AphakiaNCT04330001
Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL
A study testing Alcon Fluid Accommodating Intraocular Lens and Top Con Autorefractor in people with Aphakia and Presbyopia, run by Alcon Research at 2 sites in 2 countries.
Trial summary
The purpose of this clinical study is to assess the repeatability of objective refraction using auto refraction on subjects bilaterally implanted (implanted in both eyes) with the Fluid Accommodating IOL (FAIOL). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Aphakia, Presbyopia
- What is being tested?
- Alcon Fluid Accommodating Intraocular Lens and Top Con Autorefractor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Dec 2020to 3 May 2023
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to attend all scheduled study visits as required per protocol
- 22 years of age or older
- Bilateral cataracts
- Corneal astigmatism ≤ 1.25 D
- Clear intraocular media other than cataract
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Women of childbearing potential, defined as all women who are physiologically capable of becoming pregnant and who are not postmenopausal for at least 1 year or are less than 6 weeks since sterilization, are excluded from participation if any of the following apply:
- are currently pregnant,
- have a positive urine pregnancy test result at V0,
- intend to become pregnant during the study period,
- are breast-feeding.
- Subjects taking medications that may affect accommodation, confound the outcome, or as per the Investigator's opinion may increase the risk to the subject
Show all 12Show fewer
- Glaucoma
- Significant corneal or retinal abnormalities, per the Investigator's opinion, or other disease or pathology other than cataract expected to reduce postoperative vision
- Monocular patient, significant permanent visual function loss, or binocular vision anomalies as evaluated by specific testing
- Previous corneal procedure (such as LASIK, keratotomy, LRI) or plans to have additional corneal procedures during the study
- Systemic disease that could increase the operative risk or confound the outcome
- Other protocol-specified exclusion criteria may apply
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The purpose of this clinical study is to assess the repeatability of objective refraction using auto refraction on subjects bilaterally implanted (implanted in both eyes) with the Fluid Accommodating IOL (FAIOL).
Read the detailed description
Subjects will be expected to attend 10 office visits from screening to exit. The total expected duration of participation for each subject in this study is approximately 12 months. The second eye surgery will take place within 7-15 days from the date of the first implanted eye. The primary endpoint will be collected at Month 1, following the 2nd eye implant date.
- Conditions
- Aphakia, Presbyopia
- Being tested
- Alcon Fluid Accommodating Intraocular Lens, Top Con Autorefractor
- Keywords
- IOL, Cataract, Accommodation
- Medical subject headings
- Aphakia, Presbyopia, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcon Fluid Accommodating Intraocular LensDevice
Also called FAIOL, FluidVision MX Accommodating IOL
Intraocular lens intended to treat presbyopia by dynamically adjusting power, resulting in a continuous range of vision from distance to near.
Top Con AutorefractorOther
Device intended to automatically determine the focusing characteristics of the eye
| Study group | Role | What they receive |
|---|---|---|
| FAIOL | Experimental | Implantation of FAIOL in the capsular bag in the posterior chamber of the eye. The IOL is intended to be used over the lifetime of the subject. Receives: Device: Alcon Fluid Accommodating Intraocular Lens; Other: Top Con Autorefractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeatability of objective refraction
Two assessments of objective refraction (sphere, cylinder, and spherical equivalent) using auto refraction will be made on the same day. Repeatability of objective refraction will be evaluated using the Intra-class correlation coefficient (ICC), separately by eye. ICC is evaluated as the proportion of all variation that is not due to measurement error. Higher values of ICC indicate lower error variance and hence better repeatability. Repeatability of objective refraction will be assessed with and without cycloplegia (temporary paralysis of the ciliary muscle).
Measured: Month 1 (post 2nd eye implant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start28 Dec 2020
- Primary completion8 Jun 2022
- Study completion3 May 2023
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Operation Lead CDMA Surgical, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330001
- Sponsor's protocol ID
- ILR286-E003
- Status last verified
- May 2023
- First submitted
- 30 Mar 2020
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study for Techniques Associated With the Fluid Accommodating IOL
- ClinicalTrials.gov ID
- NCT04330001
- Acronym / sponsor ID
- ILR286-E003
- Conditions
- Aphakia, Presbyopia
- Keywords
- IOL, Cataract, Accommodation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 1 Apr 2020 (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 purpose of this clinical study is to assess the repeatability of objective refraction using auto refraction on subjects bilaterally implanted (implanted in both eyes) with the Fluid Accommodating IOL (FAIOL).
Detailed description
Subjects will be expected to attend 10 office visits from screening to exit. The total expected duration of participation for each subject in this study is approximately 12 months. The second eye surgery will take place within 7-15 days from the date of the first implanted eye. The primary endpoint will be collected at Month 1, following the 2nd eye implant date.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FAIOL | Experimental | Device: Alcon Fluid Accommodating Intraocular Lens, Other: Top Con AutorefractorImplantation of FAIOL in the capsular bag in the posterior chamber of the eye. The IOL is intended to be used over the lifetime of the subject. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing and able to attend all scheduled study visits as required per protocol
- 22 years of age or older
- Bilateral cataracts
- Corneal astigmatism ≤ 1.25 D
- Clear intraocular media other than cataract
Key exclusion criteria (12 listed)
- Women of childbearing potential, defined as all women who are physiologically capable of becoming pregnant and who are not postmenopausal for at least 1 year or are less than 6 weeks since sterilization, are excluded from participation if any of the following apply:
- Subjects taking medications that may affect accommodation, confound the outcome, or as per the Investigator's opinion may increase the risk to the subject
- Glaucoma
- Significant corneal or retinal abnormalities, per the Investigator's opinion, or other disease or pathology other than cataract expected to reduce postoperative vision
- Monocular patient, significant permanent visual function loss, or binocular vision anomalies as evaluated by specific testing
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 |
|---|---|---|
| Alcon Fluid Accommodating Intraocular LensAlso: FAIOL, FluidVision MX Accommodating IOLIntraocular lens intended to treat presbyopia by dynamically adjusting power, resulting in a continuous range of vision from distance to near. | Device | FAIOL |
| Top Con AutorefractorDevice intended to automatically determine the focusing characteristics of the eye | Other | FAIOL |
Primary outcome
Repeatability of objective refraction
Time frame: Month 1 (post 2nd eye implant)
Two assessments of objective refraction (sphere, cylinder, and spherical equivalent) using auto refraction will be made on the same day. Repeatability of objective refraction will be evaluated using the Intra-class correlation coefficient (ICC), separately by eye. ICC is evaluated as the proportion of all variation that is not due to measurement error. Higher values of ICC indicate lower error variance and hence better repeatability. Repeatability of objective refraction will be assessed with and without cycloplegia (temporary paralysis of the ciliary muscle).
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 6 May 2023.
- 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.
Clinical Operation Lead CDMA Surgical study director
Alcon Research
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcon Fluid Accommodating Intraocular Lens and Top Con Autorefractor in people with Aphakia and Presbyopia, run by Alcon Research at 2 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 6 inclusion and 12 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in El Salvador, Panama. 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?
Repeatability of objective refraction (time frame: Month 1 (post 2nd eye implant)). 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 6 May 2023; AzTrials last refreshed its copy on 27 Oct 2026.