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Safety assessment of a new single-use small-incision injector for intraocular lens implantation
Alexandra Satanovsky1, Shmuel Ben-Eliahu, David J Apple
1Medical School of the Hebrew University and Hadassah, Jerusalem, Israel.
Purpose:
To evaluate the safety of a new injector, the Raysert R-INJ-04/18, for implantation of the C-flex intraocular lens (IOL).
Setting:
Ophthalmology Department, Kaplan Medical Center, Rehovot, Israel.
Design:
Experimental study.
Methods:
Sixty IOLs were subdivided into 2 equally sized groups. Group A IOLs were injected using the established R-INJ-04 injector, and those in Group B were injected with the new injector. The IOLs were injected into a Petri dish. Subsequently, all IOLs and injectors were evaluated macroscopically and microscopically and then photographed under light microscopy (LM). Two IOLs in each group were randomly chosen and sent for evaluation by scanning electron microscopy (SEM) and energy dispersive analysis of x-ray. All remaining IOLs were sent for power and modulation transfer function (MTF) analysis.
Results:
All Group B IOLs were successfully injected without evident signs of scratching, cracks, or deposits on LM and SEM examination. In Group A, findings were confined to a singular incidence of a small deposit detected on the periphery of the posterior optical surface of the IOL, with corresponding findings detected on the injector nozzle. No signs of scratching, cracks, or deposits were found in the rest of the IOLs or injectors. The power and MTF analyses were within the normal range for all IOLs.
Conclusion:
The new 1.8 mm external diameter soft-tipped injector for 2.4 to 2.2 mm incisions was shown to be safe for the implantation of the C-flex 21.0 diopter IOL.
