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Purpose: To evaluate the relationship between medication adherence and visual field progression in participants randomized to the medication arm of the Collaborative Initial Glaucoma Treatment Study (CIGTS)., Design: The CIGTS was a randomized, multicenter clinical trial comparing initial treatment with topical medications to trabeculectomy for 607 participants with newly diagnosed glaucoma., Participants: Three hundred seven participants randomized to the medication arm of the CIGTS., Methods: Participants were followed up at 6-month intervals for up to 10 years. Self-reported medication adherence and visual fields were measured. Medication adherence was assessed by telephone from responses to the question, "Did you happen to miss any dose of your medication yesterday?" The impact of medication adherence on mean deviation (MD) over time was assessed with a linear mixed regression model adjusting for the effects of baseline MD and age, cataract extraction, interactions, and time (through year 8, excluding time after crossover to surgery). Medication adherence was modeled as a cumulative sum of the number of prior visits where a missed dose of medication was reported., Main Outcome Measure: Mean deviation over time., Results: Three hundred seven subjects (306 with adherence data) were randomized to treatment with topical medications and followed up for an average of 7.3 years (standard deviation, 2.3 years). One hundred forty-two subjects (46%) reported never missing a dose of medication over all available follow-up, 112 patients (37%) reported missing medication at up to one third of visits, 31 patients (10%) reported missing medication at one third to two thirds of visits, and 21 patients (7%) reported missing medication at more than two thirds of visits. Worse medication adherence was associated with loss of MD over time (P = 0.005). For subjects who reported never missing a dose of medication, the average predicted MD loss over 8 years was 0.62 dB, consistent with age-related loss (95% confidence interval [CI], 0.17-1.06; P = 0.007); subjects who reported missing medication doses at one third of visits had a loss of 1.42 dB (95% CI, 0.86-1.98; P < 0.0001); and subjects who reported missing medication doses at two thirds of visits showed a loss of 2.23 dB (95% CI, 1.19-3.26; P < 0.0001)., Conclusions: This longitudinal assessment demonstrated a statistically and clinically significant association between medication nonadherence and glaucomatous vision loss., (Copyright © 2019 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Purpose: To characterize longitudinal trends and factors predictive of depressive symptoms following glaucoma diagnosis in Collaborative Initial Glaucoma Treatment Study (CIGTS) participants., Design: Cohort study using follow-up data from a clinical trial., Methods: A total of 607 participants with newly diagnosed open-angle glaucoma were enrolled at 14 clinical centers in the United States from October 1993 through April 1997, randomized to treatment with medication or surgery, and followed every 6 months through 2004. The 8-item Center for Epidemiologic Studies Depression Scale (CES-D) was administered at baseline and follow-up visits. Three outcome measures were investigated: overall CES-D depression score, presence of mild or worse depression (CES-D score ≥ 7), and number of depressive symptoms endorsed., Results: The average baseline CES-D score was 2.4 (SD = 3.8), 12.5% of subjects reported symptoms associated with mild or worse depression, and 55.3% reported at least 1 depressive symptom. By 1 year posttreatment, depression measures decreased (1.5, 6.7%, and 38.4%, respectively), with modest decreases thereafter. Baseline factors predictive of mild or worse depression included worse vision-related quality of life (VRQOL) (odds ratio [OR] = 2.41), female sex (OR = 1.42), younger age (OR per 10 years younger = 1.24), and less than high school education (OR = 2.93); other outcomes showed similar results., Conclusions: Depressive symptoms decreased considerably during the first year after treatment initiation, but were elevated in those with impaired VRQOL. Given the potential of depression to reduce treatment adherence and thus increase the risk of glaucoma progression, eye care providers should ask patients about depressive symptoms, provide reassurance when appropriate, and make referrals as necessary., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Importance: Clinicians would benefit from knowing the association of glaucomatous change in 2 eyes of the same patient., Objective: To estimate the time between initial glaucoma treatment of the study eye (SE) and the need for treatment of the fellow eye (FE) and to ascertain the concordance between rates of progression in SEs and FEs., Design, Setting, and Participants: In this post hoc analysis of participants from the Collaborative