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Baerveldt Glaucoma Implant versus Ahmed Glaucoma Implant in a One-Year Follow Up, Comparative Study.

ABSTRACT: Aim:To compare clinical outcomes between Ahmed glaucoma implant (AGV-S2 and FP7 models) and Baerveldt-350 glaucoma implant (BGI). Design:Prospective randomized study. Methods and subjects:Eighty-one participants with glaucoma after ocular surgery or secondary glaucoma with persistent and uncontrolled IOP > 21 mmHg were randomized for placement of BGI or AGV models using a standardized surgical technique. The primary outcome was failure, which was defined as IOP >16 mmHg with glaucoma medication, on 2 consecutive study visits. Secondary outcomes were IOP, medication use, visual acuity, complications, and interventions. Results:At one-year follow up, the mean IOP was 14.76±2.5 mmHg in BGI group and 16.57±3.35 mmHg in AGV group (P=0.015). The mean number of glaucoma medications in use was 1.6±0.81 in the BGI group and 3.91±0. 0.28 in the AGV group (P <0.001). There was 1.81 mmHg difference in the mean IOP between participants in both groups with 0.85 SD difference. At 12 months, the failure rate was 11/56 (19.67%) in AGV group and 3/25 (12%) in BGI group (P=0.352). The VA was stable in 77% in the BGI group (P=0.93) versus 80% of patients in AGV group (P=0.88). No significant change was observed in logMAR Snellen VA between both groups (P=0.254). None of the patients lost light perception. Conclusion:Both the Ahmed valve implant and the Baerveldt implant are effective in reducing preoperative IOP and glaucoma medications in patients with refractory glaucoma. This trial cannot give clear clinical proof for valve superiority over the other. The Baerveldt-350 implant can be a good choice for refractory glaucoma cases. Capsular scarring around the plate is considered as the main factor for surgical failure and resistant IOP. Trial registration:The trial was registered with the Research Ethical Committee, Ain Shams University, FWA 000017585 FMASU 21/2017, and registered at Clinical Trial. gov: NCT04215575.

SUBMITTER: Elbaklish KH

PROVIDER: S-EPMC6955622 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Baerveldt Glaucoma Implant versus Ahmed Glaucoma Implant in a One-Year Follow Up, Comparative Study.

Elbaklish Khaled Hamdi KH Saleh Safaa Mohammed SM Gomaa Wael Adel WA

Clinical ophthalmology (Auckland, N.Z.) 20200108

<h4>Aim</h4>To compare clinical outcomes between Ahmed glaucoma implant (AGV-S2 and FP7 models) and Baerveldt-350 glaucoma implant (BGI).<h4>Design</h4>Prospective randomized study.<h4>Methods and subjects</h4>Eighty-one participants with glaucoma after ocular surgery or secondary glaucoma with persistent and uncontrolled IOP > 21 mmHg were randomized for placement of BGI or AGV models using a standardized surgical technique. The primary outcome was failure, which was defined as IOP >16 mmHg wit ...[more]

PMID: 32021066

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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:PurposeIn eyes with a prior failed aqueous shunt (or "tube") requiring additional intraocular pressure (IOP) control, options include angle surgery, cyclodestruction, second tube, tube revision, or tube exchange. We present a case of a same-quadrant tube exchange of a Baerveldt-250 (BGI-250) to BGI-350.ObservationsThe patient is a 71-year-old African American female with severe-stage primary open angle glaucoma of both eyes, and this case focuses on the right eye. This eye had prior cataract surgery with iStent, prior BGI-250 in the anterior chamber (AC), and prior iStent removal with gonioscopy assisted transluminal trabeculotomy (GATT). The visual acuity (VA) was 20/150, and the IOP was 26 mmHg on 3 IOP-lowering medications. The prior superotemporal BGI-250 had its "wings" on top of the superior and lateral rectus muscles and its tube tip in the AC. The implant was removed in its entirety including the superficial and deep layers of its capsule. The new BGI-350 was stented with a 3-0 polypropylene ripcord, ligated with a 7-0 polyglactin suture, and implanted with its wings under the rectus muscles and the tube tip in the sulcus. For early IOP-lowering prior to ligature dissolution, 2 needle stab fenestrations and an additional 7-0 polyglactin wick was used. The capsule from the prior BGI-250 was used as a patch graft for the new BGI-350. The ligature dissolved at postoperative week (POW) 6. By POW8, the IOP was 18 mmHg on 3 IOP-lowering medications and frequent topical steroid, the AC was quiet, and the ripcord was removed. A slow steroid taper finished at postoperative month (POM) 6. By POM 12, the VA was still at baseline 20/150, and the IOP was 14 mmHg on 3 IOP-lowering medications.Conclusions & importancePatients with a prior failed tube requiring additional IOP-lowering can undergo a same-quadrant tube exchange. BGI-350s may offer more IOP-lowering than BGI-250s, but the IOP-lowering achieved in this patient's case could be attributable to differences in postoperative management in addition to endplate size; longer follow-up is needed. A tube exchange offers the opportunity to reposition the tube tip from the AC to the sulcus and to use the prior tube's capsule as a patch graft for the new tube.

