NCT03508778

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 5, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2019

Completed
Last Updated

May 24, 2021

Status Verified

May 1, 2021

Enrollment Period

1.3 years

First QC Date

April 5, 2018

Last Update Submit

May 21, 2021

Conditions

Cataract

Keywords

Intraocular lensEye surgery

Outcome Measures

Primary Outcomes (1)

  • Distance Corrected Near Visual Acuity (DCNVA) at 100% Contrast - First Implanted Eye

    Visual acuity was tested at a distance of 40 centimeters with distance correction (plus or minus power) in place.

    Month 6 postoperative

Secondary Outcomes (3)

  • Distance Corrected Intermediate Visual Acuity (DCIVA) at 100% Contrast - First Implanted Eye

    Month 6 postoperative

  • Distance Corrected Near Visual Acuity (DCNVA) at low contrast - First Implanted Eye

    Month 6 postoperative

  • Percentage of Eyes with 20/32 or Better Visual Acuity Between 4 meters and 40 centimeters on the Defocus Curve

    Month 6 postoperative

Study Arms (2)

FluidVision

EXPERIMENTAL

FluidVision AIOL implanted in the capsular bag of the eye during cataract surgery. Both eyes were implanted, with the second eye surgery occurring after the Week 1 follow up for the first eye surgery.

Device: FluidVision AIOLProcedure: Cataract surgery

PanOptix

ACTIVE COMPARATOR

Commercially available trifocal IOL implanted in the capsular bag of the eye during cataract surgery. Both eyes were implanted, with the second eye surgery occurring after the Week 1 follow up for the first eye surgery.

Device: AcrySof IQ PanOptix Trifocal IOLProcedure: Cataract surgery

Interventions

FluidVision AIOLDEVICE

Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject

FluidVision
AcrySof IQ PanOptix Trifocal IOLDEVICE

Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject

Also known as: PanOptix
PanOptix
Cataract surgeryPROCEDURE

Cataract surgery per investigator's standard practice

FluidVisionPanOptix

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Require cataract extraction by phacoemulsification;
  • Corrected Distance Visual Acuity (CDVA) worse than 20/40 Snellen, or presence of visually significant lens opacity;
  • Preoperative or predicted postoperative astigmatism of ≤ 1.0 diopter.

You may not qualify if:

  • Use of current medications that may affect accommodation or confound study results;
  • Systemic disease that may increase the operative risk or confound results;
  • Ocular conditions or degenerative disorders that may predispose the subject to future complications;
  • Monocular subjects or significant permanent visual function loss in 1 eye;
  • Previous ocular surgery in either eye that may confound the results or increase the risk to the subject.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PowerVision Investigative Site

Somerset West, 7130, South Africa

Location

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2018

First Posted

April 26, 2018

Study Start

February 27, 2018

Primary Completion

June 11, 2019

Study Completion

December 6, 2019

Last Updated

May 24, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)