Brief Summary

The purpose of this study is to evaluate the clinical outcomes of an investigational IOL in patients undergoing cataract extraction and intraocular lens implantation using an improved injector system.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach

2 countries

5 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.5 years study duration

Study Start

First participant enrolled

March 13, 2015

Completed

27 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2015

Completed

7 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2016

Completed

2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2018

Completed

Last Updated

May 21, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

April 9, 2015

Last Update Submit

May 20, 2021

Conditions

Aphakia

Keywords

Cataract

Outcome Measures

Primary Outcomes (3)

Accommodative amplitude
Accommodative amplitude is a measure of the ability of the eye to focus from a target that is at distance into a target that is near.
Month 6
Best corrected distance visual acuity (BCDVA)
Visual acuity of the eye will be tested with the correction in place.
Month 6
Rates of adverse events
Adverse events will be collected from time of enrollment to study exit.
Up to Month 36

Study Arms (1)

FluidVision

EXPERIMENTAL

FluidVision AIOL implanted in the capsular bag of the eye during cataract surgery

Device: FluidVision AIOLProcedure: Cataract surgery

Interventions

FluidVision AIOLDEVICE

Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject. An improved injector system was used.

FluidVision

Cataract surgeryPROCEDURE

Performed using standard microsurgical techniques

FluidVision

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Eligible for primary intraocular lens implantation for the correction of aphakia following cataract extraction;
Best corrected distance visual acuity worse than 20/40 either with or without a glare source present (e.g. Brightness Acuity Tester);
Less than or equal to 1.0 diopter (D) of preoperative keratometric astigmatism;
Willing and able to comply with schedule for follow-up visits for 36 months after surgery.

You may not qualify if:

Systemic disease that could increase the operative risk or confound the outcome (e.g. autoimmune disease, diabetes);
Taking systemic medications that may confound the outcome or increase the risk to the subject;
Ocular conditions that may predispose for future complications;
Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject;
Pregnant, lactating during the course of the investigation, or with another condition associated with fluctuation of hormones that could lead to refractive changes;
Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future best corrected visual acuity loss worse than 20/40.

Contact the study team to confirm eligibility.