Initial Glaucoma Treatment Study, 607 participants with newly diagnosed open-angle glaucoma in 1 or both eyes were followed up for up to 11 years. An SE was designated at baseline and randomized to medical or surgical treatment. By protocol, FEs were treated when eligible or at physician discretion. Survival analysis methods were used to estimate the probability of FE treatment over time and to test baseline and time-dependent predictors of treatment. Disease trajectory was calculated with linear regression as the patient eye-specific slopes of mean deviation (MD) and intraocular pressure (IOP) over time, and correlations between SE and FE trajectories were calculated. Data were collected from October 1993 to December 2004. Data were analyzed from September 2012 to May 2018., Main Outcomes and Measures: Time to FE treatment and slopes over time of MD and IOP in SEs and FEs., Results: Of the 607 included patients, 334 (55.0%) were male and 337 (55.5%) were white, and the mean (SD) age was 58.0 (10.9) years. A total of 291 FEs (47.9%) were treated at baseline, 123 (20.3%) were eventually treated, and 193 (31.8%) never received treatment. The probability of FE treatment for open-angle glaucoma was 0.57 at 1 year and 0.68 at 7 years after randomization. Characteristics significantly associated with an increased hazard of FE treatment included older age (hazard ratio [HR], 1.33; 95% CI, 1.08-1.64; P = .007), hypertension (HR, 1.76; 95% CI, 1.16-2.67; P = .008), higher IOP (HR, 1.24; 95% CI, 1.20-1.29; P < .001), large cup-disc ratio (HR, 1.40; 95% CI, 1.23-1.58; P < .001), and worse MD. Correlations in MD slopes between SEs and FEs initially, eventually, and never treated were 0.73, 0.71, and 0.34, respectively. Comparable correlations in IOP slopes were 0.57, 0.24, and 0, respectively., Conclusions and Relevance: Among patients with newly diagnosed open-angle glaucoma, almost half had initial treatment of both eyes. After 7 years, approximately two-thirds of patients had bilateral treatment. Of the variables predictive of FE treatment, modifiable factors included hypertension and IOP. Slopes of MD were similar between SEs and treated FEs. This implies that SE change is a harbinger of FE change and therefore warrants close surveillance.

Purpose: To assess the relationship of binocular visual function tests with binocular approximations using data from the Collaborative Initial Glaucoma Treatment Study (CIGTS)., Design: Case series based on existing data from a clinical trial., Participants: Six hundred seven patients with newly diagnosed open-angle glaucoma from the CIGTS., Methods: Monocular visual field (VF) and visual acuity (VA) tests were performed at baseline and every 6 months thereafter. Binocular tests of visual function (Esterman VF score, binocular VA) were added to the CIGTS protocol 3 years into the study. The binocular approximations of binocular visual function were better or worse eye, average eye, better or worse location, and binocular summation or pointwise binocular summation. Associations between binocular tests and binocular approximations to represent binocular visual function were assessed with Pearson's correlations (r), as was the relationship between vision-related quality of life (VR QOL; Visual Activities Questionnaire [VAQ] and the 25-item National Eye Institute Visual Function Questionnaire [NEI VFQ-25]) and binocular tests or binocular approximations of visual function., Main Outcome Measures: Binocular visual function (VF and VA) and VR QOL., Results: Five hundred seventy-five patients underwent at least 1 binocular visual function test. The Esterman score was correlated significantly with all binocular approximations of VF, with r values ranging from 0.31 (worse-eye mean deviation [MD]) to 0.42 (better-eye MD; P < 0.0001 for all). Binocular VA showed stronger correlations with binocular approximations, with r values ranging from 0.65 (worse-eye VA) to 0.80 (binocular summation; P < 0.0001 for all). Correlations between the VAQ and Esterman score were stronger in 7 of 9 subscales (r = -0.14 to -0.25; P < 0.05 for all) than correlations with all 7 binocular approximations. In contrast, correlations between the VAQ and binocular VA (r = -0.07 to -0.21) were weaker in all subscales than those with better-eye, average-eye, and binocular summation of VA (r = -0.12 to -0.25), but not different from worse-eye values. These trends also were found in relevant subscales of the NEI VFQ-25., Conclusions: We found limited benefit in binocular testing of VA in the clinical setting as a means of approximating a patient's reported visual functioning. In contrast, we found some benefit in performing binocular VF testing, because the results correlated more closely with reported functioning than binocular approximations., (Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate critically visual field (VF) improvement in participants in the Collaborative