PILOT INVESTIGATION INTO DEVICE DEFICIENCIES AND CORNEAL MORPHOLOGY WITH FOUR IOL DELIVERY SYSTEMS.

A pilot study to evaluate the performance of an automated preloaded intraocular lens (IOL) system (AutonoMe (A)), two non-automated preloaded (iTec (iT) and iSert (iS)) and a manual delivery system (Monarch III (MIII)) in terms of injector deficiencies, corneal morphology and clinical outcomes, at 2.5 hours and 1 month post cataract surgery.

University Hospitals Sussex NHS Foundation Trust, Brighton, United Kingdom & Univesity Clinic Frank Furt, Germany.

Prospective, multicenter, randomized, observer-masked pilot study of 24 subjects (N=48 eyes, 12/group). The 4 injectors were evaluated for deficiencies such as haptic trailing, nozzle tip splitting, IOL damage and sudden IOL injection. Anterior segment ocular coherence tomography (AS-OCT) was performed to evaluate corneal incision size, epithelial and endothelial gaping and misalignment, central corneal thickness (CTT), and corneal thickness at the incision site (CTIS). Specular microscopy was performed to assess endothelial cell counts (ECC). Clinical outcomes of best-corrected distance visual acuity (BCDVA) and surgically induced astigmatism (SIA) were also captured.

Injectors A and MIII displayed 0 device deficiencies. iT and iS had 11 and 9 deficiencies respectively, the most common of which were nozzle tip splitting and sudden IOL ejection. At 2.5 hours, incision gaping was highest in iS (50.0%) due to epithelial gaping (iT: 16.7%, MIII: 8.3% and A: 8.3%). No epithelial misalignment was found in A or MIII versus 3 eyes with iS and iT each. At 1 month all but 1 eye (iT) were fully healed. CTT and CTIS were similar among injectors, and numerically greater in the A group. At 1 month, mean BCDVA ranged from -0.008 logMAR with Clareon IOLs (A) to 0.055 Tecnis ZCB00 (iT). ECC was similar between the systems. SIA magnitude was lowest with A and MIII.

This pilot study found that A and MIII have lower device deficiencies than iT and iS. Initial epithelial gaping and misalignment settles at 1 month. The AS-OCT is not the best tool to evaluate incision size and location at 2.5 hours post-operatively.