Abstract
Purpose :
To compare postoperative use of novel 1.5% dexamethasone nanoparticles (DexNP) eye drops after trabeculectomy with Mitomycin C, MMC, and Maxidex®. Can dexNP eye drops replace MMC?
Methods :
A randomized double masked clinical trial included 25 patients undergoing primary trabeculectomy for poorly controlled primary open angle glaucoma. The study group included 15 patients treated with DexNP eye drops QID postoperatively compared to 10 patients in the control group treated with MMC intraoperatively and Maxidex® x6/day postoperatively. The drops were tapered over 8 weeks. The main outcome measure was intraocular pressure (IOP). Secondary outcome measure included glaucoma medications, success rate (IOP <=15 mmHg) and complications.
Results :
Study and control group showed similar postoperative course and reduction in IOP. IOP in the DexNP and control group was 25.3 mmHg and 24.4 mmHg, respectively at baseline and was reduced to 15.4 mmHg and 12.7 mmHg at 3 months and 14.0 mmHg and 13.4 mmHg at 12 months. The IOP reduction was 11.3 mmHg in the study group (p=0.0001) and 11.0 mmHg in the control group (p=0.0018) at 12 months. The success rate was 75% in both groups at 12 months. The success rate was not significantly different in the two groups over the 12 month period (p=0.99). There was no significant difference in the use of anti-glaucoma medications postoperatively or in the rate of complications.
Conclusions :
DexNP eye drops are effective postoperative treatment following trabeculectomy. DexNP are potent anti-inflammatory and anti-fibroblast agents that may offer an alternative to Mitomycin C in glaucoma surgery.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.