Initial Glaucoma Treatment Study (CIGTS)., Design: Prospective, comparative case series from a randomized clinical trial comparing trabeculectomy and topical medications in treating open-angle glaucoma (OAG)., Methods: A total of 607 subjects with newly diagnosed OAG were identified for study. Baseline and follow-up VF tests were obtained and mean deviation (MD) change from baseline over follow-up was analyzed. Clinically substantial change (loss or improvement) was defined as change from baseline of ≥ 3 decibels in MD. Baseline factors were inspected to determine their association with VF improvement in repeated measures regression models., Results: The percentage of participants showing substantial VF improvement over time was similar to that showing VF loss through 5 years after initial treatment, after which VF loss became more frequent. Measures of better intraocular pressure (IOP) control during treatment were significantly predictive of VF improvement, including a lower mean IOP, a lower minimum IOP, and lower sustained levels of IOP over follow-up. Other predictive factors included female sex (odds ratio [OR] = 1.73), visits 1 year prior to cataract extraction (OR = 0.11), and an interaction between treatment and baseline MD wherein surgically treated subjects with worse baseline VF loss were more likely to show VF improvement., Conclusions: In the CIGTS, substantial VF loss and improvement were comparable through 5 years of follow-up, after which VF loss became more frequent. Predictive factors for VF improvement included several indicators of better IOP control, which supports the postulate that VF improvement was real., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Purpose: To estimate minimally important differences (MIDs) for the Visual Activities Questionnaire (VAQ) and the National Eye Institute-Visual Function Questionnaire (NEI-VFQ)., Methods: A total of 607 subjects with newly-diagnosed open-angle glaucoma (OAG) was enrolled in the Collaborative Initial Glaucoma Treatment Study (CIGTS) and randomized to initial treatment with medications or surgery. Subjects underwent an ophthalmic examination and telephone-administered quality of life (QOL) interview before randomization and every six months thereafter. The VAQ and NEI-VFQ were used to assess participants' perceptions of their visual function. Clinical measures included the mean deviation (MD) from Humphrey 24-2 full threshold visual field (VF) testing, and best-corrected visual acuity (VA) measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Anchor-based (using MD and VA) and distribution-based methods were used to estimate MIDs., Results: Anchor-based cross-sectional analyses at 66 months follow-up found a 10-letter increment in better eye VA corresponded to MIDs of 5.2 units for VAQ and 3.8 units for NEI-VFQ total scores. A 3-dB increment in the better eye MD yielded MIDs of 2.6 and 2.3 units for the same two questionnaires. In longitudinal analyses, MIDs for the VAQ were 3.2 units for a 10-letter change of VA and 3.4 units for a 3-dB change in the MD. Distribution-based MIDs were larger., Conclusions: A range of MIDs for the VAQ (2.6-6.5 units) and NEI-VFQ (2.3-3.8 units) was found. Although similar in magnitude, MIDs were sensitive to the MID estimation method, the anchor chosen, and differences between questionnaires. (ClinicalTrials.gov number, NCT00000149.)., (Copyright 2014 The Association for Research in Vision and Ophthalmology, Inc.)

Background/aims: Three types of open-angle glaucoma (OAG)--primary, pigmentary and pseudoexfoliative--are frequently encountered. The aim of this study was to compare demographic, ocular and systemic medical information collected on people with these three OAG types at diagnosis, and determine if the OAG type affected the prognosis., Methods: Information on 607 participants of the Collaborative Initial Glaucoma Treatment Study was accessed. Descriptive statistics characterised their demographic, ocular and medical status at diagnosis. Comparisons were made using analysis of variance and χ(2) or Fisher's exact tests. Multinomial, mixed and logistic regression analyses were also performed., Results: Relative to people with primary OAG, those with pigmentary OAG were younger, more likely to be white, less likely to have a family history of glaucoma, and were more myopic. Those with pseudoexfoliative OAG were older, more likely to be white, more likely to be women, less likely to have bilateral disease, and presented with higher intraocular pressure (IOP) and better visual acuity. The type of glaucoma was not associated with IOP or visual field progression during follow-up., Conclusion: Characteristics of newly diagnosed enrollees differed by the type of OAG. While some of these differences relate to the pathogenesis of OAG type, other differences are noteworthy for further evaluation within population-based samples of subjects with newly diagnosed OAG.

