Clinical Evaluation of the FluidVision Accommodating 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

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-14

Study Completion Date

2017-11-06

Brief Summary

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The purpose of this study is to evaluate the safety and effectiveness of an investigational IOL.

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Detailed Description

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Eligible subjects will receive the investigational IOL in one eye and be followed at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months and 36 months post-operation.

Conditions

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Aphakia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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FluidVision

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

Performed using standard microsurgical techniques

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

Cataract Surgery

Performed using standard microsurgical techniques

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No