Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00

A study testing AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL in people with Cataract, run by Alcon Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to investigate visual outcomes and assess safety at 12 months (330-420 days) post bilateral implantation of the AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Cataract
What is being tested?: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 167 participants
Where: No sites listed yet
Study dates: 7 Sep 2015to 26 Jun 2017
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 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision;
Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
Clear intraocular media other than cataract in both eyes;
Other protocol-specified inclusion criteria may apply.

Who cannot join

Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema;
Ocular trauma, corneal transplant, retinal conditions, degenerative eye disorders, or color vision deficiencies;
Glaucoma (uncontrolled or controlled with medication) or ocular hypertension;
Pregnant or lactating;
Expected to require ocular surgical or retinal laser treatment;
Other protocol-specified exclusion criteria may apply.

About this study

Official title: Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL Model TFNT00

The purpose of this study is to investigate visual outcomes and assess safety at 12 months (330-420 days) post bilateral implantation of the AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL.

Read the detailed description

This study will be conducted in regions where the test article is approved at the time of study start.

Conditions: Cataract
Being tested: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcrySof® IQ PanOptix™ Presbyopia-Correcting IOLDevice
Also called Model TFNT00
Multifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient

Study groups in NCT02529488
Study group	Role	What they receive
TFNT00	Experimental	AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation Receives: Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Binocular Defocus Visual Acuity (VA)
Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best spectacle correction at a distance of 4 meters. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. The defocus VA summaries are based on the number of subjects evaluable for Best-Case Analysis Set and have data available at the corresponding visit. No formal statistical hypothesis testing was planned.
Measured: Day 20-40 and Day 120-180 from second eye implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Sep 201526 Jun 2017

First posted20 Aug 2015 (estimated)
Study start7 Sep 2015
Primary completion30 Nov 2016
Study completion26 Jun 2017

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 CataractStudies 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: 167 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02529488
Sponsor's protocol ID: ILH297-P002
Status last verified: Mar 2018
First submitted: 19 Aug 2015
Last updated: 2 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL Model TFNT00
ClinicalTrials.gov ID: NCT02529488
Acronym / sponsor ID: ILH297-P002
Conditions: Cataract
Study type: Interventional
Recruitment status: Completed
Enrolment: 167 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 7 Sep 2015 (actual)
Primary completion: 30 Nov 2016 (actual)
Study completion: 26 Jun 2017 (actual)
First posted: 20 Aug 2015 (estimated)
Results: Posted 6 Apr 2018

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 investigate visual outcomes and assess safety at 12 months (330-420 days) post bilateral implantation of the AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL.

Detailed description

This study will be conducted in regions where the test article is approved at the time of study start.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TFNT00	Experimental	Device: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOLAcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Diagnosis of bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision;
Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
Clear intraocular media other than cataract in both eyes;
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (6 listed)

Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema;
Ocular trauma, corneal transplant, retinal conditions, degenerative eye disorders, or color vision deficiencies;
Glaucoma (uncontrolled or controlled with medication) or ocular hypertension;
Pregnant or lactating;
Expected to require ocular surgical or retinal laser treatment;

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™ Presbyopia-Correcting IOLAlso: Model TFNT00Multifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient	Device	TFNT00

Primary outcome

Mean Binocular Defocus Visual Acuity (VA)
Time frame: Day 20-40 and Day 120-180 from second eye implantation
Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best spectacle correction at a distance of 4 meters. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. The defocus VA summaries are based on the number of subjects evaluable for Best-Case Analysis Set and have data available at the corresponding visit. No formal statistical hypothesis testing was planned.

Results and safety

Results posted to the registry on 6 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TFNT00	149	145

Primary outcome: Mean Binocular Defocus Visual Acuity (VA)

Time frame: Day 20-40 and Day 120-180 from second eye implantation. Mean (Standard Deviation). Unit: logMAR

Measure	TFNT00 Visit 3A n = 137	TFNT00 Visit 4A n = 134
+2.00 Diopter (D)	0.570 (0.1893)	0.569 (0.1844)
+1.50D	0.404 (0.1610)	0.388 (0.1679)
+1.00D	0.209 (0.1386)	0.214 (0.1413)
+0.50D	0.069 (0.1438)	0.058 (0.1205)
0.00D	-0.030 (0.1155)	-0.037 (0.1069)
-0.50D	0.037 (0.1099)	0.043 (0.1180)
-1.00D	0.101 (0.1141)	0.100 (0.1099)
-1.50D	0.072 (0.1175)	0.065 (0.1302)

Population analysed: This analysis population includes all eyes successfully implanted with the test article that had at least 1 postoperative visit, no previous surgery for correction of refractive errors, no preoperative ocular pathology or macular degeneration at any time, no pregnancy during the study, and no major protocol deviations (Best-Case Analysis Set).

Adverse events

Time frame: Test article implantation through study completion, an average of 1 year.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TFNT00 - 1st Eye	3 of 149 (2%)	21 of 149 (14.1%)	0 of 149
TFNT00 - 2nd Eye	4 of 148 (2.7%)	21 of 148 (14.2%)	0 of 148
TFNT00 - Non-Study Eye	0 of 1 (0%)	0 of 1 (0%)	0 of 1
TFNT00 - Systemic	11 of 149 (7.4%)	0 of 149 (0%)	3 of 149

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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
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RecruitingObservational study
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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 Manager, Cataract study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL in people with Cataract, run by Alcon Research.

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 4 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 2 Jul 2018. 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?

Yes. Results are posted in the registry (first posted 6 Apr 2018). 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?

Mean Binocular Defocus Visual Acuity (VA) (time frame: Day 20-40 and Day 120-180 from second eye implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02529488.

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 2 Jul 2018.