Visual Outcomes With Virtual Implantation Of Iol´S

To evaluate a technique of simulated IOL implantation that allows subjects to view through IOLs.

JENVIS Research c/o Ernst Abbe University Jena, Germany

In this masked clinical trial, the visual performance of a monofocal and two marketed full vision range (FVR) IOLs were compared using a device for simulated implantation called VirtIOL^®. The IOL is optically imaged at the iris plane by the VirtIOL device. 64 test persons aged 19 to 41 years were evaluated for all models. Photopic monocular distance corrected defocus curves were measured using the Freiburg Vision and Contrast Test at a four-meter distance under cycloplegic conditions. Additionally, subjects sized the halo burst pattern and rated the severity of halos visually produced by an LED pinlight source at 4m in mesopic conditions. The VirtIOL aperture was set to 3.5 mm under photopic conditions and 4.5 mm for mesopic conditions.

The monofocal IOL provided higher mean monocular visual acuity at 0.0 D defocus compared to FVR1 and  FVR2, but  lower visual acuity from -1.25 D to -3.5 D. The cumulative effective pseudo-accommodation calculated by adding segments of the curve at or above the logMAR level of +0.2 was -1.15 D for the monofocal IOL, -3.44 D for FVR1, and -2.83 D for FVR2. The monofocal IOL had the smallest mean burst pattern size (3.51 ± 0.76 deg), followed by FVR1 (4.61 ± 1.33 deg) and FVR2 (5.31 ± 0.60 deg). Subjectively, the same trend was observed with 22%, 35% and 63% of subjects reporting a “severe” halo for monofocal, FVR1 and FVR2 respectively.

Expected relative defocus curves and visual disturbances for the monofocal IOL and the FVR IOLs confirm the usability of the VirtIOL device.  Nevertheless, the monocular study design, the younger subject group and the possibility of minor off axis view are limiting a direct comparison with clinical real world data.