Biomedical subjects

AGIS Investigators

Publications and source records attributed to AGIS Investigators.

6 recordsLinked to original sources

PubMed2004

The Advanced Glaucoma Intervention Study (AGIS): 13. Comparison of treatment outcomes within race: 10-year results.

OBJECTIVE: To present for black and white patients with medically uncontrolled glaucoma 10-year results of treatment with 1 of 2 randomly assigned surgical intervention sequences. DESIGN: Randomized clinical trial. PARTICIPANTS: Three hundred thirty-two black patients (451 eyes) and 249 white patients (325 eyes). Eyes had glaucoma that could not be controlled with medications alone. METHODS: Eyes were randomly assigned to 1 of 2 sequences: argon laser trabeculoplasty (ALT)-trabeculectomy-trabeculectomy (ATT) or trabeculectomy-ALT-trabeculectomy (TAT). Second and third interventions were offered after failure of the preceding intervention. Minimum required intraocular pressure (IOP) for intervention failure ranged upward from 18 mmHg, the value depending on whether recent optic disc or visual field (VF) deterioration occurred, and on the magnitude of the field defect. Patients were observed every 6 months, with total potential follow-up ranging from 8 years, 4 months to 13 years. MAIN OUTCOME MEASURES: The averages over follow-up of (1) the percentage of eyes having moderate loss of VF and (2) the percentage of eyes having moderate loss of visual acuity (VA). RESULTS: Race-treatment interactions in VF and VA loss are significant for the 2 main outcome measures; therefore, results of treatment sequence differences are presented by race. In black patients the average percent of eyes with VF loss was less in the ATT sequence than in the TAT sequence, a difference that is not statistically significant at any visit. In white patients, conversely, after 18 months the average percent of eyes with VF loss was less in the TAT sequence, a difference that increases and is statistically significant in years 8 to 10. In both black and white patients, the average percent of eyes with VA loss was less in the ATT sequence; this difference is statistically significant throughout 10 follow-up years in black patients and is statistically significant only for the first year in white patients. In both black and white patients, average IOP reductions were greater in the TAT sequence, though the TAT-ATT difference was substantially greater in white patients. In both black and white patients, first-intervention failure rates were substantially lower for trabeculectomy than for trabeculoplasty. Ten-year cumulative incidence of unilateral VF impairment comparable to legal blindness was modest in eyes of black (ATT 11.9%, TAT 18.5%) and white (ATT 9.9%, TAT 7.3%) patients. CONCLUSIONS: Although IOP was lowered in both sequences in black and white patients with medically uncontrolled glaucoma, long-term visual function outcomes were better for the ATT sequence in black patients and better for the TAT sequence in white patients.

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PubMed2004

The Advanced Glaucoma Intervention Study (AGIS): 14. Distinguishing progression of glaucoma from visual field fluctuations.

PURPOSE: To determine the least worsening of a visual field (VF) and the least number of confirming tests needed to identify progression of glaucomatous VF defects. DESIGN: Cohort study of participants in a clinical trial. PARTICIPANTS: Seven hundred fifty-two eyes of 565 patients with advanced glaucoma. METHODS: Visual field tests were quantified with the Advanced Glaucoma Intervention Study (AGIS) VF defect score and the Humphrey Field Analyzer mean deviation (MD). Follow-up was 8 to 13 years. MAIN OUTCOME MEASURES: Two measures based on the AGIS VF defect score: (1) sustained decrease of VF (SDVF), a worsening from baseline by 2 (alternatively, 3 or 4) or more units and sustained for 2 (alternatively, 3) consecutive 6-month visits and (2) after the occurrence of SDVF, the average percent of eyes with worsening by 2 (alternatively, 3 or 4) or more units from baseline. Two similar measures based on MD. RESULTS: Based on the original AGIS criteria for SDVF (a worsening of 4 units in the AGIS score sustained during 3 consecutive 6-month visits), 31% of eyes had an SDVF. The percent of eyes with a sustained event increases by approximately 10% when either the minimum number of units of field loss or the minimum number of 6-month visits during which the loss is sustained decreases by 1. During 3 years of follow-up after a sustained event, a worsening of at least 2 units was found in 72% of eyes that had a 2-visit sustained event. The same worsening was found in 84% of eyes that had a 3-visit sustained event. Through the next 10 years after a sustained event, based on worsening of 2, 3, or 4 units at 2 or 3 consecutive tests, the loss reoccurred, on average, in >/=75% of study eyes. Results for MD are similar. CONCLUSIONS: In patients with advanced glaucoma, a single confirmatory test 6 months after a VF worsening indicates with at least 72% probability a persistent defect when the worsening is defined by at least 2 units of AGIS score or by at least 2 decibels of MD. When the number of confirmatory tests is increased from 1 to 2, the percentage of eyes that show a persistent defect increases from 72% to 84%.

