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SCIENTIFIC
PROTOCOL

Scientific Protocol

The REALVISION 3D MEDICAL MONITOR is certified for medical use and is the only
one that can boast a specific clinical trial presented at the worldwide congress of
Urology in San Diego (US) which has demonstrated the validity and the advantages of
the Realvision 3D compared to the classic 3D with glasses.

Introduction

3D technology has been extensively used in the last years during laparoscopic and robotic surgery.
The polarized lenses required to obtain adequate images during
the procedures can induce visual fatigue and headache.
The aim of the study was to document and characterize possible abnormalities
in visual perception during after 3 D compared to 2 D laparoscopy..

Material and Methods

The results indicate that 3D system induces an overall damage of visual function evident at the optometric evaluation.
The members of three different surgical teams, each including two surgeons and one scrub nurse, were individually studied in the last six months.
Each team member has been tested before and after 2 D and 3 D laparoscopic procedures (3+3, respectively for each team) lasting from about 150 to 240 min.
The employed techniques (radical and partial nephrectomy, radical prostatectomy, dismembered pyeloplasty and living donor nephrectomy) were homogeneously distributed among the  2 groups.
Before and after every surgery, the components underwent a standard optical test including visual field evaluation, visual evoked potentials and optometric tests.
The last included Gabor, Random Dot, stereo circles, fixation disparity, optotype stereo and phoria-T.
The results obtained for each component were recorded for the 2 visual systems and statistically analyzed using Wicoxon signed rank and Mc Nemar tests as appropriate.

Results

No differences between pre and post standard visual tests were evident for any of the surgical teams’ components referred to both 2 D and 3 D systems. The same results were obtained for the neuro-sensitive tests. At the optometric evaluation a significant alteration of pre vs post random dot test was found only in the contest of 3 D procedures (32.5+/- 4.6 vs 45.0+/-7.5; p<0.05). After qualitative analysis a significant alteration was documented after 3D vs 2 D procedures for fixation disparity (75% vs 37.5%; p<0.05) and phoria-T test (37,5% vs 12.5%; p<0.05).

Discussion

Our results indicate that 3 D system induces an overall damage of visual function evident at the optometric evaluation. This damage does not involve ocular function or optical nerve but rather the stream nerve fibres that travel from the occipital cortex to the posterior parietal area (magno system) and to temporal lobe (parvo system). These fibers are responsible of stereoptic function which represents the cognitive elaboration of visual signal by brain cortex. Particularly when dealing with long lasting 3 D procedures surgeon and patient should be made aware of these data.