Clinical Evaluation of a Novel Preloaded Intraocular Lens Delivery System During Routine Cataract Surgery.

PURPOSE

To evaluate the clinical handleability and acceptability of a novel preloaded intraocular lens (IOL) delivery system for implantation of the TECNIS ZCB00 IOL (Johnson & Johnson Surgical Vision, Inc., Santa Ana, CA, USA) during routine small-incision cataract surgery.

SUBJECTS AND METHODS

In this prospective, open-label, noncomparative, unilateral or bilateral, multicenter study, adult subjects with unilateral or bilateral cataracts scheduled for IOL implantation were enrolled. Surgeons and surgical technicians completed per-eye day-of-surgery and end-of-surgical-day questionnaires. The primary endpoint of the study was the rate of acceptable overall clinical performance of the preloaded IOL delivery system. Other endpoints included additional responses from the questionnaires, preimplantation incision size, and safety.

RESULTS

The study included 91 eyes that underwent cataract surgery and IOL implantation using the preloaded delivery system and were available for the 1-day postoperative visit. Five surgeons and 14 surgical technicians from four investigational sites participated in the study. The rate of acceptable overall clinical performance was 100% (91/91) of eyes, with most responses (78/91; 85.7%) being the highest possible rating of 5 (very satisfied). Favorable responses by most surgeons and surgical technicians regarding additional endpoints further highlighted the handleability and acceptability of the preloaded delivery system. No ocular adverse events or lens findings (ie, no cases of IOL instability, haptic breakage, IOL marking, or crimping) were reported.

CONCLUSION

The results of this study demonstrated that this preloaded IOL delivery system was safe and effective during routine small-incision cataract surgery.

TRIAL REGISTRATION

German Clinical Trials Register identifier, DRKS00014757.