Dataset Information

The Ahmed Baerveldt Comparison Study methodology, baseline patient characteristics, and intraoperative complications.

ABSTRACT:

Purpose

The Ahmed Baerveldt Comparison (ABC) Study compares the long-term outcomes and complications of the Ahmed glaucoma valve (AGV; model FP7; New World Medical, Los Ranchos, CA) and the Baerveldt glaucoma implant (BGI; model 101-350; Abbott Medical Optics, Abbott Park, IL).

Design

Multicenter, randomized, controlled clinical trial.

Participants

Two hundred seventy-six glaucoma patients at 16 clinical centers worldwide who were 18 to 85 years of age with inadequately controlled intraocular pressure (IOP; ?18 mmHg) in whom placement of an aqueous shunt was planned.

Methods

Study patients were randomized to undergo implantation of an AGV or a BGI.

Main outcome measures

Failure, defined as IOP >21 mmHg or not reduced by 20% less than baseline or IOP ?5 mmHg (2 consecutive visits after 3 months), additional glaucoma surgery, removal of the implant, or loss of light perception vision.

Results

A total of 276 patients were enrolled between October 2006 and April 2008, including 143 in the AGV group and 133 in the BGI group. The mean age±standard deviation (SD) of patients enrolled was 63±14 years, and 52% were male. The mean baseline IOP±SD was 31.5±11.8 mmHg. Except for a 13% higher prevalence of hypertension in the AGV group, no significant differences in baseline demographic or ocular characteristics were observed between the study groups. Intraoperative complications occurred in 11 (8%) patients in the AGV group and in 16 (12%) patients in the BGI group (P = 0.31).

Conclusions

The ABC Study should yield valuable prospective data comparing 2 commonly used aqueous shunts in clinical practice.

SUBMITTER: Barton K

PROVIDER: S-EPMC3020244 | biostudies-literature | 2011 Mar

REPOSITORIES: biostudies-literature

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Publications

The Ahmed Baerveldt Comparison Study methodology, baseline patient characteristics, and intraoperative complications.

Barton Keith K Gedde Steven J SJ Budenz Donald L DL Feuer William J WJ Schiffman Joyce J

Ophthalmology 20101008 3

<h4>Purpose</h4>The Ahmed Baerveldt Comparison (ABC) Study compares the long-term outcomes and complications of the Ahmed glaucoma valve (AGV; model FP7; New World Medical, Los Ranchos, CA) and the Baerveldt glaucoma implant (BGI; model 101-350; Abbott Medical Optics, Abbott Park, IL).<h4>Design</h4>Multicenter, randomized, controlled clinical trial.<h4>Participants</h4>Two hundred seventy-six glaucoma patients at 16 clinical centers worldwide who were 18 to 85 years of age with inadequately con ...[more]

PMID: 20932581

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Project description:PurposeTo determine the relative efficacy and complications of the Ahmed glaucoma valve (AGV) model FP7 (New World Medical, Ranchos Cucamonga, CA) and the Baerveldt glaucoma implant (BGI) model 101-350 (Abbott Medical Optics, Abbott Park, IL) in refractory glaucoma.DesignMulticenter, randomized, controlled clinical trial.ParticipantsTwo hundred seventy-six patients, including 143 in the AGV group and 133 in the BGI group.MethodsPatients 18 to 85 years of age with refractory glaucoma having intraocular pressure (IOP) of 18 mmHg or more in whom an aqueous shunt was planned were randomized to undergo implantation of either an AGV or a BGI.Main outcome measuresThe primary outcome was failure, defined as IOP >21 mmHg or not reduced by 20% from baseline, IOP ?5 mmHg, reoperation for glaucoma or removal of implant, or loss of light perception vision. Secondary outcomes included mean IOP, visual acuity, use of supplemental medical therapy, and complications.ResultsPreoperative IOP (mean±standard deviation [SD]) was 31.2±11.2 mmHg in the AGV group and 31.8±12.5 mmHg in the BGI group (P = 0.71). At 1 year, mean±SD IOP was 15.4±5.5 mmHg in the AGV group and 13.2±6.8 mmHg in the BGI group (P = 0.007). The mean±SD number of glaucoma medications was 1.8±1.3 in the AGV group and 1.5±1.4 in the BGI group (P = 0.071). The cumulative probability of failure was 16.4% (standard error [SE], 3.1%) in the AGV group and 14.0% (SE, 3.1%) in the BGI group at 1 year (P = 0.52). More patients experienced early postoperative complications in the BGI group (n = 77; 58%) compared with the AGV group (n = 61; 43%; P = 0.016). Serious postoperative complications associated with reoperation, vision loss of ?2 Snellen lines, or both occurred in 29 patients (20%) in the AGV group and in 45 patients (34%) in the BGI group (P = 0.014).ConclusionsAlthough the average IOP after 1 year was slightly higher in patients who received an AGV, there were fewer early and serious postoperative complications associated with the use of the AGV than the BGI.

Project description:BackgroundErenumab has demonstrated effectiveness for prevention of migraine attacks, but the treatment is costly, and a considerable proportion of patients do not respond to it. The Registry for Migraine study (REFORM) was initiated to discover biomarkers that can predict response to erenumab in patients with migraine. The specific objective was to investigate differences in erenumab efficacy based on clinical information, blood-based biomarkers, structural and functional magnetic resonance imaging (MRI), and response to intravenous infusion of calcitonin gene-related peptide (CGRP). In this first report of the REFORM study, we provide a comprehensive description of the study methodology, and present the baseline characteristics of the study population.MethodsThe REFORM study was a single-center, prospective, longitudinal cohort study in adults with migraine who were scheduled to receive preventive treatment with erenumab as part of a separate, open-label, single-arm phase IV trial. The study included four periods: a 2-week screening period (Weeks -6 to -5), 4-week baseline period (Week -4 to Day 1), 24-week treatment period (Day 1 to Week 24), and a 24-week follow-up period without treatment (Week 25 to Week 48). Demographic and clinical characteristics were recorded using a semi-structured interview, whilst outcome data were obtained using a headache diary, patient-reported outcomes, blood sampling, brain MRI, and responsiveness to intravenous infusion of CGRP.ResultsThe study enrolled 751 participants, with a mean age ± SD of 43.8 ± 12.2 years, of which 88.8% (n = 667) were female. At enrollment, 64.7% (n = 486) were diagnosed with chronic migraine, and 30.2% (n = 227) had history of aura. The mean monthly migraine days (MMDs) was 14.5 ± 7.0. Concomitant preventive medications were used by 48.5% (n = 364) of the participants, and 39.9% (n = 300) had failed ≥ 4 preventive medications.ConclusionThe REFORM study enrolled a population with a high migraine burden and frequent use of concomitant medications. The baseline characteristics were representative of patients with migraine in specialized headache clinics. Future publications will report the results of the investigations presented in this article.Trial registrationThe study and sub-studies were registered on ClinicalTrials.gov (NCT04592952; NCT04603976; and NCT04674020).

Dataset Information

The Ahmed Baerveldt Comparison Study methodology, baseline patient characteristics, and intraoperative complications.

Purpose

Design

Participants

Methods

Main outcome measures

Results

Conclusions

Publications

The Ahmed Baerveldt Comparison Study methodology, baseline patient characteristics, and intraoperative complications.

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