Baerveldt Glaucoma Implant Group Research Articles

Ahmed and Baerveldt Glaucoma Drainage Devices in Childhood Glaucoma: A Meta-Analysis.

The effectiveness of Ahmed glaucoma valve (AGV) and Baerveldt glaucoma implant (BGI) was comparable in the management of childhood glaucoma over the long term despite initial better success rate with BGI. There were higher tube block and retraction rates in the BGI group and higher tube exposure rates in the AGV group. To evaluate the outcomes and safety of AGV and BGI in childhood glaucoma. We performed a systematic literature review of publications from 1990 to 2022 in PubMed, EMBASE, ClinicalTrials.gov, Ovid MEDLINE, Cochrane CENTRAL, and google scholar for studies evaluating AGV and BGI in childhood glaucoma. Primary outcome measures were intraocular pressure (IOP) reduction and glaucoma medication reduction. The secondary outcome measures were the success rates and incidence of postoperative complications. We conducted a meta-analysis using a random effects model. Thirty-two studies met the inclusion criteria. A total of 1480 eyes were included. The mean IOP reduction was 15.08 mm Hg ( P < 0.00001) for AGV and 14.62 ( P < 0.00001) for the BGI group. The mean difference between pre and postoperative glaucoma medications was 1 ( P < 0.00001) fewer medications in the AGV group and 0.95 ( P < 0.0001) fewer medications in the BGI group. There was a lower success rate in the AGV versus BGI groups at 2 years [63% vs 83%, respectively ( P < 0.0001) and 3 years (43% vs 79%, respectively ( P < 0.0001)]; however, the success was higher for AGV at 5 years (63% vs 56% in the BGI group, P < 0.001). The incidence of postoperative complications was comparable in the AGV and BGI groups, with rates of 28% and 27%, respectively. The IOP and glaucoma medication reduction, success rates, and incidence of postoperative complications were comparable in Ahmed and Baerveldt groups. Most literature comes from retrospective low-quality studies on refractory childhood glaucoma. Further larger cohort studies are needed.

Comparison of the Ahmed and Baerveldt Glaucoma Drainage Implants in the Treatment of Primary Congenital Glaucoma.

To compare the outcomes of the Ahmed glaucoma valve (AGV) (New World Medical, Inc) with the Baerveldt glaucoma implant (BGI) (Johnson & Johnson Vision) in primary congenital glaucoma (PCG). This was a retrospective review of children with PCG who underwent AGV or BGI implantation with a minimum follow-up of 6 months. Main outcome measures were intraocular pressure (IOP), the number of glaucoma medications, success rate, complications, and surgical revisions. The study included 153 eyes of 86 patients (120 eyes in the AGV group and 33 eyes in the BGI group), and the mean follow-up period was 58.7 ± 6.9 months in the AGV group and 58.5 ± 5.0 months in the BGI group. At baseline, IOP was lower in the AGV group (33 ± 6.3 vs 36.4 ± 6.1 months; P = .004) and the number of glaucoma medications was comparable between groups (3.4 ± 0.9 vs 3.6 ± 0.5 medication; P = .183). At 5 years, the mean IOP (18.4 ± 5.0 vs 16.3 ± 2.5 mm Hg; P = .004) and number of glaucoma medications (2.1 ± 1.3 vs 1.0 ± 1.0 medication; P = .001) were significantly less in the BGI group. Furthermore, the surgical success was 53.4% in the AGV group and 78.8% in the BGI group (P = .013). Both the AGV and BGI were successful in providing adequate IOP control in patients with PCG. Long-term follow-up showed that the BGI was associated with a lower IOP, fewer glaucoma medications, and a higher success rate. [J Pediatr Ophthalmol Strabismus. 2023;60(6):448-454.].

Primary baerveldt versus trabeculectomy study after 5years of follow-up.

