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Barbara Giambene, Fernando G. Galassi; T-Flux NV Versus SKGEL Implants In Deep Sclerectomy In Open-Angle Glaucoma: A 5-Year Study. Invest. Ophthalmol. Vis. Sci. 2012;53(14):3738.
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to compare the efficacy of T-Flux NV and SKGEL implants in deep sclerectomy at 5 years.
in this retrospective analysis 147 eyes of 147 patients with medically uncontrolled open-angle glaucoma, matched for age, gender, disease severity and duration, preoperative intraocular pressure (IOP) and topical medications, and treated with deep sclerectomy with T-Flux NV (50 eyes) or SKGEL (97 eyes) implant, were included. The following variables were recorded: IOP, mean deviation (MD) and pattern standard deviation (PSD) on Humphrey 24-2 visual field (VF) testing, number of antiglaucoma medications and Nd:YAG laser goniopuncture. Complete and qualified success were defined as IOP ≤16 mmHg without and with or without hypotensive medications, respectively.
after a follow-up of 5 years the mean IOP decreased from 23.52 ±0.50 mmHg to 11.98 ±0.27 mmHg with T-Flux NV and from 20.98 ±0.53 mmHg to 12.94 ±0.20 mmHg with SKGEL (p<0.001 for both comparisons). The final IOP was lower with T-Flux NV than with SKGEL (p=0.006). Complete success was achieved in 84% (n=42) with T-Flux NV and 64.9% (n=63) with SKGEL (p=0.026), qualified success rate in 100% (n=50) with T-Flux NV and 89.7% (n=87) with SKGEL (p=0.003). Antiglaucoma medications decreased from 3.12 ±0.09 to 0.32 ±0.09 with T-Flux NV (-2.80 ±0.11) and from 2.70 ±0.06 to 0.40 ±0.06 with SKGEL (-2.30 ±0.09) (p<0.001). Goniopuncture was done in 34.00% of T-Flux NV and 23.71% of SKGEL (p=0.258). The procedure was performed earlier in the T-Flux NV group than in the SKGEL one (1.82 ±0.40 vs 6.74 ±1.93 months, p=0.038). VF testing revealed stable MD and PSD in both groups at the end of the follow-up (p>0.05).
the efficacy of deep sclerectomy on IOP control and VF stability is valuable with both T-Flux NV and SKGEL implants. T-Flux implant seems to a grant higher IOP reduction and a reduced number of postoperative antiglaucoma medications in a 5-year follow-up.
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