NCT03925545

VisiOn Restoration With FluidVisION Accommodating Intraocular Lens (AIOL)

VisiOn Restoration With the FluidVisION AIOL

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: PowerVision · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	FluidVision AIOL	Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject
DEVICE	AcrySof IQ monofocal IOL	Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject
PROCEDURE	Cataract surgery	Standard cataract extraction with phacoemulsification

Timeline

• Start date: 2017-01-17
• Primary completion: 2018-11-27
• Completion: 2018-11-27
• First posted: 2019-04-24
• Last updated: 2021-05-21

Regulatory

• FDA-regulated device study