Primary baerveldt versus trabeculectomy study after 5 years of follow‐up

Abstract

Purpose: Although the Baerveldt glaucoma implant (BGI) initially was reserved for refractory glaucoma, its role in the surgical management of glaucoma has shifted towards a primary treatment choice. We performed a randomized prospective study to compare BGI surgery and trabeculectomy (TE) in patients without previous ocular surgery. Methods: We included 119 glaucoma patients without previous ocular surgery. One eye of each subject was randomized to either a BGI or TE. Follow-up visits were at 1 day, 2 weeks, 6 weeks, 3 months, 6 months and 1, 2, 3, 4 and 5 years postoperatively. Primary outcomes were intraocular pressure (IOP) and failure rate. Secondary outcomes were medication, anterior chamber laser flare value and complications. Results: After 5 years, an IOP of 12.7 AE 3.9 mmHg (mean AE SD) was achieved in the TE group and 12.9 AE 3.9 mmHg in the BGI group. We found no statistically significant difference in failure rate between the groups (p = 0.72). More BGI patients needed additional medication to control their IOP (85%; 1.9 AE 1.2 types of glaucoma medication) compared to the TE patients (57%; 0.5 AE 0.9 types of glaucoma medication). Diplopia was significantly more present in the BGI group than in the TE group (27% versus 4%; p < 0.001). The self-limiting complication rate was similar in both groups. Conclusions: Our study demonstrates that, in the long term, the final IOP and failure rate are similar after TE and BGI surgery. However, the need for additional medication after BGI surgery is higher than after TE. Also, the increased risk of developing diplopia after BGI surgery must be taken into consideration.

The long‐term postoperative effect of the Baerveldt glaucoma drainage device and of a trabeculectomy on the corneal endothelium

“…As a result, the postoperative ECD is a good indicator of the difference in effects that TE and BGI surgery have on the corneal endothelium. During the current study, postoperative complication rates, visual function, intraocular pressure and the number of glaucoma medications were not obtained, contrary to the original RCT in which our current study population participated (Islamaj et al 2018(Islamaj et al , 2019. However, these factors may affect the loss of endothelial cells and should be included in new studies on this topic.…”

“…In addition, a statistically significantly higher flare count was measured in the BGI group than in the TE group, possibly due to the presence of a foreign body in the eye (Islamaj et al. 2019). No correlation was found between the ECD and flare count, which is in line with previous research (Hau et al.…”

“…More than 10 years ago, we started a prospective, randomized clinical trial with a follow-up period of 5 years, in which we compared TE and BGI surgery, performed at the Rotterdam Eye Hospital, the Netherlands (Islamaj et al 2018(Islamaj et al , 2019. Unfortunately, no ECD measurements were performed at baseline.…”

“…The original study enrolled 119 patients of whom 105 remained for analysis after five years of follow‐up (Islamaj et al. 2019). After being invited, a total of 70 patients were willing to participate in the current study.…”

“…All patients underwent TE or BGI surgery between 2007 and 2014 and were invited for an examination of their endothelium between February and October 2019. The original study enrolled 119 patients of whom 105 remained for analysis after five years of follow-up (Islamaj et al 2019). After being invited, a total of 70 patients were willing to participate in the current study.…”