Objective: To evaluate the impact of measures of intraocular pressure (IOP) control on progression of visual field (VF) loss during long-term treatment for open-angle glaucoma (OAG)., Design: Longitudinal, randomized clinical trial., Participants: We included 607 participants with newly diagnosed OAG., Methods: Study participants were randomly assigned to initial treatment with medications or trabeculectomy, and underwent examination at 6-month intervals. Standardized testing included Goldmann applanation tonometry and Humphrey 24-2 full threshold VFs. Summary measures of IOP control during follow-up included the maximum, mean, standard deviation (SD), range, proportion less than 16, 18, 20, or 22 mmHg, and whether all IOP values were less than each of these 4 cutpoints. Predictive models for VF outcomes were based on the mean deviation (MD) from VF testing, and were adjusted for age, gender, race, baseline VF loss, treatment, and time. Each summary IOP measure was included as a cumulative, time-dependent variable, and its association with subsequent VF loss was assessed from 3 to 9 years postrandomization. Both linear mixed models, to detect shifts in MD levels, and logistic models, to detect elevated odds of substantial worsening (≥3 dB), were used., Main Outcome Measures: We measured the MD from Humphrey 24-2 full threshold VF tests., Results: The effect of the summary IOP measures differed between the medicine and surgery groups in models that addressed the continuous MD outcome. After adjustment for baseline risk factors, in the medicine group larger values of 3 IOP control measures-maximum IOP (P = 0.0003), SD of IOP (P = 0.0056), and range of IOP (P<0.0001)-were significantly associated with lower (worse) MD over the 3- to 9-year period. No IOP summary measure was significantly associated with MD over time in the surgery group. The same 3 IOP summary measures were also significantly associated with substantial worsening of MD; however, the effects were similar in both treatment groups. In models predicting inadequate IOP control, consistently significant predictors of higher maximum, SD, and range of IOP included black race, higher baseline IOP, and clinical center., Conclusions: These results support considering more aggressive treatment when undue elevation or variation in IOP measures is observed., (Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)

Purpose: To compare 2 vision-specific functional status measures to each other and to clinical parameters in the Collaborative Initial Glaucoma Treatment Study (CIGTS)., Methods: CIGTS participants completed the Visual Activities Questionnaire (VAQ) and the National Eye Institute-Visual Function Questionnaire (NEI-VFQ) and were tested for visual field (VF) and visual acuity (VA). In all, 426 subjects contributed the VAQ and NEI-VFQ scores at 54 months. Pearson correlations were used to assess associations., Results: The VAQ subscales (range, 0 to 100) that assessed light-dark adaptation (mean=66.1), glare disability (66.4), and acuity/spatial vision (67.7) indicated vision-related functions that CIGTS participants found most difficult. On the NEI-VFQ, subjects reported high levels of visual functioning, with mean >/=90 (out of 100) on the total score and in 9 of 12 subscales. General vision (mean=82.6) received the lowest subscale score. Two subscales common to both questionnaires were highly correlated: VA (r=0.68) and peripheral vision (r=0.77) (both P<0.0001). Correlations between participants' perceptions and clinical measures of visual function were in the expected direction, but weaker. Stronger associations were found between clinical measures and the NEI-VFQ than the VAQ. Better eye VF and worse eye VA had the highest number of significant correlations with subjects' perceptions of their visual function. Increasing VF loss was associated with a significant decrease in the overall and peripheral vision subscale scores from both questionnaires, and also several other subscales., Conclusions: CIGTS patients reported excellent visual function on both the NEI-VFQ and VAQ. These findings will help researchers interested in assessing patients' perceptions of their visual function make an informed selection when choosing between the VAQ and the NEI-VFQ.

Purpose: To compare drivers and nondrivers, and to describe the specific concerns of drivers, among individuals with glaucoma., Methods: Six hundred seven patients with newly diagnosed glaucoma treated at 14 clinical centers of the Collaborative Initial Glaucoma Treatment Study were randomly assigned to initial medicine or surgery and were followed up every 6 months. Driving status (drivers versus nondrivers) and patient-reported visual function were determined by the Visual Activities Questionnaire and the National Eye Institute Visual Function Questionnaire. Clinical evaluation included visual field mean deviation (MD) and visual acuity. Statistical comparisons were made using t, chi(2), and exact tests and regression and Rasch analyses., Results: Drivers were more likely than nondrivers to be male, white, married, employed, and more educated and to have higher incomes and fewer comorbidities. More than 50% of drivers reported at least "some" difficulty performing tasks involving glare, whereas 22% reported at least "some" difficulty with tasks requiring peripheral vision. At 54 months, drivers with moderate/severe bilateral visual field loss (VFL) reported greater difficulty with night driving and tasks involving visual search and visual processing speed than drivers with less bilateral VFL (all P<0.05). Although those who remained drivers over follow-up had better MD in both eyes than those who became nondrivers because of eyesight, a number of drivers had marked VFL., Conclusions: Inquiring about specific difficulties with tasks related to glare, visual processing speed, visual search, and peripheral vision in driving, especially among patients with substantial bilateral visual field damage, will enable physicians to more effectively counsel patients regarding driving.

