Back to resultsVisiOn Restoration With FluidVisION Accommodating Intraocular Lens (AIOL) (ORION)
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FluidVision AIOL
AcrySof IQ monofocal IOL
Cataract surgery
Sponsored by
About this trial
This is an interventional device feasibility trial for Cataract
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Unilateral
Contralateral
Arm Description
Implantation with the FluidVision AIOL in one eye during cataract surgery. Only one eye was treated.
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
Outcomes
Primary Outcome Measures
Accommodative Amplitude (AA)
Accommodative amplitude is the ability of the eye to change its focus from distant to near objects.
Distance Corrected Visual Acuity
Visual acuity was measured with distance correction (plus or minus power) in place.
International Organization for Standardization (ISO)-defined Cumulative and Persistent Adverse Events for Posterior Chamber IOL
Adverse events were categorized per ISO 11979-7: Ophthalmic Implants - Intraocular Lenses - Part 7: Clinical Investigations.
Secondary Outcome Measures
Accommodative Amplitude
Accommodative amplitude is a measure of the range of vision with good acuity.
Minimum Add Power Required to Achieve Best Corrected Near Visual Acuity
Plus lenses were placed over the subject's best distance manifest correction.
Uncorrected Visual Acuity
Visual acuity was measured without correction in place.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03925545
Brief Title
VisiOn Restoration With FluidVisION Accommodating Intraocular Lens (AIOL)
Acronym
ORION
Official Title
VisiOn Restoration With the FluidVisION AIOL
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 17, 2017 (Actual)
Primary Completion Date
November 27, 2018 (Actual)
Study Completion Date
November 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PowerVision
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Unilateral
Arm Type
Experimental
Arm Description
Implantation with the FluidVision AIOL in one eye during cataract surgery. Only one eye was treated.
Arm Title
Contralateral
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
FluidVision AIOL
Intervention Description
Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject
Intervention Type
Device
Intervention Name(s)
AcrySof IQ monofocal IOL
Intervention Description
Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Intervention Description
Standard cataract extraction with phacoemulsification
Primary Outcome Measure Information:
Title
Accommodative Amplitude (AA)
Description
Accommodative amplitude is the ability of the eye to change its focus from distant to near objects.
Time Frame
Month 6 postoperative
Title
Distance Corrected Visual Acuity
Description
Visual acuity was measured with distance correction (plus or minus power) in place.
Time Frame
Month 6 postoperative
Title
International Organization for Standardization (ISO)-defined Cumulative and Persistent Adverse Events for Posterior Chamber IOL
Description
Adverse events were categorized per ISO 11979-7: Ophthalmic Implants - Intraocular Lenses - Part 7: Clinical Investigations.
Time Frame
Up to Month 6 postoperative
Secondary Outcome Measure Information:
Title
Accommodative Amplitude
Description
Accommodative amplitude is a measure of the range of vision with good acuity.
Time Frame
Month 3 postoperative
Title
Minimum Add Power Required to Achieve Best Corrected Near Visual Acuity
Description
Plus lenses were placed over the subject's best distance manifest correction.
Time Frame
Up to Month 6 postoperative
Title
Uncorrected Visual Acuity
Description
Visual acuity was measured without correction in place.
Time Frame
Up to Month 6 postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
VisiOn Restoration With FluidVisION Accommodating Intraocular Lens (AIOL)
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