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

Abstract

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.

Nonpenetrating Glaucoma Surgery: Meta-analysis of Recent Results

“…25 The rate of postoperative 5-fluorouracil (5-FU) injection ranged between 4.6% and 43.6%. 20,21,23,24 In reports of DS with implant, the rate of goniopuncture ranged between 5.5% and 81%, 28,29,31,[33][34][35][37][38][39] with up to 45% (9 mm Hg) reduction in IOP, 34 and the rate of postoperative 5-FU injection ranged between 7% and 56%. 34,35,[37][38][39] The rate of goniopuncture after DS with antimetabolite could be as high as 46.9%, 37 and the rate of postoperative 5-FU injection as high as 28.9% (Table 2).…”

“…10, The percentage of cases achieving at least 21 mm Hg was 48.6% after primary DS (DS without any implant or antimetabolite), 10,[19][20][21][22][23][24][25] 68.7% after DS with implant, [26][27][28][29][30][31][32][33][34][35][36][37][38][39] and 67.1% after DS with antimetabolite (with/ without implant) (Table 1). 21,[36][37][38] With lower set IOP targets, success ranged between 35% and 86% (Table 5).…”

“…[26][27][28][29][30][31][32][33][34][35][36][37][38][39] After DS with antimetabolite (4 studies), the percentage achieving at least 21 mm Hg was 67.1% at 52 months (Table 1). 21,[36][37][38] Among reports of DS with implant or antimetabolite, visual field parameters were available in only 1 study.…”

Migration of reticulated hyaluronic acid implant [SK-GEL] following deep sclerectomy

“…Dahan et al [8] described migration of an unsutured T-flux implant (nonabsorbable) in NPDS to the anterior chamber (A/C); the implant was removed without sequelae. Wevill et al [9] reported migration of chromic suture material used as an implant in NPDS to the anterior chamber after a blunt trauma to the eye. The implant was removed because of corneal edema and the anterior chamber reaction induced by its presence.…”

A composite material used as a membrane for ophthalmology applications

“…The requirements for any material used for ophthalmologic implants are in general sense the same; the material must be biocompatible, biostable and should have the microstructure suitable for fluid transport [4,5]. Such implants are to date made of natural polymers, e.g.…”