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Clinical Evaluation of the FluidVision Accommodation Intraocular Lens (AIOL)

NCT03508778 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2021-05-24

No results posted yet for this study

Summary

The objective of this study is to evaluate the safety and effectiveness of an investigational IOL in providing a range of vision as compared to a commercially available trifocal IOL in subjects undergoing cataract extraction and IOL implantation.

Conditions

  • Cataract

Interventions

DEVICE

FluidVision AIOL

Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject

DEVICE

AcrySof IQ PanOptix Trifocal IOL

Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject

PROCEDURE

Cataract surgery

Cataract surgery per investigator's standard practice

Sponsors & Collaborators

  • PowerVision

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-27
Primary Completion
2019-06-11
Completion
2019-12-06
FDA Device
Yes

Countries

  • South Africa

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 NCT03508778 on ClinicalTrials.gov