PurposeAlthough the Baerveldt glaucoma implant (BGI) initially was reserved for refractory glaucoma, its role in the surgical management of glaucoma has shifted towards a primary treatment choice. We performed a randomized prospective study to compare BGI surgery and trabeculectomy (TE) in patients without previous ocular surgery.MethodsWe included 119 glaucoma patients without previous ocular surgery. One eye of each subject was randomized to either a BGI or TE. Follow‐up visits were at 1 day, 2 weeks, 6 weeks, 3 months, 6 months and 1, 2, 3, 4 and 5 years postoperatively. Primary outcomes were intraocular pressure (IOP) and failure rate. Secondary outcomes were medication, anterior chamber laser flare value and complications.ResultsAfter 5 years, an IOP of 12.7 ± 3.9 mmHg (mean ± SD) was achieved in the TE group and 12.9 ± 3.9 mmHg in the BGI group. We found no statistically significant difference in failure rate between the groups (p = 0.72). More BGI patients needed additional medication to control their IOP (85%; 1.9 ± 1.2 types of glaucoma medication) compared to the TE patients (57%; 0.5 ± 0.9 types of glaucoma medication). Diplopia was significantly more present in the BGI group than in the TE group (27% versus 4%; p < 0.001). The self‐limiting complication rate was similar in both groups.ConclusionsOur study demonstrates that, in the long term, the final IOP and failure rate are similar after TE and BGI surgery. However, the need for additional medication after BGI surgery is higher than after TE. Also, the increased risk of developing diplopia after BGI surgery must be taken into consideration.

Motility Changes and Diplopia After Baerveldt Glaucoma Drainage Device Implantation or After Trabeculectomy.

PurposeThe purpose of this study was to quantify any diplopia and motility changes after the implantation of a Baerveldt glaucoma implant (BGI) or after trabeculectomy (TE).MethodsWe analyzed 51 patients with a BGI and 52 patients with a TE from a prospective cohort study. To quantify any diplopia, we asked patients about the presence of diplopia at 1 year after surgery. To quantify any ocular motility changes, we measured ductions in eight gaze directions, the patients' ocular alignment and their fusion range before and 1 year after surgery.ResultsIn the BGI group, 14 patients (28%) experienced diplopia compared with one patient (2%) in the TE group (P < 0.001). Duction changes were more commonly observed in the BGI group (35%) than in the TE group (19%). In the BGI group, ductions were mostly restricted in elevation (13%; P < 0.001), in abduction (13%), in elevation in 25° adduction (13%; P = 0.044), and in elevation in 25° abduction (25%; P < 0.001). In 32% of the patients, their near horizontal ocular alignment shifted, notably in exodirection (P = 0.04). The fusion range decreased significantly in the horizontal direction (−12.6° ± 10.3°, mean ± standard deviation; P = 0.01).ConclusionsBGI surgery was significantly associated with postoperative diplopia and impaired eye motility (reduced ductions), mostly present in abduction, elevation, elevation in 25° adduction, and elevation in 25° abduction. Even without impaired ductions, diplopia could come about.Translational RelevanceBy studying diplopia across glaucoma patients prospectively with diplopia questionnaires and extensive orthoptic measurements, we gain better insight into its occurrence.

Reversible Venting Stitch for Fenestrating Valve-less Glaucoma Shunts.

The purpose of this is to describe a venting stitch modification for valveless glaucoma aqueous shunts and characterize early postoperative intraocular pressure (IOP) and glaucoma medication use following the modification. Retrospective chart review of 61 sequential patients undergoing Baerveldt glaucoma implant (BGI)-350 implantation at the Doheny Eye Institute. Twenty-four patients received a glaucoma shunt with venting stitch modification (modified BGI) and 37 patients received an unmodified shunt (BGI-only). IOP, number of glaucoma medications, and number of hypotony cases (intraocular pressure ≤5 mm Hg) were compared between the groups. T-tests were used for statistical analysis. At postoperative-day 1, mean IOP was significantly lower compared with preoperatively in the modified BGI group (14 mm Hg; reduced by 51%; P<0.0001) but not the BGI-only group (27 mm Hg; P=0.06). IOP difference between groups persisted till immediately before tube opening (P=0.005) and fewer IOP-lowering medications needed in the modified BGI group (P<0.0001). One case (4.2%) of postoperative hypotony was encountered with BGI modification, which resolved after the stitch was removed in clinic. The venting stitch valveless shunt modification allows for effective, reliable, and safe control of early postoperative IOP.

