Objective: To evaluate the safety and the efficacy of a novel miniature glaucoma implant the Ex-PRESS in reducing the intra-ocular pressure in eyes operated for open-angle glaucoma combined with phaco-emulsification.
Methods: A prospective multi-center study included twenty-nine eyes of Caucasian patients. Phacoemulsification was performed first, and after the IOL was in the capsular bag, the Ex-Press was implanted at the limbus.
Results:. The Ex-PRESS implantation duration was less than 5 minutes. All patients included were implanted successfully. The mean follow up was 22 weeks (2 to 12 months). Mean IOP was reduced from 23.6 plus-minus 1.1mmHg pre-operatively to 15.4 plus-minus 1mmHg at 26 weeks. Mean IOP reduction in percentage was 35.5 plus-minus 3.8, and was statistically significantly lower than 30% at 6 month. The need for antiglaucoma medication was dramatically reduced (only one patient still on medication at the last visit). There were no cases of inflammation, infection, extrusion or irreversible damage to the eye. Complications encountered included 1 case of conjunctival erosion, resolved by one conjunctival suture, and 2 cases of transient flat anterior chamber with choroidal detachment. One of the latter was a failure and needed re-operation for further IOP reduction.
Conclusions: The Ex-PRESS implantation is a simple and time sparing surgery. We believe that the 6 months results indicate that the Ex-PRESS can be considered as a safe alternative to trabeculectomy in combined surgery.