Deep sclerectomy with a nonabsorbable implant (T-Flux): preliminary results.

Background: Deep sclerectomy is one of the two main types of nonpenetrating surgical methods of treating open-angle glaucoma. We aimed to determine, in a prospective study, the efficacy, success rate and complications of deep sclerectomy with implantation of a nonabsorbable drain made of highly hydrophilic acrylic (T-Flux).

Methods: Twenty-five patients (25 eyes) with medically uncontrolled open-angle glaucoma were treated by deep sclerectomy with implantation of the T-Flux drain. We determined the rates of intraocular pressure (IOP) reduction, surgical success (four categories) and complications. To evaluate the efficacy of this new implant in detail, we compared the success rates with those in a group of patients matched for age, sex, diagnosis, preoperative IOP, number of preoperative antiglaucoma medications and previous ocular surgery who underwent successful viscocanalostomy.

Results: For two eyes in the deep-sclerectomy group, surgery was converted to standard trabeculectomy owing to perforation of the trabeculo-Descemet's membrane during dissection of the corneal stroma. The following results apply to the remaining 23 eyes. After a mean follow-up period of 16.21 (standard deviation [SD] 3.93) months, the mean IOP had fallen from 26.26 (SD 4.3) mm Hg preoperatively to 17.60 (SD 4.35) mm Hg at the last postoperative visit (p = 0.000). The rate of complete success (IOP < 21 mm Hg without medication) was 86.9% at 1 month, 56.5% at 12 months and 39.1% at the last visit. The rates of qualified success (IOP < 21 mm Hg with or without medication) were 95.6%, 91.3% and 82.6%, respectively. No postoperative complications of the type that might occur after trabeculectomy were observed. Three eyes with an insufficient reduction in IOP underwent goniopuncture with a neodymium:YAG laser. Statistical analysis of the success rates revealed that deep sclerectomy with T-Flux implantation was comparable to viscocanalostomy at all postoperative visits (p > 0.05).

Interpretation: A statistically significant drop of IOP with few postoperative complications over the short term was achieved with deep sclerectomy and T-Flux implantation. The success rates were comparable to, and not significantly better than, those of viscocanalostomy.