NCT03508778

Clinical Evaluation of the FluidVision Accommodation Intraocular Lens (AIOL)

CLinical Evaluation of the FluidVision AIOL for Accommodation Restoration

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: PowerVision · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

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 PanOptix Trifocal IOL	Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject
PROCEDURE	Cataract surgery	Cataract surgery per investigator's standard practice

Timeline

• Start date: 2018-02-27
• Primary completion: 2019-06-11
• Completion: 2019-12-06
• First posted: 2018-04-26
• Last updated: 2021-05-24

Locations

1 site across 1 country: South Africa

Regulatory

• FDA-regulated device study