Clinical Comparison of a Monofocal eDOF IOL With a Monofocal IOL

Summary

Participation Requirements

Description

This study is aimed at patients who have a cloudy lens in both of their eyes, and are eligible for cataract surgery with implantation of an intraocular lens. Patients should be otherwise healthy with no other eye diseases. The study will take place in 3 centers in Europe, including Oxford Eye Hospit...

This study is aimed at patients who have a cloudy lens in both of their eyes, and are eligible for cataract surgery with implantation of an intraocular lens. Patients should be otherwise healthy with no other eye diseases. The study will take place in 3 centers in Europe, including Oxford Eye Hospital, a part of Oxford University Hospitals NHS Trust and will include 70 patients in total. The aim of the study is to investigate the safety and effectiveness of a new Intraocular Lens (IOL): the Monofocal Extended Depth of Focus (Mono-EDoF ME4) IOL and to compare it to a standard Monofocal IOL (TECNIS ZBC00). Patients participating will be randomised to either receive the Mono-EDoF ME4 IOL in both eyes or the TECNIS ZCB00 IOL in both eyes. Twice as many subjects will receive the Mono-EDoF ME4 IOL compared to the TECNIS ZCB00 IOL. Both IOLs have received the CE marked. The aim with both IOLs is to provide patients good vision at distance with no glasses. The Mono-eDoF ME4 might offer the additional benefit of achieving good vision at intermediate distance without glasses. Total duration of clinical investigation is 12 months and the total expected duration for each patient is 8 months. Patients will be screened for eligibility preoperatively obtaining a medical history and to establish a baseline ocular condition. Surgeries will be performed on different dates for both eyes but not more than one month apart. The patient will need to return to for seven follow-up visits after eye surgery where vision and health of the eye will be assessed.

Tracking Information