CataractCLEARNCT03508778
Clinical Evaluation of the FluidVision Accommodation Intraocular Lens (AIOL)
A study testing FluidVision AIOL, AcrySof IQ PanOptix Trifocal IOL and Cataract surgery in people with Cataract, run by PowerVision at 1 site in South Africa.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of an investigational IOL in providing a range of vision as compared to a commercially available trifocal IOL in subjects 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 PanOptix Trifocal 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
- 95 participants
- Where
- 1 siteSouth Africa
- Study dates
- 27 Feb 2018to 6 Dec 2019
- 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
- Require cataract extraction by phacoemulsification;
- Corrected Distance Visual Acuity (CDVA) worse than 20/40 Snellen, or presence of visually significant lens opacity;
- Preoperative or predicted postoperative astigmatism of ≤ 1.0 diopter.
Who cannot join
- Use of current medications that may affect accommodation or confound study results;
- Systemic disease that may increase the operative risk or confound results;
- Ocular conditions or degenerative disorders that may predispose the subject to future complications;
- Monocular subjects or significant permanent visual function loss in 1 eye;
- Previous ocular surgery in either eye that may confound the results or increase the risk to the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CLinical Evaluation of the FluidVision AIOL for Accommodation Restoration
The objective of this study is to evaluate the safety and effectiveness of an investigational IOL in providing a range of vision as compared to a commercially available trifocal IOL in subjects undergoing cataract extraction and IOL implantation.
Read the detailed description
Upon obtaining written informed consent and confirmation of subject eligibility via preoperative assessments, subjects were randomized in a 1:1 ratio to receive either the investigational IOL or the commercially available trifocal IOL in both eyes. The second eye for each subject was implanted after completion of the 1-week follow up for the first implanted eye. The expected total duration of participation for each subject was up to 14 months.
- Conditions
- Cataract
- Being tested
- FluidVision AIOL, AcrySof IQ PanOptix Trifocal IOL, Cataract surgery
- Keywords
- Intraocular lens, Eye 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 PanOptix Trifocal IOLDevice
Also called PanOptix
Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject
Cataract surgeryProcedure or surgery
Cataract surgery per investigator's standard practice
| Study group | Role | What they receive |
|---|---|---|
| FluidVision | Experimental | FluidVision AIOL implanted in the capsular bag of the eye during cataract surgery. Both eyes were implanted, with the second eye surgery occurring after the Week 1 follow up for the first eye surgery. Receives: Device: FluidVision AIOL; Procedure: Cataract surgery |
| PanOptix | Active comparator | Commercially available trifocal IOL implanted in the capsular bag of the eye during cataract surgery. Both eyes were implanted, with the second eye surgery occurring after the Week 1 follow up for the first eye surgery. Receives: Device: AcrySof IQ PanOptix Trifocal IOL; Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Corrected Near Visual Acuity (DCNVA) at 100% Contrast - First Implanted Eye
Visual acuity was tested at a distance of 40 centimeters with distance correction (plus or minus power) in place.
Measured: Month 6 postoperative
Secondary outcomes (3)
Distance Corrected Intermediate Visual Acuity (DCIVA) at 100% Contrast - First Implanted Eye
Visual acuity was tested at a distance of 66 centimeters with distance correction (plus or minus power) in place.
Measured: Month 6 postoperative
Distance Corrected Near Visual Acuity (DCNVA) at low contrast - First Implanted Eye
Visual acuity was tested at a distance of 40 centimeters with distance correction (plus or minus power) in place.
Measured: Month 6 postoperative
Percentage of Eyes with 20/32 or Better Visual Acuity Between 4 meters and 40 centimeters on the Defocus Curve
A series of plus and minus lenses were placed over the subject's best distance manifest correction to simulate distances from far to hear.
