Clinical Evaluation of the FluidVision Accommodation Intraocular Lens (AIOL)

PowerVision95 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

DOUBLE

Enrollment

Conditions

Cataract

Interventions

FluidVision AIOLDEVICE

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

AcrySof IQ PanOptix Trifocal IOLDEVICE

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

Cataract surgeryPROCEDURE

Cataract surgery per investigator's standard practice

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Key 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. Key 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.

Locations (1)

PowerVision Investigative Site

Somerset West, South Africa

Outcomes

Primary Outcomes

Distance Corrected Near Visual Acuity (DCNVA) at 100% Contrast - First Implanted Eye

Visual acuity was tested at a distance of 40 centimeters with distance correction (plus or minus power) in place.

Time frame: Month 6 postoperative

Secondary Outcomes

Distance Corrected Intermediate Visual Acuity (DCIVA) at 100% Contrast - First Implanted Eye

Visual acuity was tested at a distance of 66 centimeters with distance correction (plus or minus power) in place.

Time frame: Month 6 postoperative

Distance Corrected Near Visual Acuity (DCNVA) at low contrast - First Implanted Eye

Visual acuity was tested at a distance of 40 centimeters with distance correction (plus or minus power) in place.

Time frame: Month 6 postoperative

Percentage of Eyes with 20/32 or Better Visual Acuity Between 4 meters and 40 centimeters on the Defocus Curve

A series of plus and minus lenses were placed over the subject's best distance manifest correction to simulate distances from far to hear.

Time frame: Month 6 postoperative

Data from ClinicalTrials.gov

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