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PubMed2002

The Advanced Glaucoma Intervention Study (AGIS): 11. Risk factors for failure of trabeculectomy and argon laser trabeculoplasty.

PURPOSE: To investigate the association of pre-intervention and post-intervention patient and eye characteristics with failure of argon laser trabeculoplasty (ALT) and trabeculectomy. DESIGN: Cohort study of participants in the Advanced Glaucoma Intervention Study. METHODS: This multicenter study took place between 1988 and 2001. Between 1988 and 1992, 789 eyes of 591 patients aged 35 to 80 years with advanced glaucoma were randomized into one of two surgical treatment sequences: argon laser trabeculoplasty (ALT)-trabeculectomy-trabeculectomy or trabeculectomy-ALT-trabeculectomy. Upon study-defined failure (based on maximum medications, sustained intraocular pressure (IOP) elevation, visual field defect, and disk rim deterioration) of each intervention, patients were offered the subsequent intervention. Potential follow-up was 8 to 13 years. This report is based on data from 779 eyes that had at least 3 months of follow-up. The main outcome measures are failure of ALT and trabeculectomy, whether as first or second interventions. Effect size is measured by the hazard ratio (HR) and its corresponding 95% confidence interval (CI) obtained from Cox multiple regression analysis, where HR corresponds to the coefficient of change in risk associated with a unit increase in a factor. For binary factors, this corresponds to the change in risk in eyes with the factor relative to the risk in eyes without the factor. RESULTS: Pre-intervention factors associated with failure of ALT are younger age (HR = 0.98, CI = 0.96-0.99, P =.009) and higher IOP (1.11, 1.08-1.15, P <.001). Pre-intervention factors associated with failure of trabeculectomy are younger age (HR = 0.97, CI = 0.95-0.99, P =.005) and higher IOP (1.04, 1.01-1.06, P =.002), as well as diabetes (2.86, 1.88-4.36, P <.001) and any postoperative complication (1.99, 1.35-2.93, P <.001). Individual postoperative complications significantly associated with increased risk of failure of trabeculectomy are elevated IOP (3.4, 1.9-6.1, P <.001) and marked inflammation (2.4, 1.3-4.6, P =.006). CONCLUSIONS: In this study, ALT failure was associated with younger age and higher pre-intervention IOP. Trabeculectomy failure was associated with younger age, higher pre-intervention IOP, diabetes, and one or more postoperative complications, particularly elevated IOP and marked inflammation.

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PubMed2002

The Advanced Glaucoma Intervention Study (AGIS): 12. Baseline risk factors for sustained loss of visual field and visual acuity in patients with advanced glaucoma.

PURPOSE: To examine the relationships between baseline risk factors and sustained decrease of visual field (SDVF) and sustained decrease of visual acuity (SDVA). DESIGN: Cohort study of participants in the Advanced Glaucoma Intervention Study (AGIS). METHODS: This multicenter study enrolled patients between 1988 and 1992 and followed them until 2001; 789 eyes of 591 patients with advanced glaucoma were randomly assigned to one of two surgical sequences, argon laser trabeculoplasty (ALT)-trabeculectomy-trabeculectomy (ATT) or trabeculectomy-ALT-trabeculectomy (TAT). This report is based on data from 747 eyes. Eyes were offered the next intervention in the sequence upon failure of the previous intervention. Failure was based on recurrent intraocular pressure elevation, visual field defect, and disk rim criteria. Study visits occurred every 6 months; potential follow-up ranged from 8 to 13 years. For each intervention sequence, Cox multiple regression analyses were used to examine the baseline characteristics for association with two vision outcomes: SDVF and SDVA. The magnitude of the association is measured by the hazard ratio (HR), where HR for binary variables is the relative change in the hazard (or risk) of the outcome in eyes with the factor divided by the hazard in eyes without the factor, and HR for continuous variables is the relative change in the hazard (or risk) of the outcome in eyes with a unit increase in the factor. RESULTS: Characteristics associated with increased SDVF risk in the ATT sequence are: less baseline visual field defect (hazard ratio [HR] = 0.86, P <.001, 95% CI = 0.82-0.90), male gender (HR = 2.23, P <.001, 1.54-3.23), and worse baseline visual acuity (HR = 0.96, P =.001, 0.94-0.98); in the TAT sequence: less baseline visual field defect (HR = 0.93, P =.001, 0.89-0.97) and diabetes (HR = 1.87, P =.007, 1.18-2.97). Characteristics associated with increased SDVA risk in both treatment sequences are better baseline acuity (ATT: HR = 1.05, P <.001, 1.02-1.09; TAT: HR = 1.06, P <.001, 1.03-1.08), older age (ATT: HR = 1.05, P =.001, 1.02-1.08; TAT: HR = 1.04, P =.002, 1.01-1.06), and less formal education (ATT: HR = 1.92, P =.001, 1.29-2.88; TAT: HR = 1.77, P =.002, 1.22-2.54). CONCLUSIONS: For SDVF, risk factors were better baseline visual field in both treatment sequences, male gender, and worse baseline visual acuity in the ATT sequence, and diabetes in the TAT sequence. For SDVA, risk factors in both treatment sequences were better baseline visual acuity, older age, and less formal education.

