VisiOn Restoration With FluidVisION Accommodating Intraocular Lens (AIOL)

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: FluidVision AIOL; Procedure: Cataract surgery; Device: AcrySof IQ monofocal IOL

• Registration Number: NCT03925545
• Lead Sponsor: PowerVision

Brief Summary

The objective of this study is to obtain an initial assessment of the safety and performance of an investigational AIOL in patients undergoing cataract extraction and IOL implantation.

Detailed Description

This study was originally designed as a single arm, unilateral study (one eye, one product only) to obtain an initial assessment of the safety and performance of an investigational IOL in subjects undergoing cataract extraction and IOL implantation. The study design was later modified to a contralateral study (both eyes, different product in each eye) to compare the safety and performance of the investigational IOL to a commercially available monofocal IOL.

Study Timeline

• Study Start: 2017-01-17
• Primary Completion: 2018-11-27
• Study Completion: 2018-11-27
• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-24
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Corrected distance visual acuity (CDVA) worse than 20/40, or presence of visually significant lens opacity;
• Preoperative or predicted postoperative astigmatism of ≤ 1.0 diopter (D);
• Calculated IOL power within range.

Key

Exclusion Criteria

• Current medication that may affect accommodation;
• Systemic disease or concomitant medication that may increase operative risk or confound results;
• Ocular conditions that may predispose the subject for future complications;
• Monocular subjects or subjects with significant permanent visual function loss in fellow eye;
• Previous intraocular or corneal surgery in either eye that may confound the results or increase the risk to the subject, including implantation of a multifocal IOL or other presbyopic corrective surgery in the fellow eye;
• Grade 4 cataract of any type.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Unilateral	FluidVision AIOL	Implantation with the FluidVision AIOL in one eye during cataract surgery. Only one eye was treated.
Unilateral	Cataract surgery	Implantation with the FluidVision AIOL in one eye during cataract surgery. Only one eye was treated.
Contralateral	AcrySof IQ monofocal IOL	Implantation with the FluidVision AIOL in the first eye during cataract surgery, followed by implantation with the AcrySof IQ monofocal IOL in the fellow eye during a subsequent cataract surgery
Contralateral	Cataract surgery	Implantation with the FluidVision AIOL in the first eye during cataract surgery, followed by implantation with the AcrySof IQ monofocal IOL in the fellow eye during a subsequent cataract surgery
Contralateral	FluidVision AIOL	Implantation with the FluidVision AIOL in the first eye during cataract surgery, followed by implantation with the AcrySof IQ monofocal IOL in the fellow eye during a subsequent cataract surgery

Primary Outcome Measures

Name	Time	Method
Distance Corrected Visual Acuity	Month 6 postoperative	Visual acuity was measured with distance correction (plus or minus power) in place.
International Organization for Standardization (ISO)-defined Cumulative and Persistent Adverse Events for Posterior Chamber IOL	Up to Month 6 postoperative	Adverse events were categorized per ISO 11979-7: Ophthalmic Implants - Intraocular Lenses - Part 7: Clinical Investigations.
Accommodative Amplitude (AA)	Month 6 postoperative	Accommodative amplitude is the ability of the eye to change its focus from distant to near objects.

Secondary Outcome Measures

Name	Time	Method
Uncorrected Visual Acuity	Up to Month 6 postoperative	Visual acuity was measured without correction in place.
Minimum Add Power Required to Achieve Best Corrected Near Visual Acuity	Up to Month 6 postoperative	Plus lenses were placed over the subject's best distance manifest correction.
Accommodative Amplitude	Month 3 postoperative	Accommodative amplitude is a measure of the range of vision with good acuity.