Clinical Evaluation of the FluidVision Accommodation Intraocular Lens (AIOL)

Cataract Clinical Trial

— CLEAR  

Official title:

CLinical Evaluation of the FluidVision AIOL for Accommodation Restoration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03508778
• Other study ID #: CTP08239
• Status: Completed
• Phase: N/A
• Start date: February 27, 2018
• Est. completion date: December 6, 2019

Study information

• Verified date: May 2021
• Source: PowerVision
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: December 6, 2019
• Est. primary completion date: June 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• FluidVision AIOL
Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject
• 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

Locations

Country	Name	City	State
South Africa	PowerVision Investigative Site	Somerset West

Sponsors (1)

Lead Sponsor	Collaborator
PowerVision

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Distance Corrected Intermediate Visual Acuity (DCIVA) at 100% Contrast - First Implanted Eye	Visual acuity was tested at a distance of 66 centimeters with distance correction (plus or minus power) in place.	Month 6 postoperative
Secondary	Distance Corrected Near Visual Acuity (DCNVA) at low 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	Percentage of Eyes with 20/32 or Better Visual Acuity Between 4 meters and 40 centimeters on the Defocus Curve	A series of plus and minus lenses were placed over the subject's best distance manifest correction to simulate distances from far to hear.	Month 6 postoperative