FLUOROPHOTOMETRIC STUDY OF THE EFFECT OF the GLAUKOS TRABECULAR MICRO-BYPASS STENT ON AQUEOUS HUMOR DYNAMICS.
|Autores:||Fernández-Barrientos Y, García-Feijoó J, Martinez de la Casa JM, Pablo LE, Fernández-Pérez C, García Sánchez J|
|Títuto Revista:||Invest Ophthalmol Vis Sci.|
|Colaboradores:||Grupo de Diseño y Evaluació de Productos Biomateriales Oftálmicos (DEPBO)|
|Centro:||IIORC - UCM|
Purpose: To evaluate the changes in aqueous humor dynamics and the efficacy and safety of the iStent(R) in combination with cataract surgery. Methods: Prospective, randomized, clinical study in patients with open-angle glaucoma or ocular hypertension, undergoing cataract surgery. Aqueous flow (F) and trabecular outflow facility (CT) was measured by fluorophotometry preoperatively and at months 1, 6 and 12 in both groups. Results: Thirty-three eyes of 33 patients were randomized to either two stents and cataract surgery (n=17, Group 1) or cataract surgery alone (n=16, Group 2). Preoperatively, F and CT were similar in Groups 1 and 2 (1.78 +/- 0.44 and 1.74 +/- 0.82 microl/min, p=0.18; 0.12 +/- 0.03 and 0.13 +/- 0.06 microl/min/mmHg, p=0.71, respectively). Postoperatively, there were no changes of note in F, however, CT increased in both groups. At one year, CT was 0.45+/-0.27 microl/min/mmHg in Group 1 and 0.19+/-0.05 microl/min/mmHg in Group 2 (p=0.02), which represented increases of 275% and 46%, respectively. Mean IOP reduction was also greater in Group 1 than in Group 2 (6.6 +/- 3.0 vs. 3.9 +/- 2.7 mmHg; p=0.002). The mean number of medications was significantly lower in Group 1 vs. Group 2 (0.0 vs. 0.7 +/- 1.0, respectively; p=0.007). Conclusions: Compared with cataract surgery alone, implantation of the iStent(R) concomitant with cataract extraction significantly increased the trabecular outflow facility, achieved IOP reduction, and reduced the number of medications at one year. Longer follow-up is needed to assess the long-term effect on outflow facility.