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VisiOn Restoration With FluidVisION Accommodating Intraocular Lens (AIOL)

NCT03925545 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2021-05-21

No results posted yet for this study

Summary

The objective of this study is to obtain an initial assessment of the safety and performance of an investigational AIOL in patients 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 monofocal IOL

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

PROCEDURE

Cataract surgery

Standard cataract extraction with phacoemulsification

Sponsors & Collaborators

  • PowerVision

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-17
Primary Completion
2018-11-27
Completion
2018-11-27
FDA Device
Yes

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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 NCT03925545 on ClinicalTrials.gov