Primary Baerveldt versus trabeculectomy study after one-year follow-up.

PURPOSE: To compare a Baerveldt implant and trabeculectomy with respect to intraocular pressure (IOP) and failure rate at 1 year of follow-up. Secondary outcomes are pharmacological therapy and complications at 1 year of follow-up.

METHODS

This was a randomized, comparative study. A total of 119 glaucoma patients without previous ocular surgery were included at the Rotterdam Eye Hospital, the Netherlands. One eye of each subject was randomized to either a Baerveldt glaucoma drainage device (BGI) or trabeculectomy (TE). Follow-up visits were conducted at 1 day, 2 weeks, 6 weeks, 3 months, 6 months and 1 year after surgery.

RESULTS

After one year, the final IOP was equivalent for both treatment groups: 14 ± 4 mmHg (mean ± SD) for the Baerveldt group versus 13 ± 4 mmHg for the trabeculectomy group. Statistically, we found no significant difference in failure rate between the two groups. However, the Baerveldt group needed significantly more medication to decrease IOP. Overall, self-limiting complication rate was similar in both groups. Diplopia, a serious complication, was significantly more present in the BGI group.

CONCLUSION

One year after surgery, TE shows better results than the BGI. The final IOP, IOP reduction and failure rate are similar, but the need for additional IOP lowering medication in the BGI group is higher as well as the complication rate. The increased risk of developing diplopia after placement of a BGI must be taken into consideration.