A New Small-Aperture Device Implanted on Top of the Intraocular Lens: Safety, Feasibility, and First Clinical Results.

PURPOSE To investigate the feasibility and safety of a new small-aperture device, which is implanted on top of the intraocular lens. METHODS Regular cataract surgery was performed in both eyes in 7 patients. In the non-dominant eye, a small-aperture device (VisionXtender; Morcher) was additionally implanted into the capsular bag at the end of the surgery. The mask had an inner diameter of 1.4 mm. Feasibility and safety were investigated 3 months and 2 years after surgery. RESULTS In all cases, the device was successfully positioned in the capsular bag without any intraoperative complications. No inflammation was observed at the 3-month follow-up visit. All patients achieved binocular uncorrected distance visual acuity of 0 logarithm of the minimum angle of resolution (log-MAR) or better. Additionally, distance-corrected intermediate visual acuity of 0.1 logMAR or better was measured in the non-dominant eye. Two years postoperatively, Nd:YAG capsulotomy was performed in three patients in both eyes. CONCLUSIONS This clinical feasibility trial demonstrates that the use of the new small-aperture device is both easy and safe. No intraoperative or postoperative complications were reported. All patients attained satisfactory distance, intermediate, and near visual acuity. The device shows significant potential when used in combination with different intraocular lenses (eg, toric). In the future, different opening shapes seem to be possible. [J Refract Surg. 2024;40(9):e662-e666.].