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Postoperative Complications in the Ahmed Baerveldt Comparison Study During Five Years of Follow-up.

ABSTRACT: To compare the late complications in the Ahmed Baerveldt Comparison Study during 5 years of follow-up.Multicenter, prospective randomized clinical trial.setting: Sixteen international clinical centers.Two hundred seventy-six subjects aged 18-85 years with previous intraocular surgery or refractory glaucoma with intraocular pressure of >18 mm Hg.Ahmed Glaucoma Valve FP7 or Baerveldt Glaucoma Implant BG 101-350.Late postoperative complications (beyond 3 months), reoperations for complications, and decreased vision from complications.Late complications developed in 56 subjects (46.8 ± 4.8 5-year cumulative % ± SE) in the Ahmed Glaucoma Valve group and 67 (56.3 ± 4.7 5-year cumulative % ± SE) in the Baerveldt Glaucoma Implant group (P = .082). The cumulative rates of serious complications were 15.9% and 24.7% in the Ahmed Glaucoma Valve and Baerveldt Glaucoma Implant groups, respectively (P = .034), although this was largely driven by subjects who had tube occlusions in the 2 groups (0.8% in the Ahmed Glaucoma Valve group and 5.7% in the Baerveldt Glaucoma Implant group, P = .037). Both groups had a relatively high incidence of persistent diplopia (12%) and corneal edema (20%), although half of the corneal edema cases were likely due to pre-existing causes other than the aqueous shunt. The incidence of tube erosion was 1% and 3% in the Ahmed Glaucoma Valve and Baerveldt Glaucoma Implant groups, respectively (P = .04).Long-term rates of vision-threatening complications and complications resulting in reoperation were higher in the Baerveldt Glaucoma Implant than in the Ahmed Glaucoma Valve group over 5 years of follow-up.

SUBMITTER: Budenz DL

PROVIDER: S-EPMC4901387 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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Postoperative Complications in the Ahmed Baerveldt Comparison Study During Five Years of Follow-up.

Budenz Donald L DL Feuer William J WJ Barton Keith K Schiffman Joyce J Costa Vital P VP Godfrey David G DG Buys Yvonne M YM

American journal of ophthalmology 20151118

<h4>Purpose</h4>To compare the late complications in the Ahmed Baerveldt Comparison Study during 5 years of follow-up.<h4>Design</h4>Multicenter, prospective randomized clinical trial.<h4>Methods</h4>setting: Sixteen international clinical centers.<h4>Study population</h4>Two hundred seventy-six subjects aged 18-85 years with previous intraocular surgery or refractory glaucoma with intraocular pressure of >18 mm Hg.<h4>Interventions</h4>Ahmed Glaucoma Valve FP7 or Baerveldt Glaucoma Implant BG 1 ...[more]

PMID: 26596400

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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:PurposeTo describe postoperative complications encountered in the Primary Tube Versus Trabeculectomy (PTVT) Study during 5 years of follow-up.DesignMulticenter randomized clinical trial.ParticipantsA total of 242 eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 patients in the tube group and 117 patients in the trabeculectomy group.MethodsPatients were enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC, 0.4 mg/ml for 2 minutes).Main outcome measuresSurgical complications, reoperations for complications, visual acuity, and cataract progression.ResultsEarly postoperative complications occurred in 24 patients (19%) in the tube group and 40 patients (34%) in the trabeculectomy group (P = 0.013). Late postoperative complications developed in 27 patients (22%) in the tube group and 32 patients (27%) in the trabeculectomy group (P = 0.37). Serious complications producing vision loss and/or requiring a reoperation were observed in 3 patients (2%) in the tube group and 9 patients (8%) in the trabeculectomy group (P = 0.11). Cataract progression was seen in 65 patients (52%) in the tube group and 52 patients (44%) in the trabeculectomy group (P = 0.30). Surgical complications were not associated with a higher rate of treatment failure (P = 0.61), vision loss (P = 1.00), or cataract progression (P = 0.77) CONCLUSIONS: A large number of surgical complications were observed in the PTVT Study, but most were transient and self-limited. The incidence of early postoperative complications was higher following trabeculectomy with MMC than with tube shunt surgery. The rates of late postoperative complications, serious complications, and cataract progression were similar with both surgical procedures after 5 years of follow-up. Surgical complications did not increase the risk of treatment failure, vision loss, or cataract progression.

Project description:Patients with pacemakers need regular follow-ups which are demanding. Telemonitoring for pacemaker can provide a new opportunity to avoid follow-up visits. On the other hand, in-person visits could help patients with pacemakers to cope better with the anxiety linked to their condition and maintain better communication with their doctors than simple remote control of their device status. Therefore, our objective was to analyze the experiences and communication comparing telemonitoring (TM) versus conventional monitoring (CM) of patients with pacemakers. A single-center, controlled, non-randomized, non-blinded clinical trial was designed. Data were collected five years after implantation in a cohort of 89 consecutive patients assigned to two different groups: TM and CM. The 'Generic Short Patient Experiences Questionnaire' (GS-PEQ) was used to assess patients' experiences, and the Healthcare Communication Questionnaire (HCCQ) was used to measure the communication of patients with healthcare professionals. Additionally, an ad-hoc survey including items from the 'Telehealth Patient Satisfaction Survey' and a 'costs survey' was used. After five years, 55 patients completed the study (TM = 21; CM = 34). Participants' mean (±SD) age was 81 (±6.47), and 31% were females. No differences in baseline characteristics between groups were found. The comparative analyses TM versus CM showed some significant differences. According to GS-PEQ, TM users received adequate information about their diagnosis or afflictions (p = .035) and the treatment was better adapted to their situation (p = .009). Both groups reported negative experiences regarding their involvement in their treatment decisions, the waiting time before admission, and perceived a low-benefit. According to HCCQ, the TM group experienced poorer consultation management by the healthcare provider (p = .041). Participants reported positive overall communication experiences. The study provides insights into the experiences and communication in PM monitoring services as well as specific areas where users reported negative experiences such as the consultation management by clinicians. Trial registration: ClinicalTrials.gov NCT02234245.

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Postoperative Complications in the Ahmed Baerveldt Comparison Study During Five Years of Follow-up.

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Postoperative Complications in the Ahmed Baerveldt Comparison Study During Five Years of Follow-up.

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