T-Flux Implant versus Healon GV® in Deep Sclerectomy

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Abstract

Purpose

To compare the efficacy and safety of T-Flux implant versus Healon GV® in deep sclerectomy.

Methods

Randomized prospective trial of 23 eyes of 20 patients with medically uncontrolled open angle glaucoma over a period of 24 months, who underwent deep sclerectomy with either Healon GV® or T-Flux implant.

Results

Mean postoperative intraocular pressure was 13.2 ± 3.0 mm Hg with T-Flux implant (group 1) and 12.2 ± 3.5 mm Hg with Healon GV® (group 2), with a pressure reduction of 53.0% in group 1 (13.2 mm Hg vs. 28.1 mm Hg) and of 48.1% in group 2 (12.2 mm Hg vs. 23.5 mm Hg). Qualified and complete successes were 100% and 95.4% respectively. Pressures equal to or less than 15 mm Hg were 81.8% in group 1 and 90.9% in group 2 with or without treatment, and 63.6% in group 1 and 81.8% in group 2 without treatment. The number of glaucoma treatments dropped from 2.5 ± 0.9 to 0.4 ± 0.7 in group 1 and from 2.2 ± 1.0 to 0.2 ± 0.4 in group 2. The goniopuncture rate was 63.6% in group 1 and 36.4% in group 2, with a mean pressure drop of 6.1 ± 3.9 mm Hg and 3.25 ± 1.2 mm Hg respectively. Overall, slit-lamp diagnosed surgery-related complications included positive Seidel (13.6%), hyphaema (22.7%), choroidal detachment, and iris incarceration (4.5% each). At 2 years, ultrasound biomicroscopy showed mainly low reflective (40.1%) and flattened (36.4%) blebs. Principally latter ones were associated with the need for adjunctive treatment. A hypoechoic area in the suprachoroidal space was seen in at least 59.1% of eyes at 2 years and was not associated with lower intraocular pressure.

Conclusion

Deep sclerectomy is an effective and safe surgery. However, longer follow up and larger study groups are required to assess the additional benefit of nonabsorbable implants.

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