A pilot study of deep sclerectomy with implantation of chromic suture material as a collagen implant: medium-term results.

AIMS: A pilot study of the safety and efficacy of deep sclerectomy with a chromic suture implant (DSCI) for open angle glaucoma.

METHODS

This prospective trial involved 23 eyes of 16 consecutive patients with uncontrolled open angle glaucoma. The DSCI procedure involved radial suturing of a 2 mm piece of 1/0 chromic suture as an implant. Intraocular pressure (IOP) measurements and eye examinations were performed preoperatively and regularly postoperatively for up to 66 months.

RESULTS

The mean follow-up period was 36.3 (SD 19.9) months. The mean preoperative IOP was 26.3 (SD 8.5) mmHg. The mean postoperative IOP was 14.1 (SD 2.8) mmHg at month 12, and 16.5 (SD 2.3) mmHg at 36 months. Complete success rate, defined as an IOP lower than 21 mmHg without medication was 77% of eyes at 36 months. Qualified success rate, defined as an IOP lower than 21 mmHg with medication, was 100% at 36 months. Paired t-test and Wilcoxon test analysis of preoperative vs postoperative IOP at 36 months indicated a significant reduction in IOP. Intraoperative complications included rupture of the trabecular meshwork in seven eyes. Exclusion of these patients from the results analysis revealed a mean follow-up of 37.1 months (SD 9), preoperative mean IOP was 25.9 mmHg (SD 4.1), 12-month mean IOP was 13.4 mmHg (SD 2.8), and 36-month mean IOP 16.6 mmHg (SD 2.1). Early postoperative complications included hyphaema in two eyes and dislocation of implant in one eye. One eye developed a central retinal vein occlusion and cataract progression occurred in one eye. The mean postoperative duration of use of topical dexamethasone was 5.4 months (SD 2).

CONCLUSIONS

DSCI using a chromic suture implant provides good control of IOP at medium-term follow-up with few postoperative complications. Prolonged use of postoperative anti-inflammatory medication was necessary.