AphakiaNCT02049567
Clinical Evaluation of the FluidVision Accommodating Intraocular Lens (AIOL)
A study testing FluidVision AIOL and Cataract Surgery in people with Aphakia, run by PowerVision at 8 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of an investigational IOL. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Aphakia
- What is being tested?
- FluidVision AIOL 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
- 170 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 14 Jan 2014to 6 Nov 2017
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Germany4 sites
PowerVision Investigative Site
Berlin, 10559
PowerVision Investigative Site
Bochum, North Rhine-Westphalia, 44892
PowerVision Investigative Site
Heidelberg, Baden-Wurttemberg, D-69120
PowerVision Investigative Site
Stuttgart, Baden-Wurttemberg, D-70176
South Africa4 sites
PowerVision Investigative Site
Claremont, Cape Town, 7708
PowerVision Investigative Site
Northcliff, Johannesburg, 2195
PowerVision Investigative Site
Paardevlei, Somerset West, 7130
PowerVision Investigative Site
Queenswood, Pretoria, 2001
About this study
Official title: Clinical Evaluation of the FluidVision Accommodating Intraocular Lens
The purpose of this study is to evaluate the safety and effectiveness of an investigational IOL.
Read the detailed description
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.
- Conditions
- Aphakia
- Being tested
- FluidVision AIOL, Cataract Surgery
- Keywords
- Cataract
- Medical subject headings
- Aphakia, 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
Cataract SurgeryProcedure or surgery
Performed using standard microsurgical techniques
| Study group | Role | What they receive |
|---|---|---|
| FluidVision | Experimental | FluidVision AIOL implanted in the capsular bag of the eye during cataract surgery Receives: Device: FluidVision AIOL; Procedure: Cataract Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accommodative amplitude
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.
Measured: Month 6
Best corrected distance visual acuity (BCDVA)
Visual acuity of the eye will be tested with the correction in place.
Measured: Month 6
Rates of adverse events
Adverse events will be collected from time of enrollment to study exit
Measured: Up to Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study start14 Jan 2014
- Primary completion24 Jun 2015
- Study completion6 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphakiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- PowerVision
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049567
- Sponsor's protocol ID
- AIOL-2009-1
- Status last verified
- May 2021
- First submitted
- 28 Jan 2014
- 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
- Clinical Evaluation of the FluidVision Accommodating Intraocular Lens
- ClinicalTrials.gov ID
- NCT02049567
- Acronym / sponsor ID
- AIOL-2009-1
- Conditions
- Aphakia
- Keywords
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- PowerVisionIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2014 (actual)
- Primary completion
- 24 Jun 2015 (actual)
- Study completion
- 6 Nov 2017 (actual)
- First posted
- 30 Jan 2014 (estimated)
- 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 purpose of this study is to evaluate the safety and effectiveness of an investigational IOL.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FluidVision | Experimental | Device: FluidVision AIOL, Procedure: Cataract SurgeryFluidVision AIOL implanted in the capsular bag of the eye during cataract surgery |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (7 listed)
- 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;
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 | FluidVision |
| Cataract SurgeryPerformed using standard microsurgical techniques | Procedure or surgery | FluidVision |
Primary outcome
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.
Best corrected distance visual acuity (BCDVA)
Time frame: Month 6
Visual acuity of the eye will be tested with the correction in place.
Rates of adverse events
Time frame: Up to Month 36
Adverse events will be collected from time of enrollment to study exit
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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Clareon TruPlus Study
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Clinical Evaluation of a Novel Trifocal IOL
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Contralateral Claims Study of Clareon Vivity Pro
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Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL
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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.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FluidVision AIOL and Cataract Surgery in people with Aphakia, run by PowerVision at 8 sites in 2 countries.
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 5 inclusion and 7 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.
Where is the study taking place?
The record lists 8 sites in Germany, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
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 (time frame: Month 6). 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.