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PubMed2001

The Advanced Glaucoma Intervention Study (AGIS): 9. Comparison of glaucoma outcomes in black and white patients within treatment groups.

PURPOSE: To compare in eyes of black and white patients the progression of glaucoma after failure of medical therapy and upon start of surgical intervention. DESIGN: Cohort study analysis of data from a randomized clinical trial. METHODS: This multicenter study included open-angle glaucoma patients who had failed medical therapy: 451 eyes of 332 black patients, 325 eyes of 249 white patients. Eyes were randomly assigned to an argon laser trabeculoplasty (ALT)-trabeculectomy-trabeculectomy (ATT) sequence or a trabeculectomy-ALT-trabeculectomy (TAT) sequence; they had been followed for 7 to 11 years at database closure. Main outcome measures were decrease of visual field (DVF), sustained decrease of visual field (SDVF), decrease of visual acuity (DVA), sustained decrease of visual acuity (SDVA), and failure of first surgical glaucoma intervention. Statistical methods included logistic regression to obtain average adjusted black-white odds ratios for binary outcomes, and Cox regression to estimate adjusted black-white risk ratios for time-to-event outcomes. RESULTS: In the ATT sequence blacks were at lower risk than whites of failure of first intervention (ALT, RR = 0.68, P = 0.040). In the TAT sequence blacks were at higher risk than whites of failure of the first intervention (trabeculectomy, RR = 1.79, P = 0.033), of intraocular pressure > or =18 mm Hg (average OR = 1.41, P = 0.026), and of DVF (average OR = 1.78, P = 0.007). In both treatment sequences, the average number of prescribed medications was greater for blacks than whites (P < or = 0.002). CONCLUSIONS: The results support the hypothesis that after failure of medical therapy and upon initiation of surgical intervention, an initial intervention with trabeculectomy retards the progression of glaucoma more effectively in white than in black patients. The data provide a weak suggestion that an initial surgical intervention with ALT retards the progression of glaucoma more effectively in black than in white patients.

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PubMed1994

The Advanced Glaucoma Intervention Study (AGIS): 1. Study design and methods and baseline characteristics of study patients.

Medical therapy has been the standard initial treatment for open-angle glaucoma. When some visual field has been lost and maximum tolerated and effective medical therapy does not succeed in controlling the disease, the patient is considered to have advanced glaucoma, and the first of a potential sequence of surgical treatments is usually indicated. Little is known about the long-term course and prognosis of advanced glaucoma or about the long-term effectiveness of sequential surgical treatments in controlling the disease and preventing vision loss and blindness. The Advanced Glaucoma Intervention Study was designed to study, in advanced glaucoma, the long-term clinical course and prognosis, and, in a randomized trial, the comparative outcomes of two sequences of surgical treatments. Toward these goals, 789 eyes in 591 patients were enrolled at 11 clinical centers between 1988 and 1992. Follow-up will continue until 1996. Eyes were randomly assigned to one of two sequences of surgical treatments. One sequence begins with argon laser trabeculoplasty (ALT), is followed by trabeculectomy, an incisional surgical filtering procedure, should ALT fail to control the disease, and by a second trabeculectomy should the first trabeculectomy fail. The other sequence begins with trabeculectomy, is followed by ALT should the trabeculectomy fail, and by a second trabeculectomy should ALT fail. The main outcome of interest is visual function (visual field and visual acuity). Other important outcomes are intraocular pressure, complications of surgery, time to treatment failure, and extent of need for additional medical therapy. We present in this paper the rationale, objectives, design and methods of the study, and the baseline characteristics of study patients and eyes.

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