Posters

Evaluation of quality of vision in EDOF intraocular lens implantation with Ishikawa diagram

Poster Details

First Author: A.Stanila ROMANIA

Co Author(s):    D. Stanila   A. Panga                 

Abstract Details

Purpose:

The aim of this study is to evaluate the risks of Ishikawa diagram regarding the implantation of EDOF Mini Well Intraocular Lens, a medical device well designed for presbyopic patients so that they can benefit from comfort and wellness of vision. Ishikawa diagram, fishbone diagram, also called a cause and effect diagram, is a visualization tool for categorizing the potential causes of a problem in order to identify its root causes.

Setting:

Ofta Total Clinc Sibiu Romania University Lucian Blaga Faculty of Medicine Sibiu Romania

Methods:

This study was performed on 64 eyes/32 patients who were operated at Ofta Total Clinic from Sibiu, in the last 2 years. The patients were operated by the same surgeon with same team, with Centurion machine, and FLACS, by lenSx machine. The visual acuity (VA) before surgery was between 0.1-0.9. After minimum 6 months after surgery we tested visual acuity with Snellen test,contrast sensitivity with Pelli Robson test and dysphotopsic phenomena with a subjective questionnaire. In Ishikawa diagram we analysed the instruments used preoperatively, FLACS, implantation of Mini Well Ready lens, instruments used postoperatively, results after implantation and patients’ satisfaction.

Results:

The risks during implantation were minimized because all the surgeries were performed in the same conditions, by the same surgeon and with the same machines and by the same team of the clinic. After the surgery, the VA was 0,8-1, for far and near vision, the contrast sensitivity was 1,55-1,75 and the photic phenomena were not reported. Comments of identified risk factors: the calculation of the power of the lens, the surgeon experience, the surgery team, subjective questionnaire and IQ of patients. We analysed failure mode effects for risk assessment, like potential failure mode, potential failure effect, potential cause of failure and control methods. We elaborate a score regarding occurrence (O), severity (S), detectability (D) noted with 1- 5 points each of them and we calculated the RPN (Risk Priority Number) by multiplying 1x2x3.(OxSxD) We find the highest score for surgical team 24, followed by surgeon experience 10, IQ of patients and biometry.

Conclusions:

VA was 0,8-1, and contrast sensitivity was 1,55-1,75 tested by Pelli Robson test. For all the patient’s involved in this study, photic phenomena were not reported. QbD can be a tool to evaluate the QofV in EDOF intraocular lens implantation. Ishikawa diagram can help us through RPN to evaluated the risks in implantation of EDOF IOL. Surgery team is with the highest score,24, because the human factor is unforeseeable.

Financial Disclosure:

None