Clinical Comparison of a Monofocal eDOF IOL With a Monofocal IOL

Status Completed

Clinical Trial Summary

Post-market, prospective, randomized, single-masked, multi-center clinical study investigating the safety and effectiveness of the Monofocal Extended Depth of Focus Intraocular Lens (Mono-EDoF IOL) when compared to a Standard Monofocal Intraocular Lens. Primary Objectives: - To evaluate the distance VA of the study IOLs - To evaluate the intermediate VA of the study IOLs - To explore the safety profile with regards to visual disturbances

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Cataract

Clinical Trial Details

NCT number	NCT04631068
Study type	Interventional
Source	Advanced Vision Science, Inc.
Contact
Status	Completed
Phase	N/A
Start date	September 21, 2020
Completion date	March 17, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04685538` - Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.	Phase 3
Recruiting	`NCT06060041` - IC-8 Apthera IOL New Enrollment Post Approval Study
Recruiting	`NCT05518539` - Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens
Recruiting	`NCT05271942` - Tilt and Tumble vs Divide and Conquer - a Unique Comparison of the Two Cataract Surgery Methods	N/A
Active, not recruiting	`NCT04778501` - PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Asia	N/A
Completed	`NCT05062564` - Efficacy of LipiFlow in Patients Affected by Meibomian Gland Dysfunction in Reducing Post-cataract Surgery Dry Eye	N/A
Completed	`NCT03751033` - Influence of DisCoVisc Ophthalmic Viscosurgical Device (OVD) on Intraoperative Aberrometry Readings	N/A
Completed	`NCT02529488` - Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00	N/A
Completed	`NCT04539548` - A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract	Phase 3
Completed	`NCT03740659` - Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery	Phase 2
Completed	`NCT03494257` - Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification	N/A
Completed	`NCT05119127` - Rotational Stability of Acrysof IQ Vivity Extended Vision Toric IOL and Refractive Visual Outcome.	N/A
Active, not recruiting	`NCT04271709` - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)	N/A
Recruiting	`NCT03713268` - Intraoperative OCT Guidance of Intraocular Surgery II
Completed	`NCT03739528` - Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery	Phase 3
Completed	`NCT02888210` - A Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery	Phase 3
Completed	`NCT03356847` - Evaluation of the Rotational Stability of the Monofocal SISA Implant Following Cataract Surgery	N/A
Completed	`NCT04332640` - Clinical Evaluation of the Next Generation Phaco System	N/A
Recruiting	`NCT03638726` - Subconjunctival Atropine and Intracameral Epinephrine for Pupil Dilation in Phacoemulsification	Phase 4
Completed	`NCT03050697` - Evaluation of the Safety and Performance of the HARMONI® Toric Lens	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Comparison of a Monofocal eDOF IOL With a Monofocal IOL — MonoeDOF

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms