This article is more than 5 years old. Information may no longer be current.
Filtration device, trabeculectomy yield similar outcomes
Click Here to Manage Email Alerts
A glaucoma filtration device and trabeculectomy yielded similar visual and clinical outcomes at 2 years, according to a study.
Mean IOP, medication use and 2-year success rates were similar after implantation of the Ex-Press glaucoma filtration device (Alcon) and trabeculectomy.
“We found that the efficacy was similar between the two groups, the Ex-Press device vs. the trabeculectomy group. In other words, the intraocular pressure and surgical success were similar after both procedures,” Peter A. Netland, MD, the corresponding author, said in an interview with Ocular Surgery News. “The Ex-Press implant, however, was associated with fewer postoperative complications, more rapid visual recovery and less variance of intraocular pressure during the early postoperative period.”
The study was published in the American Journal of Ophthalmology.
Patients and methods
The prospective randomized multicenter trial included 120 eyes of 120 patients; 59 eyes received an Ex-Press shunt placed under a partial-thickness scleral flap and 61 eyes underwent trabeculectomy.
Patients in both groups were followed for 2 years after surgery.
The main outcome measures were mean IOP, medication use and surgical success, defined as IOP of 5 mm Hg to 18 mm Hg with or without medications and without additional glaucoma surgery.
Secondary outcome metrics were logMAR visual acuity, IOP 2 weeks after surgery and surgical complications.
Netland described how investigators acquired data on return to baseline visual acuity in both groups.
“We did a survival analysis essentially for return to baseline, and that was statistically significantly different. We had to use an additional statistical technique to try to find out what the median return to baseline division was for the two groups,” he said.
Visual acuity and IOP
Baseline logMAR visual acuity was 0.3 in the Ex-Press group and 0.25 in the trabeculectomy group. Postoperative visual acuity was 0.28 in the Ex-Press group and 0.37 in the trabeculectomy group at 2 years.
Mean visual acuity decreased significantly in both groups at 1 day but recovered at 1 month in the Ex-Press group and 3 months in the trabeculectomy group.
Median return to baseline vision was 0.7 months in the Ex-Press group and 2.2 months in the trabeculectomy group.
Mean IOP decreased from 25.1 mm Hg at baseline to 14.7 mm Hg at 2 years in the Ex-Press group and from 26.4 mm Hg to 14.6 mm Hg in the trabeculectomy group. The decrease in IOP was statistically significant in both groups at all time points (P < .001).
“The average American patient goes to surgery after they have a lot of damage. In that situation, we tend to lean toward trabeculectomy if we need to achieve low pressures. This puts this [Ex-Press] procedure in the same category of efficacy, which is good to know because we can use this one much like we would with trabeculectomy to treat people who have advanced glaucoma damage,” Netland said.
Surgical success and complications
Average baseline number of medications was 3.1 in the Ex-Press group and trabeculectomy group. At 2 years, average medications were 0.9 in the Ex-Press group and 0.7 in the trabeculectomy group. The decrease in medications was statistically significant in both groups (P < .001).
The 2-year success rate was 83% in the Ex-Press group and 79% in the trabeculectomy group.
Complications were higher in the trabeculectomy group than in the Ex-Press group (P = .013). Five patients in the Ex-Press group and eight in the trabeculectomy group required subsequent glaucoma surgery.
“Patient recovery and patient acceptance of the procedure were good,” Netland said. “There are fewer steps involved, no iridectomy and no sclerostomy. The tissue is not really excised in this procedure. So, maybe a little bit less inflammation, maybe a better recovery.” – by Matt Hasson