Gold Micro-Shunt Implants Versus Ahmed Glaucoma Valve: Long-term Outcomes of a Prospective Randomized Clinical Trial.
Skaat Alon, Sagiv Oded, Kinori Michael, Ben Simon Guy J, Goldenfeld Modi, Melamed Shlomo
AI Summary
This study found that Ahmed Glaucoma Valves and two sizes of Gold Micro-Shunts had similar long-term success, IOP reduction, and medication needs for refractory glaucoma.
Abstract
Purpose
To compare long-term outcomes of Ahmed glaucoma valve (AGV), 24 μm Gold Micro-Shunt (GMS), and 48 μm GMS implantation for treatment of refractory glaucoma.
Patients and methods: This was a 3-armed randomized interventional prospective clinical trial. Within an institutional setting, 29 adults (29 eyes) with refractory glaucoma [mean baseline intraocular pressure (IOP) ≥ 22 mm Hg on maximal medication, status post at least 1 failed trabeculectomy, defined visual field defect, and without recent glaucoma-related surgery] were randomly assigned to AGV, 24 μm GMS, or 48 μm GMS implantation. Exclusion criteria included uveitic, traumatic, or neovascular glaucoma. The 3 groups were comparatively evaluated preoperatively and 1, 2, 3, and 5 years postoperatively for IOP and numbers of glaucoma medications needed. Main outcome measures were implant survival rates. Results of the 24 and 48 μm GMS groups were also compared separately.
Results
In all groups the final IOP (in mm Hg) was significantly lower than the preoperative IOP (17.3 ± 2.6 vs. 33.5 ± 6.7, P=0.004; 17.8 ± 2.4 vs. 25.7 ± 0.7, P=0.0001; and 19.6 ± 5.2 vs. 35.6 ± 2.2, P=0.0001 in the AGV, 24 μm GMS, and 48 μm GMS groups, respectively). Differences between initial and final mean numbers of medications were not significant. Cumulative probabilities of success at 5 years were 77.8%, 77.8%, and 72.7%, respectively.
Conclusions
During long-term follow-up, success rates in the 2 GMS groups and the AGV group were similar. Likewise, IOP reduction and the need for continued glaucoma medical therapy remained high and were similar for all devices.
MeSH Terms
Shields Classification
Key Concepts6
In a 3-armed randomized interventional prospective clinical trial of 29 adults (29 eyes) with refractory glaucoma, the final intraocular pressure (IOP) in the Ahmed Glaucoma Valve (AGV) group was significantly lower than the preoperative IOP (17.3 2.6 mm Hg vs. 33.5 6.7 mm Hg, P=0.004).
In a 3-armed randomized interventional prospective clinical trial of 29 adults (29 eyes) with refractory glaucoma, the final intraocular pressure (IOP) in the 24 m Gold Micro-Shunt (GMS) group was significantly lower than the preoperative IOP (17.8 2.4 mm Hg vs. 25.7 0.7 mm Hg, P=0.0001).
In a 3-armed randomized interventional prospective clinical trial of 29 adults (29 eyes) with refractory glaucoma, the final intraocular pressure (IOP) in the 48 m Gold Micro-Shunt (GMS) group was significantly lower than the preoperative IOP (19.6 5.2 mm Hg vs. 35.6 2.2 mm Hg, P=0.0001).
In a 3-armed randomized interventional prospective clinical trial of 29 adults (29 eyes) with refractory glaucoma, the cumulative probabilities of success at 5 years were 77.8% for the Ahmed Glaucoma Valve (AGV) group, 77.8% for the 24 m Gold Micro-Shunt (GMS) group, and 72.7% for the 48 m GMS group.
During long-term follow-up in a 3-armed randomized interventional prospective clinical trial of 29 adults (29 eyes) with refractory glaucoma, success rates in the 2 Gold Micro-Shunt (GMS) groups (24 m and 48 m) and the Ahmed Glaucoma Valve (AGV) group were similar.
During long-term follow-up in a 3-armed randomized interventional prospective clinical trial of 29 adults (29 eyes) with refractory glaucoma, intraocular pressure (IOP) reduction and the need for continued glaucoma medical therapy were similar for the Ahmed Glaucoma Valve (AGV), 24 m Gold Micro-Shunt (GMS), and 48 m GMS devices.
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