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OpenTrials
Completed

NCT Number: NCT03925545

VisiOn Restoration With FluidVisION Accommodating Intraocular Lens (AIOL)

The objective of this study is to obtain an initial assessment of the safety and performance of an investigational AIOL in patients 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

About this study

This study was originally designed as a single arm, unilateral study (one eye, one product only) to obtain an initial assessment of the safety and performance of an investigational IOL in subjects undergoing cataract extraction and IOL implantation. The study design was later modified to a contralateral study (both eyes, different product in each eye) to compare the safety and performance of the investigational IOL to a commercially available monofocal IOL.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Corrected distance visual acuity (CDVA) worse than 20/40, or presence of visually significant lens opacity;
  • Preoperative or predicted postoperative astigmatism of ≤ 1.0 diopter (D);
  • Calculated IOL power within range.

Key Exclusion Criteria:

  • Current medication that may affect accommodation;
  • Systemic disease or concomitant medication that may increase operative risk or confound results;
  • Ocular conditions that may predispose the subject for future complications;
  • Monocular subjects or subjects with significant permanent visual function loss in fellow eye;
  • Previous intraocular or corneal surgery in either eye that may confound the results or increase the risk to the subject, including implantation of a multifocal IOL or other presbyopic corrective surgery in the fellow eye;
  • Grade 4 cataract of any type.

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 monofocal IOL

Device

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

cataract surgery

Procedure

Standard cataract extraction with phacoemulsification

Primary outcomes

  1. Accommodative Amplitude (AA)

    Time frame: Month 6 postoperative

    Accommodative amplitude is the ability of the eye to change its focus from distant to near objects.

  2. Distance Corrected Visual Acuity

    Time frame: Month 6 postoperative

    Visual acuity was measured with distance correction (plus or minus power) in place.

  3. International Organization for Standardization (ISO)-defined Cumulative and Persistent Adverse Events for Posterior Chamber IOL

    Time frame: Up to Month 6 postoperative

    Adverse events were categorized per ISO 11979-7: Ophthalmic Implants - Intraocular Lenses - Part 7: Clinical Investigations.

Secondary outcomes

  1. Accommodative Amplitude

    Time frame: Month 3 postoperative

    Accommodative amplitude is a measure of the range of vision with good acuity.

  2. Minimum Add Power Required to Achieve Best Corrected Near Visual Acuity

    Time frame: Up to Month 6 postoperative

    Plus lenses were placed over the subject's best distance manifest correction.

  3. Uncorrected Visual Acuity

    Time frame: Up to Month 6 postoperative

    Visual acuity was measured without correction in place.

Sponsors and collaborators

Lead sponsor

PowerVision

Industry

Registry information

Official study title

VisiOn Restoration With the FluidVisION AIOL

Acronym: ORION

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 24, 2019
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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