Mansouri Kaweh, Shaarawy Tarek, Wedrich Andreas, Mermoud André
Hôpital Ophtalmique Jules Gonin, Department of Ophthalmology, University of Lausanne, Switzerland.
J Glaucoma. 2006 Jun;15(3):264-70. doi: 10.1097/01.ijg.0000212211.33265.6d.
To compare the intraocular pressure (IOP) lowering effect and safety of a new rigid, nonabsorbable polymethylmethacrylate implant (PMMA) with the commercially available cylindrical collagen implant used in deep sclerectomy procedure.
Nonpenetrating deep sclerectomy was performed on all patients. Patients were randomly assigned to receive either a PMMA implant or a collagen implant.
The trial involved 60 patients (60 eyes) with medically uncontrolled primary and secondary open-angle glaucoma who were randomized to receive either a PMMA implant (30 eyes) or the collagen implant (30 eyes). The patients were examined before and after the operation 1 day before surgery and at day 1; weeks 1, 2 and 3; and months 1, 2, 3, 6, 9, 12, 18, 24, and 30. At each visit, the following examinations were performed: slit lamp examination, tonometry, visual acuity, and fundoscopy.
The mean follow-up period was 20.4 (SD 12.4) months (PMMA) and 15.1 (SD 7.7) months (collagen) (P=NS). The mean preoperative IOP was 21.4 (SD 7.1) mm Hg (PMMA) and 21.0 mm Hg (SD 5.4) (collagen). The mean postoperative IOP was 7.4 (SD 4.5) mm Hg (PMMA) and 5.4 (SD 4.4) mm Hg (collagen) at day 1 (P=NS), 15.7 (SD 5.0) mm Hg (PMMA) and 14.7 (SD 5.0) mm Hg (collagen) at month 1 (P=NS), and 13.8 (SD 4.8) mm Hg (PMMA) and 13.3 (SD 2.4) mm Hg (collagen) at month 12 (P=NS). Seven patients had perforations of the trabeculo-Descemet membrane and were excluded from the analysis. At the last follow-up visit, 42% of PMMA patients and 44% of collagen patients achieved an IOP of 21 mm Hg or less without medication (P=NS). The number of medications was reduced from 2.4 (SD 1.0) to 0.6 (SD 0.6) (P<0.001) in the PMMA group, and from 2.4 (SD 1.1) to 0.7 (SD 0.8) (P<0.001) in the collagen group. There were no significant differences between the 2 groups in postoperative and transient complications.
The new PMMA implant offered success and complication rates equal to those of the collagen implant. The new PMMA implant could serve as a low-cost alternative to the collagen implant and render the use of deep sclerectomy with an implant affordable for settings with limited financial resources.
比较一种新型硬质、不可吸收的聚甲基丙烯酸甲酯植入物（PMMA）与用于深层巩膜切除术的市售圆柱形胶原植入物降低眼压（IOP）的效果和安全性。
对所有患者进行非穿透性深层巩膜切除术。患者被随机分配接受PMMA植入物或胶原植入物。
该试验纳入了60例（60只眼）药物治疗无法控制的原发性和继发性开角型青光眼患者，随机分为接受PMMA植入物组（30只眼）和胶原植入物组（30只眼）。在手术前1天、术后第1天；第1、2、3周；以及第1、2、3、6、9、12、18、24和30个月对患者进行检查。每次就诊时，进行以下检查：裂隙灯检查、眼压测量、视力检查和眼底镜检查。
平均随访期为20.4（标准差12.4）个月（PMMA组）和15.1（标准差7.7）个月（胶原组）（P=无显著性差异）。术前平均眼压为21.4（标准差7.1）mmHg（PMMA组）和21.0 mmHg（标准差5.4）（胶原组）。术后第1天平均眼压为7.4（标准差4.5）mmHg（PMMA组）和5.4（标准差4.4）mmHg（胶原组）（P=无显著性差异），第1个月为15.7（标准差5.0）mmHg（PMMA组）和14.7（标准差5.0）mmHg（胶原组）（P=无显著性差异），第12个月为13.8（标准差4.8）mmHg（PMMA组）和13.3（标准差2.4）mmHg（胶原组）（P=无显著性差异）。7例患者小梁-Descemet膜穿孔，被排除在分析之外。在最后一次随访时，42%的PMMA组患者和44%的胶原组患者在未用药情况下眼压达到或低于21 mmHg（P=无显著性差异）。PMMA组药物数量从2.4（标准差1.0）减少到0.6（标准差0.6）（P<0.001），胶原组从2.4（标准差1.1）减少到0.7（标准差0.8）（P<0.001）。两组术后和短暂并发症无显著差异。
新型PMMA植入物的成功率和并发症发生率与胶原植入物相当。新型PMMA植入物可作为胶原植入物的低成本替代品，使有限经济资源环境下使用植入物的深层巩膜切除术变得经济可行。