Ahmed Versus Baerveldt Glaucoma Drainage Implantation in Patients With Markedly Elevated Intraocular Pressure (≥30 mm Hg)

Glaucoma patients with markedly elevated intraocular pressure (IOP) are at risk for developing severe hypotony-related complications. The goal of this study was to compare the surgical outcomes of the Ahmed Glaucoma Valve (AGV) and the Baerveldt Glaucoma Implant (BGI) in this patient population. Patients with preoperative IOP≥30 mm Hg were included. Outcome measures were: (1) surgical failure (IOP>21 mm Hg or <30% reduction from baseline or IOP≤5 mm Hg on 2 consecutive follow-up visits after 3 mo, or additional glaucoma surgery, or loss of light perception) and (2) surgical complications. A total of 75 patients were included: 37 in the AGV group and 38 in the BGI group. The mean±SD follow-up was 2.3±1.6 years for the AGV group and 2.4±1.7 years for the BGI group (P=0.643). Mean preoperative IOP was 38.7±6.5 mm Hg for the AGV group and 40.8±7.6 mm Hg for the BGI group. At the last follow-up, 10 (27.0%) patients failed in the AGV group compared with 6 (15.8%) patients in the BGI group (P=0.379). The BGI group had higher rate of flat or shallow anterior chamber (n=4, 10%) compared with the AGV group (n=0, 0%) (P=0.043). Failure rates of AGV and BGI in patients with IOP≥30 mm Hg were comparable. There were more early hypotony-related complications in the BGI group; however, none were vision threatening. Both glaucoma drainage implants were effective in treating patients with uncontrolled glaucoma in an emergency setting.

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

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.

Three-year Treatment Outcomes in the Ahmed Baerveldt Comparison Study

To compare 3-year outcomes and complications of the Ahmed FP7 Glaucoma Valve (AGV) (New World Medical, Cucamonga, CA) and the Baerveldt Glaucoma Implant (BGI) 101-350 (Abbott Medical Optics, Abbott Park, IL) for the treatment of refractory glaucoma. Multicenter, randomized, controlled clinical trial. A total of 276 patients: 143 in the AGV group and 133 in the BGI group. Patients aged 18 to 85 years with refractory glaucoma and intraocular pressures (IOPs) ≥ 18 mmHg in whom an aqueous shunt was planned were randomized to an AGV or a BGI. The IOP, visual acuity (VA), supplemental medical therapy, complications, and failure (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). At 3 years, IOP (mean ± standard deviation) was 14.3 ± ± 4.7 mmHg (AGV group) and 13.1 ± 4.5 mmHg (BGI group) (P = 0.086) on 2.0 ± 1.4 and 1.5 ± 1.4 glaucoma medications, respectively (P = 0.020). The cumulative probabilities of failure were 31.3% (standard error [SE], 4.0%) (AGV) and 32.3% (4.2%) (BGI) (P = 0.99). Postoperative complications associated with reoperation or vision loss of >2 Snellen lines occurred in 24 patients (22%) (AGV) and 38 patients (36%) (BGI) (P = 0.035). The mean change in the logarithm of the minimum angle of resolution VA at 3 years was similar (AGV: 0.21 ± 0.88, BGI: 0.26 ± 0.74) in the 2 treatment groups at 3 years (P = 0.66). The cumulative proportion of patients (SE) undergoing reoperation for glaucoma before the 3-year postoperative time point was 14.5% (3.0%) in the AGV group compared with 7.6% (2.4%) in the BGI group (P = 0.053, log rank). The relative risk of reoperation for glaucoma in the AGV group was 2.1 times that of the BGI group (95% confidence interval, 1.0-4.8; P = 0.045, Cox proportional hazards regression). Implantation of the AGV was associated with the need for significantly greater adjunctive medication to achieve equal success relative to implantation of the BGI and resulted in a greater relative risk of reoperation for glaucoma. More subjects experienced serious postoperative complications in the BGI group than in the AGV group.

Treatment Outcomes in the Ahmed Baerveldt Comparison Study after 1 Year of Follow-up

To 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. Multicenter, randomized, controlled clinical trial. Two hundred seventy-six patients, including 143 in the AGV group and 133 in the BGI group. Patients 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. The 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. Preoperative 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). Although 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.