Purpose: To evaluate factors associated with visual field (VF) progression, using all available follow-up through 9 years after treatment initiation, in the Collaborative Initial Glaucoma Treatment Study (CIGTS)., Design: Longitudinal follow-up of participants enrolled in a randomized clinical trial., Participants: Six hundred seven newly diagnosed glaucoma patients., Methods: In a randomized clinical trial, 607 subjects with newly diagnosed open-angle glaucoma initially were treated with either medication or trabeculectomy. After treatment initiation and early follow-up, subjects were evaluated clinically at 6-month intervals. Study participants in both arms of the CIGTS were treated aggressively in an effort to reduce intraocular pressure (IOP) to a level at or below a predetermined, eye-specific target pressure. Visual field progression was analyzed using repeated measures models., Main Outcome Measures: Visual field progression, measured by Humphrey 24-2 full-threshold testing and assessed by the change in the mean deviation (MD), and an indicator of substantial worsening of the VF (MD decrease of > or =3 dB from baseline), assessed at each follow-up visit., Results: Follow-up indicated minimal change from baseline in each initial treatment group's average MD. However, at the 8-year follow-up examination, substantial worsening (> or =3 dB) of MD from baseline was found in 21.3% and 25.5% of the initial surgery and initial medicine groups, respectively. The effect of initial treatment on subsequent VF loss was modified by time (P<0.0001), baseline MD (P = 0.03), and diabetes (P = 0.01). Initial surgery led to less VF progression than initial medicine in subjects with advanced VF loss at baseline, whereas subjects with diabetes had more VF loss over time if treated initially with surgery., Conclusions: The CIGTS intervention protocol led to a lowering of IOP that persisted over time in both treatment groups. Progression in VF loss was seen in a subset, increasing to more than 20% of the subjects. The findings regarding initial surgery being beneficial for subjects with more advanced VF loss at presentation, but detrimental for patients with diabetes, are noteworthy and warrant independent confirmation., Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Purpose: To evaluate, both at initial glaucoma diagnosis and during treatment, the role of demographic and clinical factors on intraocular pressure (IOP)., Design: Cohort study of patients enrolled in a randomized clinical trial., Participants: Six hundred seven patients with newly diagnosed open-angle glaucoma (OAG) were enrolled at 14 centers in the United States., Methods: After randomization to initial surgery or medications, patients were followed at 6-month intervals. Intraocular pressure was measured by Goldmann applanation tonometry. Predictive factors for IOP at baseline and during follow-up were analyzed using linear mixed models., Main Outcome Measure: Intraocular pressure at baseline and during follow-up., Results: The mean baseline IOP was 27.5 mmHg (standard deviation, 5.6 mmHg). Predictive factors for higher baseline IOP included younger age (0.7 mmHg per 10 years), male gender (2.4 mmHg higher than females), pseudoexfoliative glaucoma (5.4 mmHg higher than primary OAG), and pupillary defect (2.2 mmHg higher than those without a defect). During 9 years of follow-up, both surgery and medications dramatically reduced IOP from baseline levels, but the extent of IOP reduction was consistently greater in the surgery group. Over follow-up years 2 through 9, mean IOP was 15.0 versus 17.2 mmHg for surgery versus medicine, respectively. Predictive associations with higher IOP during follow-up included higher baseline IOP (P<0.0001), worse baseline visual field (mean deviation; P<0.0001), and lower level of education (P = 0.0019). Treatment effect was modified by smoking status: nonsmokers treated surgically had lower IOP than smokers treated surgically (14.6 vs. 16.7 mmHg, respectively; P = 0.0013). Clinical center effects were significant (P<0.0001) in both the baseline and follow-up models., Conclusions: In this large cohort of newly diagnosed glaucoma patients, predictors of pretreatment IOP and IOP measurements over 9 years of follow-up were identified. Our findings lend credence to the postulate that sociodemographic, economic, compliance, or other environmental influences play a role in IOP control during treatment.

