[Preliminary investigation on the safety and efficacy of Trabectome].

OBJECTIVE

To evaluate the safety and efficacy of ab interno trabeculectomy (Trabectome) surgery in Chinese open angle glaucoma patients.

METHODS

Prospective non-comparative case series study. A total of 41 cases (34 primary open angle glaucoma patients, 3 developmental glaucoma patients and 4 pigmentary glaucoma patients) were included in the study. All the cases underwent Trabectome, including 9 cases combined with phacoemulsification cataract extraction. Major outcomes include intraocular pressure (IOP), number of glaucoma medications, secondary glaucoma surgery and postoperative complications. Criteria for successful operation were defined as IOP ≤ 21 mmHg (1 mmHg = 0.133 kPa), at least 20% IOP reduction in any two consecutive visits after 3 months with or without IOP-lowering drugs and no additional glaucoma surgery. IOP and number of glaucoma medications were compared to baseline using Wilcoxon signed-rank test with Bonferroni correction. Kaplan-Meier analysis was performed to analyze the success rate of surgery.

RESULTS

In the all 41 patients, 21 cases (51.2%) were followed up for up to 12 months. IOP was reduced from (22.5 ± 8.1) mmHg to (17.6 ± 6.4) mmHg (P = 0.02), meanwhile number of glaucoma medications was reduced from 2.0 ± 0.9 to 1.2 ± 0.9 (P = 0.02) at 12 months. The success rate at one year was 85% and 4 cases required additional glaucoma surgery.

CONCLUSIONS

Trabectome has many advantages, such as shorter surgery time, simple post-operative care, less intraoperative and postoperative complications and clear IOP-lowering effect. But it slong-term efficacy is still need a large sample, long-term follow-up to verify.