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Clinical Comparison of a Monofocal eDOF IOL With a Monofocal IOL

NCT04631068 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-06-11

No results posted yet for this study

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

Conditions

  • Cataract

Interventions

PROCEDURE

Cataract surgery

Small incision cataract surgery with implantation of an intraocular lens

Sponsors & Collaborators

  • Advanced Vision Science, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Packer, MD · Medical Monitor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-21
Primary Completion
2023-03-17
Completion
2023-03-17

Countries

  • France
  • Portugal
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04631068 on ClinicalTrials.gov