Clinical Evaluation of the FluidVision Accommodation Intraocular Lens (AIOL)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-27

Study Completion Date

2019-12-06

Brief Summary

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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.

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Detailed Description

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Upon obtaining written informed consent and confirmation of subject eligibility via preoperative assessments, subjects were randomized in a 1:1 ratio to receive either the investigational IOL or the commercially available trifocal IOL in both eyes. The second eye for each subject was implanted after completion of the 1-week follow up for the first implanted eye. The expected total duration of participation for each subject was up to 14 months.

Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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FluidVision

FluidVision AIOL implanted in the capsular bag of the eye during cataract surgery. Both eyes were implanted, with the second eye surgery occurring after the Week 1 follow up for the first eye surgery.

Group Type EXPERIMENTAL

FluidVision AIOL

Intervention Type DEVICE

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

Cataract surgery

Intervention Type PROCEDURE

Cataract surgery per investigator's standard practice

PanOptix

Commercially available trifocal IOL implanted in the capsular bag of the eye during cataract surgery. Both eyes were implanted, with the second eye surgery occurring after the Week 1 follow up for the first eye surgery.

Group Type ACTIVE_COMPARATOR

AcrySof IQ PanOptix Trifocal IOL

Intervention Type DEVICE

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

Cataract surgery

Intervention Type PROCEDURE

Cataract surgery per investigator's standard practice

Interventions

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FluidVision AIOL

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

Intervention Type DEVICE

AcrySof IQ PanOptix Trifocal IOL

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

Intervention Type DEVICE

Cataract surgery

Cataract surgery per investigator's standard practice

Intervention Type PROCEDURE

Other Intervention Names

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PanOptix

Eligibility Criteria

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Inclusion Criteria

* Require cataract extraction by phacoemulsification;
* Corrected Distance Visual Acuity (CDVA) worse than 20/40 Snellen, or presence of visually significant lens opacity;
* Preoperative or predicted postoperative astigmatism of ≤ 1.0 diopter.

Exclusion Criteria

* Use of current medications that may affect accommodation or confound study results;
* Systemic disease that may increase the operative risk or confound results;
* Ocular conditions or degenerative disorders that may predispose the subject to future complications;
* Monocular subjects or significant permanent visual function loss in 1 eye;
* Previous ocular surgery in either eye that may confound the results or increase the risk to the subject.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No