VisiOn Restoration With FluidVisION Accommodating Intraocular Lens (AIOL) (ORION)

VisiOn Restoration With the FluidVisION AIOL

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: FluidVision AIOL; Procedure: Cataract surgery; Device: AcrySof IQ monofocal IOL

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 Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unilateral; Implantation with the FluidVision AIOL in one eye during cataract surgery. Only one eye was treated.	Device: FluidVision AIOL; Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject; Procedure: Cataract surgery; Standard cataract extraction with phacoemulsification
Experimental: Contralateral; 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	Device: FluidVision AIOL; Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject; Procedure: Cataract surgery; Standard cataract extraction with phacoemulsification; Device: AcrySof IQ monofocal IOL; Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: PowerVision

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2017
• Primary Completion (Actual): November 27, 2018
• Study Completion (Actual): November 27, 2018

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): May 21, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CTP07700

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes