Dataset Information

Intraocular pressure control and long-term visual field loss in the Collaborative Initial Glaucoma Treatment Study.

ABSTRACT:

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.

SUBMITTER: Musch DC

PROVIDER: S-EPMC3161134 | biostudies-literature | 2011 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Intraocular pressure control and long-term visual field loss in the Collaborative Initial Glaucoma Treatment Study.

Musch David C DC Gillespie Brenda W BW Niziol Leslie M LM Lichter Paul R PR Varma Rohit R

Ophthalmology 20110520 9

<h4>Objective</h4>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).<h4>Design</h4>Longitudinal, randomized clinical trial.<h4>Participants</h4>We included 607 participants with newly diagnosed OAG.<h4>Methods</h4>Study participants were randomly assigned to initial treatment with medications or trabeculectomy, and underwent examination at 6-month intervals. Standardized testi ...[more]

PMID: 21600658

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Project description:PurposeTo 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).DesignThe CIGTS was a randomized, multicenter clinical trial comparing initial treatment with topical medications to trabeculectomy for 607 participants with newly diagnosed glaucoma.ParticipantsThree hundred seven participants randomized to the medication arm of the CIGTS.MethodsParticipants 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 measureMean deviation over time.ResultsThree 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).ConclusionsThis longitudinal assessment demonstrated a statistically and clinically significant association between medication nonadherence and glaucomatous vision loss.

Project description:ImportanceRates of visual field (VF) progression vary among patients with glaucoma. Knowing the rate of progression of individual patients would allow appropriately aggressive therapy for patients with high rates of visual loss and protect those with low rates from unnecessary therapy.ObjectiveTo compare 3 pointwise methods of estimating the rate of VF progression in glaucoma.Design, setting, and participantsThis retrospective, observational cohort study included 729 eyes of 567 consecutive patients with primary open-angle glaucoma who had at least 6 reliable VFs and at least 3 years of follow-up. One hundred seventy-six patients (257 eyes) were treated at a tertiary glaucoma center; in addition, data were collected from 391 participants (472 eyes) in the Advanced Glaucoma Intervention Study. Data were collected from May 1988 to November 2004 and analyzed from October 2018 to February 2019.ExposuresEstimates of VF progression were measured with guided progression analysis (GPA), pointwise linear regression (PLR), and the glaucoma rate index (GRI). A subgroup analysis was performed in a subset of patients with likely VF progression and likely VF stability.Main outcomes and measuresProportion of VF series detected as progressing, estimates of false-positive proportions, time to detect progression, and agreement among measures.ResultsAmong the 567 patients included in the analysis, mean (SD) age was 65.6 (9.7) years, 300 (52.9%) were female, and 295 (52.0%) were white. The median baseline mean deviation was -6.7 (interquartile range [IQR], -11.6 to -3.5) dB; the median follow-up time, 8.9 (IQR, 7.3-10.4) years. The proportion of eyes labeled as progressing was 27.7% according to the GPA, 33.5% according to the PLR, and 52.9% according to the GRI; pairwise differences for GRI vs PLR were 20% (95% CI, 17%-23%); for GRI vs GPA, 25% (95% CI, 22%-29%); and for PLR vs GPA, 6% (95% CI, 3%-9%; P < .001 for all comparisons, McNemar test). The shortest median time to progression was with the GRI (8.8 [IQR, 2.4-10.5 years), compared with the GPA and PLR (both >16 years). The hazard ratio of VF progression for GRI vs PLR (reference) was 11.3 (95% CI, 9.2-13.7); for GRI vs GPA (reference), 18.1 (95% CI, 14.5-22.6); and for PLR vs GPA (reference), 1.5 (95% CI, 1.3-1.9; P < .001 for all comparisons, Cox proportional hazards regression). These results held in the subgroup with likely progression; the proportions of progressing eyes were 73.7% (115 of 156) for GPA, 81.4% (127 of 156) for PLR, and 92.9% (145 of 156) for GRI. Pairwise difference for GRI vs PLR was 11.5% (95% CI, 7.4%-17.6%; P < .001, McNemar test); for GRI vs GPA, 19.2% (95% CI, 12.6%-26.4%; P < .001, McNemar test); and for PLR vs GPA, 7.7% (95% CI, 0.3%-15.7%; P = .08, McNemar test).Conclusions and relevanceThese results suggest GRI can detect long-term VF progression in glaucoma earlier than PLR or GPA. Validation with prospective designs may strengthen the generalizability and value of this method.

Project description:Importance:Twenty-four-hour intraocular pressure (IOP) patterns may provide more information regarding rates of visual field progression than office-hour measurements. However, little is known about the added value of 24-hour monitoring when stratifying glaucoma risk based on rates of progression. Objective:To test the hypothesis that 24-hour IOP-related patterns recorded with a contact lens sensor (CLS) correlate with prior rates of visual field progression. Design, Setting, and Participants:A multicenter, retrospective cohort study was conducted at 50 ophthalmology care centers in 13 countries. Participants included 445 patients (445 eyes) with treated, manifest open-angle glaucoma. The study was conducted from November 8, 1999, to September 17, 2016. Interventions:Twenty-four-hour recordings of IOP-related patterns were prospectively collected with a CLS system. Retrospective visual field data of patients who underwent at least 3 prior reliable visual field tests were examined. Main Outcomes and Measures:Association between CLS variables and rates of visual field mean deviation (MD) change. Results:Of the 445 patients included, 238 (53.5%) were women and 394 (88.5%) were white. The mean (SD) age and MD values at the time of CLS recording were 68.9 (11.2) years and -9.0 (7.0) dB. The mean rate of MD change was -0.46 (0.5) dB/y in 5.2 (3) years of follow-up. After adjusting for baseline MD severity, age, and treatment, the following CLS variables were associated with fast visual field progression: mean peak ratio while awake (??=?-0.021; 95% CI, -0.04 to -0.003), number of long peaks during sleep (??=?0.036; 95% CI, 0.005 to 0.067), night bursts ocular pulse frequency SD (??=?0.027; 95% CI, 0.004 to 0.051), and night bursts ocular pulse amplitude SD (??=?19.739; 95% CI, 1.333 to 38.145). Regression models including CLS variables had better fit than Goldmann IOP when testing the association with rates of progression. Conclusions and Relevance:Results of this study indicate that 24-hour CLS recordings may be associated with prior rates of visual field progression of glaucoma. This association appears to be better than Goldmann mean IOP measured multiple times during office hours. Therefore, the CLS may be useful to assess the risk of future functional loss, even in situations when insufficient historical visual field information is available.

Dataset Information

Intraocular pressure control and long-term visual field loss in the Collaborative Initial Glaucoma Treatment Study.

Objective

Design

Participants

Methods

Main outcome measures

Results

Conclusions

Publications

Intraocular pressure control and long-term visual field loss in the Collaborative Initial Glaucoma Treatment Study.

Similar Datasets

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