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OpenTrials
Completed

NCT Number: NCT03508778

Clinical Evaluation of the FluidVision Accommodation Intraocular Lens (AIOL)

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PowerVision Investigative Site

Somerset West, 7130, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FluidVision AIOL

Device

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

AcrySof IQ PanOptix Trifocal IOL

Device

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

Other names: PanOptix

cataract surgery

Procedure

Cataract surgery per investigator's standard practice

Primary outcomes

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

    Time frame: Month 6 postoperative

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

Secondary outcomes

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

    Time frame: Month 6 postoperative

    Visual acuity was tested at a distance of 66 centimeters with distance correction (plus or minus power) in place.

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

    Time frame: Month 6 postoperative

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

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

    Time frame: Month 6 postoperative

    A series of plus and minus lenses were placed over the subject's best distance manifest correction to simulate distances from far to hear.

Sponsors and collaborators

Lead sponsor

PowerVision

Industry

Registry information

Official study title

CLinical Evaluation of the FluidVision AIOL for Accommodation Restoration

Acronym: CLEAR

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 26, 2018
Registry last updated
May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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