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ORION: VisiOn Restoration With FluidVisION Accommodating Intraocular Lens (AIOL)

Sponsor
PowerVision (Industry)
Overall Status
Completed
CT.gov ID
NCT03925545
Collaborator
(none)
85
Enrollment
2
Arms
22.3
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: FluidVision AIOL
  • Device: AcrySof IQ monofocal IOL
  • Procedure: Cataract surgery
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
85 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Device Feasibility
Official Title:
VisiOn Restoration With the FluidVisION AIOL
Actual Study Start Date :
Jan 17, 2017
Actual Primary Completion Date :
Nov 27, 2018
Actual Study Completion Date :
Nov 27, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Unilateral

Implantation with the FluidVision AIOL in one eye during cataract surgery. Only one eye was treated.

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

Procedure: Cataract surgery
Standard cataract extraction with phacoemulsification
Experimental: Contralateral

Implantation with the FluidVision AIOL in the first eye during cataract surgery, followed by implantation with the AcrySof IQ monofocal IOL in the fellow eye during a subsequent cataract surgery

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

Device: AcrySof IQ monofocal IOL
Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject

Procedure: Cataract surgery
Standard cataract extraction with phacoemulsification

Outcome Measures

Primary Outcome Measures

  1. Accommodative Amplitude (AA) [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 [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 [Up to Month 6 postoperative]

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

Secondary Outcome Measures

  1. Accommodative Amplitude [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 [Up to Month 6 postoperative]

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

  3. Uncorrected Visual Acuity [Up to Month 6 postoperative]

    Visual acuity was measured without correction in place.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • PowerVision

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
PowerVision
ClinicalTrials.gov Identifier:
NCT03925545
Other Study ID Numbers:
  • CTP07700
First Posted:
Apr 24, 2019
Last Update Posted:
May 21, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of May 21, 2021