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OpenTrials
Completed

NCT Number: NCT02049567

Clinical Evaluation of the FluidVision Accommodating Intraocular Lens (AIOL)

The purpose of this study is to evaluate the safety and effectiveness of an investigational IOL.

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Key information

Conditions

Aphakia 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, Heidelberg, Baden-Wurttemberg, Germany

Loading trial locations.

About this study

Eligible subjects will receive the investigational IOL in one eye and be followed at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months and 36 months post-operation.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Eligible for primary intraocular lens implantation for the correction of aphakia following cataract extraction;
  • Best corrected distance visual acuity worse than 20/40 either with or without a glare source present (e.g. Brightness Acuity Tester);
  • Less than or equal to 1.0 diopter (D) of preoperative keratometric astigmatism;
  • Willing and able to comply with schedule for follow-up visits for 36 months after surgery.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • Systemic disease that could increase the operative risk or confound the outcome (e.g. autoimmune disease, diabetes);
  • Taking systemic medications that may confound the outcome or increase the risk to the subject;
  • Ocular conditions that may predispose for future complications;
  • Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject;
  • Pregnant, lactating during the course of the investigation, or with another condition associated with fluctuation of hormones that could lead to refractive changes;
  • Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future best corrected visual acuity loss worse than 20/40.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

FluidVision AIOL

Device

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

cataract surgery

Procedure

Performed using standard microsurgical techniques

Primary outcomes

  1. Accommodative amplitude

    Time frame: Month 6

    Accommodative amplitude is a measure of the ability of the eye to focus from a target that is at distance into a target that is near.

  2. Best corrected distance visual acuity (BCDVA)

    Time frame: Month 6

    Visual acuity of the eye will be tested with the correction in place.

  3. Rates of adverse events

    Time frame: Up to Month 36

    Adverse events will be collected from time of enrollment to study exit

Sponsors and collaborators

Lead sponsor

PowerVision

Industry

Registry information

Official study title

Clinical Evaluation of the FluidVision Accommodating Intraocular Lens

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Jan 30, 2014
Registry last updated
May 21, 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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