Advanced Preloaded IOL System A Visco-free Preloaded Injector Kimiya Shimizu MD Professor & Chairman, Department of Ophthalmology Kitasato University,

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Presentation transcript:

Advanced Preloaded IOL System A Visco-free Preloaded Injector Kimiya Shimizu MD Professor & Chairman, Department of Ophthalmology Kitasato University, School of Medicine Kanagawa, Japan ASCRS in Chicago 2008

To report the development of a new preloaded IOL injector: Visco-free Preloaded Injector, which requires no Ophthalmic Viscosurgical Device (OVD) either for loading an IOL or for forming and maintaining an anterior chamber and a capsular bag. Purpose Connect to irrigation tube BSS BSS flow IOL preloaded Specification of Visco-free Injector

Basic Experiment Performances of Visco-free Injector 1. IOL Ejection Time 2. Maximum Resistance Force during IOL Ejection Space Formation in a Porcine Eye 3. IOP Measurement during Irrigation 4. Slit Lamp Examination Clinical Experiment 11 eyes of 11 patients (including a glaucoma eye)

1. IOL Ejection Time  Injector plunger was advanced automatically at 1.3 mm/sec  Ejection time was estimated from sequence of photographs (15 frames/sec) 2. Maximum Resistance Force  Advanced the plunger automatically at 0.25mm/sec  Measured a resistance force by the material tester (MT-RQ®) Basic Experiment IOL ejection process Methods

Basic Experiment 3. IOP Measurement during Irrigation  After PEA, bottle height: 50cm (I/A tube)  IOP measurement (Shiötz tonometer)  Compared with the Healon ® (0.3mL) 4. Slit Lamp Examination  After PEA, filled a porcine eye with BSS or OVD (tinted by NaFlu)  Observed by a slit lamp Methods

Clinical Experiment  11 eyes of 11 patients / 67.8±10.0 yo.  3.2mm clear corneal incision  Measurements IOP ： Pre, Post 1D Corneal endothelium cell density: Pre, Post 6M Methods

Clinical Experiment 1. Connect to irrigation tube. 2. Irrigate with BSS using foot pedal. 4. Create space in capsular bag by BSS irrigation only. 3. Insert tip into incision while irrigating with BSS.

Basic Experiment: Performance of Visco-free Injector Visco-free3.0±0.4 sec169.1±39.8 g With Healon ® 2.2±0.6 sec173.8±24.9 g (n=10) Max resistance IOL ejection Displacement (mm) Resistance force (g) Ejection time Resistance force Results N.S.

Basic Experiment: Space Formation With BSS, higher IOP and larger space formation. Results * p< mmHg

Clinical Experiment An IOL was implanted in the bag in all cases. No significant IOP rising in all cases. Corneal endothelium cell did not decrease. Pre-op (n=11)Post 6M (n=7) 2753± ±215 (-7%) Results (cells/mm 2 ) N.S.

Advantages of Visco-free Injector Requires no OVD for  Loading an IOL  Space formation in anterior chamber & capsular bag  Not necessary to wash out OVD after implantation  Reduction of postoperative high IOP risk due to residual OVD Simpler & Safer for Surgery Conclusion

Visco-free Preloaded Disposable Injector Preloaded Speedy & Safe  Preloaded Speedy & Safe No OVD Shortens surgical procedure  No OVD Shortens surgical procedure & reduces risk of post-op high IOP & reduces risk of post-op high IOP Conclusion