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Risk assessment in phacoemulsification and implantation of extended-depth-of-focus IOL – a quality by design approach

Poster Details


First Author: D.Stanila ROMANIA

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

Abstract Details

Purpose:

The aim of this study is to evaluate the risks during and after implantation of EDOF Mini Well Intraocular Lens, a medical device well designed to benefit presbyopic patients with comfort and wellness of vision. The risk assessment is a Quality by Design (QbD) tool, a concept which is based on a well knowledge and understanding of the process and reflects in the quality of vision reflected in the quality of patient’s life.

Setting:

Ofta Total Clinic Sibiu Romania

Methods:

This study was done on 58 eyes/29 patients which were operated at Ofta Total Clinic from Sibiu, in the last 18 months. The patients were operated by the same surgeon, with the same facoemulsification machine, with the visual acuity(VA) before surgery between 0.1-0.9. After minimum 3 months after surgery we tested the visual acuity monocular and binocular with Snellen test, contrast sensitivity monocular and binocular with Pelli Robson test and photic phenomena with a subjective questionnaire.

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. All the tests after the surgeries were performed by the same team of the clinic. After the surgery the VA was 0,8-1,for far and near, the contrast sensitivity was 1,55-1,75  and the photic phenomena were not reported .

Conclusions:

For all the patient’s involved in this study photic phenomena were not reported. VA was 0,8-1, and  contrast sensitivity was 1,55-1,75 tested by Pelli Robson test. QbD can be a tool to evaluate the QofV in EDOF intraocular lens implantation

Financial Disclosure:

None

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