Purpose: The objective of this study was to describe the prevalence of fear of blindness (FOB) and the factors associated with FOB during 5 years of follow-up in the Collaborative Initial Glaucoma Treatment Study., Design: Randomized controlled clinical trial., Participants: A total of 607 newly diagnosed patients with open-angle glaucoma were recruited from 14 clinical centers in the United States., Methods: Patients were assigned randomly either to initial medical therapy or initial trabeculectomy. Study participants received clinical examinations and quality-of-life (QOL) evaluations at baseline and 6-month intervals. The QOL questionnaire was administered by trained telephone interviewers at a centralized interviewing center., Main Outcome Measures: The QOL questionnaire included an assessment of FOB, measures of vision-related functioning, and measures of general physical and psychosocial well being. Ordinal logistic regression analyses were used to assess clinical and QOL measures associated with FOB over time., Results: After being told about the glaucoma diagnosis but before randomization, 34% of patients reported at least a moderate amount of FOB. This percent dropped to 11% at 5 years. In multivariable ordinal logistic regression models, younger age, being white, and having less education and a lower income were associated with increased FOB (all P<0.05). At the 36-month follow-up, visual field progression was associated significantly with increased FOB (P = 0.006); visual acuity loss, although related to increased FOB, did not achieve statistical significance (P = 0.327). Self-reported visual function measures explained more of the variation in FOB over time than did demographic, clinical, or physical or psychosocial measures. Initial treatment assignment (medicine or surgery) was not associated with FOB. The most significant correlate over time with FOB was the perceived impact on an individual's ability to perform visual tasks., Conclusions: More attention to reducing glaucoma patients' FOB at diagnosis and over time is warranted. Fear of blindness over time is related more to how much an individual is bothered by their inability to perform visual tasks than to their monocular visual acuity or visual field assessments.

Objectives: To study the incidence of and predictors for cataract extraction (CE) in patients with newly diagnosed glaucoma, the impact of CE on visual function, and changes in the time around CE., Methods: Patients were randomized to medical or surgical treatments for glaucoma at 14 centers and followed up for a median of 7.7 years. Vision-specific quality of life (VS-QOL) data were collected by telephone interview during follow-up of 607 patients randomized to medical or surgical treatments for glaucoma. The occurrence of CE was the signal event. Risk factors were evaluated using survival analyses; changes from before to after CE were evaluated by paired t tests; and trends were estimated by loess regression., Results: During follow-up of 607 patients, CE took place in 99 study eyes. Initial surgery, older age, a more negative spherical equivalent, and a diagnosis of pseudoexfoliative glaucoma conferred a higher risk of CE. Visual field testing before and after CE showed the mean deviation improved but the pattern standard deviation worsened. The VS-QOL improved on most subscales., Conclusions: Initial surgery places a patient with glaucoma at a higher risk of CE. The impact of CE on visual field indexes is mixed-the mean deviation improved but the pattern standard deviation worsened. Most, but not all, VS-QOL subscales were responsive to worsening of cataract prior to and acute improvement in vision after CE.

