine replacement significantly reduced mean ( + /- SEM ) IOP by an additional 2.33 + /- 0.17 mm Hg ( 9.8 % + /- 0.9 % ; P < 0.001 ) . Significant additional reductions in IOP were seen when brimonidine replaced an agent used either as monotherapy or adjunctive therapy , regardless of the drug class of the agent replaced . However , particularly good hypotensive effectiveness and additional lowering of IOP were observed when brimonidine replaced certain medications , including latanoprost ( 12.44 % ; P < 0.003 ) and betaxolol ( 13.56 % ; P < 0.001 ) monotherapy , and latanoprost ( 16.08 % ; P < 0.010 ) adjunctive therapy . The effectiveness of brimonidine was rated as good or excellent by 92.4 % of physicians . All quality -of-life variables remained favorable or improved throughout the study , and brimonidine treatment was well tolerated . CONCLUSIONS Brimonidine 0.2 % used as a 1:1 replacement for monotherapy or adjunctive therapy with other antiglaucoma drugs significantly lowered IOP from that produced by previous therapy and was well tolerated .  Brimonidine offers a useful treatment option in patients who require replacement therapy Abstract Objective : Physicians need reliable , valid and sensitive question naires to assess QOL related to glaucoma or ocular hypertension . This article presents the psychometric properties of the French version of the National Eye Institute Visual Function Question naire — 25 ( NEI VFQ-25 ) . Methods : A mail survey was sent to 20 000 households . The survey identified 581 residents with glaucoma or ocular hypertension . Of these a r and om sample ( n = 204 ) took part in a telephone survey during which the NEI VFQ-25 was completed by eligible patients ( those taking at least one topical treatment for glaucoma or ocular hypertension on the day of the interview ) . Multi-trait analysis was performed to assess the construct validity of the question naire . Internal consistency reliability was assessed using Cronbach ’s α and the average inter-item correlation . Known groups validity was assessed by comparing patients grouped by duration of glaucoma , adjusted for age and gender . Results : One hundred and seventy-three patients participated in the survey . Analysis of convergent validity showed that all of the items in each scale correlated above 0.40 with their own scale except for the ‘ driving ’ scale . The success rate of the discriminant validity ranged from 57.1 % to 100 % except for the ‘ driving ’ scale , which was 7.1 % . Cronbach ’s α coefficients were all above 0.70 except the ‘ driving ’ score . Participants with glaucoma for less than 20 years consistently had better ‘ global ’ , ‘ near vision ’ , ‘ distant vision ’ , ‘ driving ’ , ’ social function ’ and ‘ peripheral vision ’ scores than those with disease of 20 + years duration , indicating better QOL in patients with a shorter disease duration . Conclusion : The NEI VFQ-25 is a vali date d instrument to measure vision-targeted QOL in French population s with glaucoma Purpose : To compare two gel-forming timolol maleate ophthalmic solutions , Timoptol XE ® and Lizmon TG ® , in regard to efficacy and tolerability in patients with glaucoma or ocular hypertension by means of a patient-masked prospect i ve r and omized crossover study . Subjects and Methods : A total of 37 patients with glaucoma or ocular hypertension under treatment with antiglaucoma ophthalmic solutions including 0.5 % twice-daily timolol maleate  participated in this study . Only timolol maleate was withdrawn and either Timoptol XE or Lizmon TG was r and omly allocated . After instillation for 1 month , the other ophthalmic solution was subsequently instilled for another month . Routine ophthalmic examination including slit-lamp examination and intraocular pressure ( IOP ) monitoring was conducted before instillation of gel-forming ophthalmic solutions and just after completing the instillation of each ophthalmic solution . Patient question naire surveys were also performed just after completing the instillation of each ophthalmic solution . Results : Mean IOP , just before the withdrawal of timolol ophthalmic solution , was 16.4 ± 2.9 mm Hg . At the end of Timoptol XE or Lizmon TG instillation , mean IOPs were 16.3 ± 2.5 or 16.3 ± 3.0 mm Hg , respectively . The results of the question naire survey showed no significant difference between Timoptol XE and Lizmon TG in regard to all survey items . Twenty-nine patients ( 78.4 % ) preferred to use gel-forming timolol solutions rather than twice-daily timolol ophthalmic solution . The presence of concurrently used ophthalmic solutions did not effect the incidences of subjective symptoms . The incidences of objective adverse effects were not significantly different between two gel-forming timolol ophthalmic solutions . Conclusion : Both gel-forming timolol ophthalmic solutions could be good choices for glaucoma treatment OBJECTIVES The Early Manifest Glaucoma Trial ( EMGT ) will evaluate the effectiveness of reducing intraocular pressure ( IOP ) in early , previously untreated open-angle glaucoma . Its secondary aims are to explore factors related to glaucoma progression and to study the natural history of the disease . This article describes the EMGT design and presents baseline data . DESIGN R and omized , clinical trial . PARTICIPANTS Newly diagnosed patients 50 to 80 years of age with early glaucomatous visual field defects were mainly identified from a population -based screening of more than 44,000 residents of Malmö and Helsingborg , Sweden . Exclusion criteria were advanced visual field loss ; mean IOP greater than 30 mmHg or any IOP greater than 35 mmHg ; visual acuity less than 0.5 ; and inability to complete follow-up protocol s. INTERVENTIONS After informed consent , patients were r and omized to treatment or no initial treatment with close follow-up . Treated patients had laser trabeculoplasty and started receiving topical betaxolol twice daily in eligible eyes . Follow-up visits include computerized perimetry and tonometry every 3 months and fundus photography every 6 months . Decisions to change or begin treatment are made jointly with the patient when EMGT progression occurs and also later if clinical ly needed . MAIN OUTCOME MEASURES The EMGT progression is defined by sustained increases of visual field loss in three consecutive C30 - 2 Humphrey tests , as determined from computer-based analyses , or by optic disc changes , as determined from flicker chronoscopy and side-by-side comparisons of fundus photographs performed by masked , independent grade rs . RESULTS A total of 255 patients were r and omized between 1993 and 1997 and will be followed for at least 4 years . All had generally good health status ; mean age was 68.1 years , and 66 % were women . At baseline , mean IOP was 20.6 mmHg and 80 % of eyes had IOP less than 25 mmHg . CONCLUSIONS The Early Manifest Glaucoma Trial is the first large r and omized , clinical trial to evaluate the role of immediate pressure reduction , as compared to no initial reduction , in patients with early glaucoma and normal or moderately elevated IOP . Its results will have implication s for : ( 1 ) the clinical management of glaucoma ; ( 2 ) underst and ing the role of IOP and the natural history of glaucoma ; and ( 3 ) evaluating the rationale for glaucoma screening
target: The National Eye Institute Visual Function Question naire-25 , Impact of Vision Impairment and Treatment Satisfaction Survey-Intraocular Pressure had the highest number of positive ratings in the content validity assessment .
  Conclusion This study provides a descriptive catalogue of vision-specific PRO instruments , to inform the choice of an appropriate measure of patient-reported outcomes in a glaucoma context
background: Purpose To identify  vision Patient-Reported Outcomes instruments relevant to glaucoma and assess their content validity .