Clinical Evaluation of the FluidVision Accommodating Intraocular Lens (AIOL)

Not Applicable

Completed

• Conditions: Aphakia
• Interventions: Device: FluidVision AIOL; Procedure: Cataract Surgery

• Registration Number: NCT02049567
• Lead Sponsor: PowerVision

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2014-01-14
• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2014-01-28
• Study First Posted: 2014-01-30
• Primary Completion: 2015-06-24
• Study Completion: 2017-11-06
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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.
• Other protocol-defined inclusion criteria may apply.

Key

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.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FluidVision	Cataract Surgery	FluidVision AIOL implanted in the capsular bag of the eye during cataract surgery
FluidVision	FluidVision AIOL	FluidVision AIOL implanted in the capsular bag of the eye during cataract surgery

Primary Outcome Measures

Name	Time	Method
Best corrected distance visual acuity (BCDVA)	Month 6	Visual acuity of the eye will be tested with the correction in place.
Accommodative amplitude	Month 6	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.
Rates of adverse events	Up to Month 36	Adverse events will be collected from time of enrollment to study exit

Trial Locations

Locations (1)

PowerVision Investigative Site; 🇿🇦 Paardevlei, Somerset West, South Africa