Purpose: To compare the baseline Collaborative Initial Glaucoma Treatment Study (CIGTS) visual field (VF) score and mean deviation (MD), investigate test-retest variability, and identify variables associated with VF loss and VF measurement variability., Methods: Baseline data from a randomized clinical trial of 607 patients with newly diagnosed open-angle glaucoma were collected at 14 clinical centers. The CIGTS VF score and MD were obtained from 24-2 VF tests (Zeiss-Humphrey Systems, Dublin, CA) at two visits approximately 2 weeks apart., Results: Although most baseline CIGTS VF scores showed limited field loss, 15% (91/607) of patients showed a substantial deficit (VF score >10 on a 0-20 scale). A small but significant learning effect was seen over the two baseline measures for CIGTS VF score and MD. CIGTS VF score and MD correlate highly (r = -0.93); both have high test-retest correlation (0.83 and 0.91, respectively). Variables associated with greater baseline VF loss for both CIGTS VF score and MD include (probabilities for VF only): male sex (P = 0.018), black race (P

Purpose: To report interim outcome data, using all available follow-up through 5 years after treatment initiation, in the Collaborative Initial Glaucoma Treatment Study (CIGTS)., Design: Randomized clinical trial., Participants: Six hundred seven newly diagnosed glaucoma patients., Methods: In a randomized clinical trial, 607 patients with newly diagnosed open-angle glaucoma were initially treated with either medication or trabeculectomy (with or without 5-fluorouracil). After treatment onset and early follow-up, patients were evaluated clinically at 6-month intervals. In addition, quality of life telephone interviews were conducted at similar frequency to the clinical visits. Patients in both arms of CIGTS were treated aggressively in an effort to reduce intraocular pressure (IOP) to a level at or below a predetermined target pressure specific for each individual eye. Visual field (VF) scores were analyzed by time-specific comparisons and by repeated measures models., Main Outcome Measures: VF loss was the primary outcome variable in CIGTS. Secondary outcomes of visual acuity (VA), IOP, and cataract were also studied., Results: On the basis of completed follow-up through 4 years and partially completed through 5 years, VF loss did not differ significantly by initial treatment. Over the entire period of follow-up, surgical patients had a greater risk of substantial VA loss compared with medical patients. However, by 4 years after treatment, the average VA in the two groups was about equal. Over the course of follow-up, IOP in the medicine group has averaged 17 to 18 mmHg, whereas that in the surgery group averaged 14 to 15 mmHg. The rate of cataract requiring removal was greater in the surgically treated group., Conclusions: Both initial medical or initial surgical therapy result in about the same VF outcome after up to 5 years of follow-up. VA loss was greater in the surgery group, but the differences between groups seem to be converging as follow-up continues. When aggressive treatment aimed at substantial reduction in IOP from baseline is used, loss of VF can be seen to be minimal in general. Because 4 to 5 years of follow-up in a chronic disease is not adequate to draw treatment conclusions, these interim CIGTS outcomes do not support altering current treatment approaches to open-angle glaucoma.

Objective: To present interim quality of life (QOL) findings in the Collaborative Initial Glaucoma Treatment Study (CIGTS) using all available follow-up through 5 years from treatment initiation., Design: Randomized controlled clinical trial., Participants: Six hundred seven newly diagnosed patients with open-angle glaucoma from 14 clinical centers., Intervention: Patients were randomly assigned to either initial medical therapy or initial trabeculectomy. After treatment initiation and early follow-up, patients received clinical and QOL evaluations at 6-month intervals. QOL assessments were administered by telephone at a centralized interviewing center., Main Outcome Measures: The CIGTS collected comprehensive QOL information that included both generic and vision-specific QOL measures. This article focuses on initial treatment group differences related to symptom reporting, as measured by a Symptom and Health Problem Checklist, and changes in daily visual functioning, as measured by the Visual Activities Questionnaire (VAQ)., Results: Across both treatment groups, there was an overall decline in the percent of participants reporting symptoms over time. Of 43 possible symptoms, 12 symptoms were reported with greater frequency by the surgically treated group and 7 symptoms more frequently by the medically-treated group. The surgical patients reported more total Symptom Impact Glaucoma (P = 0.005) and, in particular, more bother related to local eye symptoms. Very few treatment group differences were noted in visual functioning, although surgical patients reported more problems with activities related to their visual acuity (P = 0.024). The percentage of patients across treatment groups reporting worry about blindness was 50% at baseline but declined to approximately 25% over time., Conclusions: Overall, the QOL impact reported by the two treatment groups as measured by instruments used in this study is remarkably similar, with relatively few significant study group differences observed after up to 5 years of follow-up in the CIGTS. When significant differences in visual function have been detected using the VAQ, they are consistent with the clinical outcomes. To date, the most persistent QOL finding is the increased impact of local eye symptoms reported by the surgical group compared with the medical group. Although no changes are recommended in the treatment of newly diagnosed glaucoma patients at the time of this interim report, further follow-up will allow for more definitive answers to the QOL impact of these two treatment approaches.

Objective: The Collaborative Initial Glaucoma Treatment Study (CIGTS) was designed 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 randomized, controlled clinical trial., Participants: Six hundred seven patients from 14 clinical centers were enrolled., Intervention: Patients randomized to initial medication received a stepped medical regimen (n = 307). Those randomized to initial surgery underwent a trabeculectomy (n = 300). The baseline interview was conducted before treatment initiation. All baseline and posttreatment QOL assessments were conducted by telephone from a centralized 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 Questionnaire, 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 Questionnaire, 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.