Measured: 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 posted26 Apr 2018
- Study start27 Feb 2018
- Primary completion11 Jun 2019
- Study completion6 Dec 2019
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- PowerVision
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508778
- Sponsor's protocol ID
- CTP08239
- Acronym
- CLEAR
- Status last verified
- May 2021
- First submitted
- 5 Apr 2018
- Last updated
- 24 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 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLinical Evaluation of the FluidVision AIOL for Accommodation Restoration
- ClinicalTrials.gov ID
- NCT03508778
- Acronym / sponsor ID
- CLEAR / CTP08239
- Conditions
- Cataract
- Keywords
- Intraocular lens, Eye surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- PowerVisionIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 11 Jun 2019 (actual)
- Study completion
- 6 Dec 2019 (actual)
- First posted
- 26 Apr 2018 (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 evaluate the safety and effectiveness of an investigational IOL in providing a range of vision as compared to a commercially available trifocal IOL in subjects undergoing cataract extraction and IOL implantation.
Detailed description
Upon obtaining written informed consent and confirmation of subject eligibility via preoperative assessments, subjects were randomized in a 1:1 ratio to receive either the investigational IOL or the commercially available trifocal IOL in both eyes. The second eye for each subject was implanted after completion of the 1-week follow up for the first implanted eye. The expected total duration of participation for each subject was up to 14 months.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FluidVision | Experimental | Device: FluidVision AIOL, Procedure: Cataract surgeryFluidVision AIOL implanted in the capsular bag of the eye during cataract surgery. Both eyes were implanted, with the second eye surgery occurring after the Week 1 follow up for the first eye surgery. |
| PanOptix | Active comparator | Device: AcrySof IQ PanOptix Trifocal IOL, Procedure: Cataract surgeryCommercially available trifocal IOL implanted in the capsular bag of the eye during cataract surgery. Both eyes were implanted, with the second eye surgery occurring after the Week 1 follow up for the first eye 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)
- Require cataract extraction by phacoemulsification;
- Corrected Distance Visual Acuity (CDVA) worse than 20/40 Snellen, or presence of visually significant lens opacity;
- Preoperative or predicted postoperative astigmatism of ≤ 1.0 diopter.
Key exclusion criteria (5 listed)
- Use of current medications that may affect accommodation or confound study results;
- Systemic disease that may increase the operative risk or confound results;
- Ocular conditions or degenerative disorders that may predispose the subject to future complications;
- Monocular subjects or significant permanent visual function loss in 1 eye;
- Previous ocular surgery in either eye that may confound the results or increase the risk to the subject.
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 |
| AcrySof IQ PanOptix Trifocal IOLAlso: PanOptixCommercially available implantable medical device intended for long-term use over the lifetime of the cataract subject | Device | PanOptix |
| Cataract surgeryCataract surgery per investigator's standard practice | Procedure or surgery | FluidVision, PanOptix |
Primary outcome
Distance Corrected Near Visual Acuity (DCNVA) at 100% Contrast - First Implanted Eye
Time frame: Month 6 postoperative
Visual acuity was tested at a distance of 40 centimeters with distance correction (plus or minus power) in place.
3 secondary outcomes
Distance Corrected Intermediate Visual Acuity (DCIVA) at 100% Contrast - First Implanted Eye
Time frame: Month 6 postoperative
Distance Corrected Near Visual Acuity (DCNVA) at low contrast - First Implanted Eye
Time frame: Month 6 postoperative
Percentage of Eyes with 20/32 or Better Visual Acuity Between 4 meters and 40 centimeters on the Defocus Curve
Time frame: 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 24 May 2021.
- Individual participant dataSharing planned: No
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FluidVision AIOL, AcrySof IQ PanOptix Trifocal IOL and Cataract surgery in people with Cataract, run by PowerVision at 1 site in South Africa.
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 5 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 24 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 1 site in 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?
Distance Corrected Near Visual Acuity (DCNVA) at 100% Contrast - First Implanted Eye (time frame: Month 6 postoperative). 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 24 May 2021.