CataractORIONNCT03925545
VisiOn Restoration With FluidVisION Accommodating Intraocular Lens (AIOL)
A study testing FluidVision AIOL, AcrySof IQ monofocal IOL and Cataract surgery in people with Cataract, run by PowerVision.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- FluidVision AIOL, AcrySof IQ monofocal IOL and Cataract surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- 17 Jan 2017to 27 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: VisiOn Restoration With the FluidVisION 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.
Read the 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.
- Conditions
- Cataract
- Being tested
- FluidVision AIOL, AcrySof IQ monofocal IOL, Cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluidVision AIOLDevice
Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject
AcrySof IQ monofocal IOLDevice
Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject
Cataract surgeryProcedure or surgery
Standard cataract extraction with phacoemulsification
| Study group | Role | What they receive |
|---|---|---|
| Unilateral | Experimental | Implantation with the FluidVision AIOL in one eye during cataract surgery. Only one eye was treated. Receives: Device: FluidVision AIOL; Procedure: Cataract surgery |
| Contralateral | Experimental | 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 Receives: Device: FluidVision AIOL; Device: AcrySof IQ monofocal IOL; Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accommodative Amplitude (AA)
Accommodative amplitude is the ability of the eye to change its focus from distant to near objects.
Measured: Month 6 postoperative
Distance Corrected Visual Acuity
Visual acuity was measured with distance correction (plus or minus power) in place.
Measured: Month 6 postoperative
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.
Measured: Up to Month 6 postoperative
Secondary outcomes (3)
Accommodative Amplitude
Accommodative amplitude is a measure of the range of vision with good acuity.
Measured: Month 3 postoperative
Minimum Add Power Required to Achieve Best Corrected Near Visual Acuity
Plus lenses were placed over the subject's best distance manifest correction.
Measured: Up to Month 6 postoperative
Uncorrected Visual Acuity
Visual acuity was measured without correction in place.
Measured: Up to Month 6 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start17 Jan 2017
- Primary completion27 Nov 2018
- Study completion27 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- PowerVision
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925545
- Sponsor's protocol ID
- CTP07700
- Acronym
- ORION
- Status last verified
- May 2021
- First submitted
- 15 Apr 2019
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VisiOn Restoration With the FluidVisION AIOL
- ClinicalTrials.gov ID
- NCT03925545
- Acronym / sponsor ID
- ORION / CTP07700
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- PowerVisionIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 27 Nov 2018 (actual)
- Study completion
- 27 Nov 2018 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral | Experimental | Device: FluidVision AIOL, Procedure: Cataract surgeryImplantation with the FluidVision AIOL in one eye during cataract surgery. Only one eye was treated. |
| Contralateral | Experimental | Device: FluidVision AIOL, Device: AcrySof IQ monofocal IOL, Procedure: Cataract surgeryImplantation 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluidVision AIOLInvestigational implantable medical device intended for long-term use over the lifetime of the cataract subject | Device | Contralateral, Unilateral |
| AcrySof IQ monofocal IOLCommercially available implantable medical device intended for long-term use over the lifetime of the cataract subject | Device | Contralateral |
| Cataract surgeryStandard cataract extraction with phacoemulsification | Procedure or surgery | Contralateral, Unilateral |
Primary outcome
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.
Distance Corrected Visual Acuity
Time frame: Month 6 postoperative
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
Time frame: Up to Month 6 postoperative
Adverse events were categorized per ISO 11979-7: Ophthalmic Implants - Intraocular Lenses - Part 7: Clinical Investigations.
3 secondary outcomes
Accommodative Amplitude
Time frame: Month 3 postoperative
Minimum Add Power Required to Achieve Best Corrected Near Visual Acuity
Time frame: Up to Month 6 postoperative
Uncorrected Visual Acuity
Time frame: Up to Month 6 postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing FluidVision AIOL, AcrySof IQ monofocal IOL and Cataract surgery in people with Cataract, run by PowerVision.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accommodative Amplitude (AA) (time frame: Month 6 postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.