AphakiaNCT04542525
Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens
A study testing ACRYSOF IQ PanOptix Toric Trifocal IOL and Cataract surgery in people with Aphakia and Corneal Astigmatism, run by Alcon Research at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of the TFNT20 low cylinder power intraocular lens when implanted in the eye to replace the natural lens following cataract removal. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Aphakia, Corneal Astigmatism
- What is being tested?
- ACRYSOF IQ PanOptix Toric 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
- 32 participants
- Where
- 1 siteJapan
- Study dates
- 1 Dec 2020to 10 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible to be implanted with AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20 in at least one eye.
- Potential postoperative Best Corrected Distance Visual Acuity (BCDVA) of 0.5 decimal or better.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Irregular corneal astigmatism.
- History of anterior segment, posterior segment, or optic nerve pathology.
- History of previous intraocular or corneal (refractive or trauma related) surgery.
- Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI)/Astigmatic Keratotomy and laser assisted in situ keratomileusis (LASIK).
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Investigation of AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20
The purpose of this study is to evaluate the effectiveness and safety of the TFNT20 low cylinder power intraocular lens when implanted in the eye to replace the natural lens following cataract removal.
Read the detailed description
Subjects will attend a total of 5 to 9 visits, depending on whether one eye or both eyes are implanted. The second eye surgery, if applicable, will occur 1 to 30 days after the first eye surgery. Total individual duration of participation will be up to 4 months, including an up to 2-month preoperative period.
This study will be conducted in Japan.
- Conditions
- Aphakia, Corneal Astigmatism
- Being tested
- ACRYSOF IQ PanOptix Toric Trifocal IOL, Cataract surgery
- Keywords
- Cataract, Intraocular lens, Astigmatism, Toric
- Medical subject headings
- Aphakia, Astigmatism, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACRYSOF IQ PanOptix Toric Trifocal IOLDevice
Also called PanOptix Toric Trifocal IOL, Model TFNT20
Single-piece, ultraviolet and blue-light filtering, foldable, multifocal toric IOL intended to provide vision to aphakic subjects at near, intermediate, and distance and to correct pre-existing corneal astigmatism
Cataract surgeryProcedure or surgery
Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use
| Study group | Role | What they receive |
|---|---|---|
| PanOptix Toric Trifocal IOL | Experimental | ACRYSOF IQ PanOptix Toric Trifocal IOL Model TFNT20 implanted in the capsular bag in the posterior chamber following cataract surgery. At least one eye will be implanted. Receives: Device: ACRYSOF IQ PanOptix Toric Trifocal IOL; Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)
A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism.
Measured: Day 30-60 postoperative
Secondary outcomes (2)
Percentage of Eyes With ≤ 0.5 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)
A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. No confirmatory statistical hypothesis testing was pre-specified in the protocol.
Measured: Day 30-60 postoperative
Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60)
A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. No confirmatory statistical hypothesis testing was pre-specified in the protocol.
Measured: Day 30-60 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 Dec 2020
- Primary completion10 Aug 2021
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AphakiaStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Clinical Trial Lead, CDMA Surgical, Study director, Alcon Japan Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542525
- Sponsor's protocol ID
- ILX140-C001
- Status last verified
- Jul 2022
- First submitted
- 3 Sep 2020
- Last updated
- 17 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20
- ClinicalTrials.gov ID
- NCT04542525
- Acronym / sponsor ID
- ILX140-C001
- Conditions
- Aphakia, Corneal Astigmatism
- Keywords
- Cataract, Intraocular lens, Astigmatism, Toric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Posted 17 Aug 2022
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 effectiveness and safety of the TFNT20 low cylinder power intraocular lens when implanted in the eye to replace the natural lens following cataract removal.
Detailed description
Subjects will attend a total of 5 to 9 visits, depending on whether one eye or both eyes are implanted. The second eye surgery, if applicable, will occur 1 to 30 days after the first eye surgery. Total individual duration of participation will be up to 4 months, including an up to 2-month preoperative period.
This study will be conducted in Japan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PanOptix Toric Trifocal IOL | Experimental | Device: ACRYSOF IQ PanOptix Toric Trifocal IOL, Procedure: Cataract surgeryACRYSOF IQ PanOptix Toric Trifocal IOL Model TFNT20 implanted in the capsular bag in the posterior chamber following cataract surgery. At least one eye will be implanted. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eligible to be implanted with AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20 in at least one eye.
- Potential postoperative Best Corrected Distance Visual Acuity (BCDVA) of 0.5 decimal or better.
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (5 listed)
- Irregular corneal astigmatism.
- History of anterior segment, posterior segment, or optic nerve pathology.
- History of previous intraocular or corneal (refractive or trauma related) surgery.
- Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI)/Astigmatic Keratotomy and laser assisted in situ keratomileusis (LASIK).
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| ACRYSOF IQ PanOptix Toric Trifocal IOLAlso: PanOptix Toric Trifocal IOL, Model TFNT20Single-piece, ultraviolet and blue-light filtering, foldable, multifocal toric IOL intended to provide vision to aphakic subjects at near, intermediate, and distance and to correct pre-existing corneal astigmatism | Device | PanOptix Toric Trifocal IOL |
| Cataract surgeryCataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use | Procedure or surgery | PanOptix Toric Trifocal IOL |
Primary outcome
Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)
Time frame: Day 30-60 postoperative
A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism.
2 secondary outcomes
Percentage of Eyes With ≤ 0.5 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)
Time frame: Day 30-60 postoperative
Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60)
Time frame: Day 30-60 postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Sr. Clinical Trial Lead, CDMA Surgical study director
Alcon Japan Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACRYSOF IQ PanOptix Toric Trifocal IOL and Cataract surgery in people with Aphakia and Corneal Astigmatism, run by Alcon Research at 1 site in Japan.
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 17 Aug 2022. 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 Japan. 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?
Yes. Results are posted in the registry (first posted 17 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60) (time frame: Day 30-60 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 17 Aug 2022.