Lixin Wang1, Patricia Wolfe2, Sumit Paliwal2, Alexis Chernosky2, Thomas Kohnen3. 1. Global Ophthalmology Development, Novartis Pharmaceuticals Corporation, Fort Worth, Texas, USA. 2. Surgical Product Development, Alcon Vision, LLC, Fort Worth, Texas, USA. 3. Department of Ophthalmology, Goethe University Frankfurt, Frankfurt, Germany.
Abstract
PURPOSE: To determine whether total corneal incision enlargement after implantation of an intraocular lens with a new preloaded delivery system is comparable to a standard-of-care manual delivery system using an in vitro human cadaver eye model, despite having a smaller initial incision size. METHODS: Human cadaver phakic whole eye globes were used for these studies (n = 16 per group). Each pair of eyes was randomly assigned to a new preloaded delivery system (UltraSertTM) or a manual delivery system (MONARCH® III D). The surgical procedure included creating a 2.2- and 2.4-mm corneal incision for the preloaded and manual delivery systems, respectively, measuring intraocular pressure and pre-implantation corneal incision size, delivering the intraocular lens into the anterior chamber, and measuring the post-implantation incision size. RESULTS: The final corneal incision enlargement after intraocular lens delivery using the preloaded delivery system was 2.33 ± 0.04 mm, compared to 2.54 ± 0.05 mm after intraocular lens delivery with the manual delivery system. The mean corneal incision enlargement was comparable between the two systems, being 0.13 ± 0.04 mm using the preloaded delivery system and 0.14 ± 0.05 mm using the manual delivery system (p = 0.432). CONCLUSION: In a human cadaver eye model, the preloaded delivery system demonstrated an intraocular lens delivery performance on cornea incision enlargement was noninferior to the manual, standard-of-care intraocular lens delivery system despite a smaller initial incision size. TRANSLATIONAL RELEVANCE: Smaller incision sizes for cataract surgery improve patient outcomes via faster visual and wound recovery and decreased risk of complications such as postoperative inflammation and surgically induced astigmatism.
PURPOSE: To determine whether total corneal incision enlargement after implantation of an intraocular lens with a new preloaded delivery system is comparable to a standard-of-care manual delivery system using an in vitro human cadaver eye model, despite having a smaller initial incision size. METHODS: Human cadaver phakic whole eye globes were used for these studies (n = 16 per group). Each pair of eyes was randomly assigned to a new preloaded delivery system (UltraSertTM) or a manual delivery system (MONARCH® III D). The surgical procedure included creating a 2.2- and 2.4-mm corneal incision for the preloaded and manual delivery systems, respectively, measuring intraocular pressure and pre-implantation corneal incision size, delivering the intraocular lens into the anterior chamber, and measuring the post-implantation incision size. RESULTS: The final corneal incision enlargement after intraocular lens delivery using the preloaded delivery system was 2.33 ± 0.04 mm, compared to 2.54 ± 0.05 mm after intraocular lens delivery with the manual delivery system. The mean corneal incision enlargement was comparable between the two systems, being 0.13 ± 0.04 mm using the preloaded delivery system and 0.14 ± 0.05 mm using the manual delivery system (p = 0.432). CONCLUSION: In a human cadaver eye model, the preloaded delivery system demonstrated an intraocular lens delivery performance on cornea incision enlargement was noninferior to the manual, standard-of-care intraocular lens delivery system despite a smaller initial incision size. TRANSLATIONAL RELEVANCE: Smaller incision sizes for cataract surgery improve patient outcomes via faster visual and wound recovery and decreased risk of complications such as postoperative inflammation and surgically induced astigmatism.
Authors: Daniel Black; Dean Corbett; Timothy V Roberts; Brendan Cronin; Pamela J Smith; D Priya Janakiraman; Beth E Jackson Journal: Clin Ophthalmol Date: 2020-08-12