Project description:AimTo compare a range of clinical outcome variables (intraocular pressure, glaucoma medications, visual acuity, and complications) between two Ahmed glaucoma valve (AGV) models (S2 and FP7).MethodsThis was a prospective and randomized clinical trial. Fifty-six patients with refractory glaucoma were randomly assigned to be implanted with either a polypropylene (S2) or silicone (FP7) Ahmed glaucoma valve. The primary outcome measure was a surgical success, defined as an IOP ≤ 16 mm Hg (without medication), and guarded success, defined as a controlled IOP ≤ 16 mmHg (with medication). Failure was defined as when the IOP lay outside of the successful range on two consecutive visits (>16 mmHg, despite medication).ResultsMean follow-up period was 398.42 ± 12.34 days (range, 380-420 days) for the S2 group and 401.75 ± 9.78 days (range, 385-420 days) for the FP7 group; these values were not significantly different (P = 0.27). After 12 months of follow-up, the baseline IOP (45.42 mmHg) fell significantly to 16.14 mmHg in the S2 group (p < 0.000); there was also a significant reduction in IOP in the FP7 group (from 44.17 mmHg to 15.18 mmHg in FP7 group, p < 0.000). At the last follow-up examination, the mean IOP in the S2 group was 16.14 ± 3.18 mmHg, while that of the FP7 group was 15.18 ± 2.75 mmHg; there was no significant difference between the two groups with this respect (p = 0.23). The mean number of medications used by patients in the S2 and FP7 groups was 2.92 ± 1.27 and 2.75 ± 1.43, respectively; there was no significant difference between the two groups with this respect (p = 0.32). There was no significant difference between the FP7 and S2 groups with regard to their relative success rate (17.89% [5/28] versus 10.7% [3/28], respectively; p = 0.38).ConclusionOur data show that the S2 and FP7 models of AGV were both effective in lowering IOP and reducing the need for glaucoma medications. Although these two AGV models had similar dimensions, they were constructed from different materials. However, there were no significant clinical differences between the S2 and FP7 AGV groups after 12 months of follow-up. Furthermore, our data indicate that bleb encapsulation was the primary factor responsible for failure rate and the need for glaucoma medication in both the S2 and FP7 groups. Our analysis further indicates that the S2 and FP7 Ahmed valves are associated with a high risk of failure when considered as a first-line therapy for cases experiencing trabeculectomy.Clinical trial registrationNCT04214847.

Project description:IntroductionTo investigate the outcomes of trabeculectomy (TRAB) versus repeat Ahmed glaucoma valve (re-AGV) implantation in eyes with Ahmed glaucoma valve (AGV) failure.MethodsThis quasi-experimental study includes patients with failed AGV implants requiring additional surgical intervention between 2018 and 2022. Patients in the TRAB group underwent a fornix-based procedure with mitomycin C 0.01% injection (0.1 mL). Eyes in the re-AGV group underwent repeat shunt surgery. The choice of the procedure was based on conjunctival condition. The primary outcome measure was surgical success rate based on various intraocular pressure (IOP) targets and percentages of IOP reduction from baseline: IOP ≤ 21 mmHg and 20% reduction (conventional criteria), IOP ≤ 18 and > 20% reduction (criterion A), IOP ≤ 15 and > 25% reduction (criterion B), and IOP ≤ 12 and > 30% reduction (criterion C).ResultsForty-eight eyes of 48 patients were operated and reported herein, consisting of 22 eyes of 22 patients undergoing TRAB and 26 eyes of 26 subjects undergoing re-AGV. No significant difference was observed between the study groups in terms of initial diagnoses, baseline IOP or the number of prior surgeries. The cumulative probability of survival at one year was significantly higher in the trabeculectomy group using the three stricter success definitions. In both study groups, IOP was significantly reduced from baseline at all postoperative visits, and was significantly lower in the TRAB group at all time points beyond one month. At 12 months, 5% of TRAB versus 48% of re-AGV eyes required glaucoma medications (P < 0.001). The rate of complications was comparable between the study groups (P = 0.76) but there was a trend toward a greater need for repeat surgery in the re-AGV group (4 eyes versus nil, P = 0.07).ConclusionsTrabeculectomy can be considered a safe and effective surgical option in eyes with failed AGV leading to significantly lower IOP levels and more favorable success rates than re-AGV in selected patients.

Dataset Information

Baerveldt Glaucoma Implant versus Ahmed Glaucoma Implant in a One-Year Follow Up, Comparative Study.

Publications

Baerveldt Glaucoma Implant versus Ahmed Glaucoma Implant in a One-Year Follow Up, Comparative Study.

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