Clinical Investigation of the AcrySof® IQ PanOptix™ IOL

A study testing AcrySof® IQ PanOptix™ IOL in people with Cataract, run by Alcon Research at 2 sites in Japan.

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 evaluate the effectiveness and safety of the AcrySof® IQ PanOptix™ Intraocular Lens (IOL) Model TFNT00 when implanted 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: Cataract
What is being tested?: AcrySof® IQ PanOptix™ IOL
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 2 sitesJapan
Study dates: 11 Apr 2017to 13 Feb 2018
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

Able to comprehend and sign a statement of informed consent;
Willing and able to complete all required postoperative visits;
Cataracts in both eyes with planned cataract removal by phacoemulsification;
Calculated lens power within the available range;
Potential postoperative best corrected distance visual acuity (BCDVA) of 0.5 decimal or better in both eyes;
Able to undergo second eye surgery within 30 days of the first eye surgery.

Who cannot join

Significant irregular corneal aberration as demonstrated by corneal topography;
Inflammation or edema (swelling) of the cornea affecting post-operative visual acuity;
Degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses;
Previous refractive surgery;
Diabetic retinopathy
Other eye conditions as specified in the protocol
Pregnant.

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

Alcon Investigative Site
Fukuoka, 812-0011
Alcon Investigative Site
Tokyo, 101-0061

Other trials in Japan

About this study

Official title: Clinical Investigation of the AcrySof® IQ PanOptix™ IOL Model TFNT00

Read the detailed description

Eligible subjects will attend a total of 10 visits over a 7-month period. Subjects will complete a preoperative examination of both eyes (Visit 0), followed by implantation of the IOL at the operative visit for each eye (Visit 00/00A), and up to 7 postoperative visits (each eye examined at Day 1-2 (Visit 1/1A), Day 7-14 (Visit 2/2A), and Day 30-60 (Visit 3/3A), with a binocular visit at Day 120-180 (Visit 4A) after the second implantation. The second implantation will occur within 30 days of the first.

Conditions: Cataract
Being tested: AcrySof® IQ PanOptix™ IOL
Keywords: Trifocal 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™ IOLDevice
Also called Model TFNT00
Multifocal intraocular lens (IOL) (near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient

Study groups in NCT03090256
Study group	Role	What they receive
PanOptix IOL	Experimental	AcrySof® IQ PanOptix™ IOL, bilateral implantation Receives: Device: AcrySof® IQ PanOptix™ IOL

What is being measured

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

Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Visual acuity (VA) was tested monocularly (each eye separately) under well-lit conditions with the subject's best spectacle correction at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.
Measured: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 60 cm is the VA at 60 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.
Measured: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation
Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)
VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.
Measured: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation

Timeline

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

11 Apr 201713 Feb 2018

First posted24 Mar 2017
Study start11 Apr 2017
Primary completion13 Feb 2018
Study completion13 Feb 2018

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: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03090256
Sponsor's protocol ID: ILH297-C003
Status last verified: Aug 2019
First submitted: 20 Mar 2017
Last updated: 24 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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?

See locations

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Investigation of the AcrySof® IQ PanOptix™ IOL Model TFNT00
ClinicalTrials.gov ID: NCT03090256
Acronym / sponsor ID: ILH297-C003
Conditions: Cataract
Keywords: Trifocal IOL
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 11 Apr 2017 (actual)
Primary completion: 13 Feb 2018 (actual)
Study completion: 13 Feb 2018 (actual)
First posted: 24 Mar 2017 (actual)
Results: Posted 24 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

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

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

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Able to comprehend and sign a statement of informed consent;
Willing and able to complete all required postoperative visits;
Cataracts in both eyes with planned cataract removal by phacoemulsification;
Calculated lens power within the available range;
Potential postoperative best corrected distance visual acuity (BCDVA) of 0.5 decimal or better in both eyes;

Key exclusion criteria (7 listed)

Significant irregular corneal aberration as demonstrated by corneal topography;
Inflammation or edema (swelling) of the cornea affecting post-operative visual acuity;
Degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses;
Previous refractive surgery;
Diabetic retinopathy

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

Primary outcome

Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Time frame: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation
Visual acuity (VA) was tested monocularly (each eye separately) under well-lit conditions with the subject's best spectacle correction at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
Time frame: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation
VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 60 cm is the VA at 60 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.
Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)
Time frame: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation
VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.

Results and safety

Results posted to the registry on 24 Sep 2019, 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	68	68

Primary outcome: Monocular Photopic Best Corrected Distance Visual Acuity (5 m)

Time frame: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation. Number. Unit: subjects

Measure	First Eye n = 68	Second Eye n = 67
Visit 0 preoperative: < 0.5	15	5
Visit 0 preoperative: 0.5 - < 0.7	9	8
Visit 0 preoperative: 0.7 - < 1.0	35	34
Visit 0 preoperative: 1.0 or better	9	20
Visit 1/1A: < 0.5	0	0
Visit 1/1A: 0.5 - < 0.7	1	0
Visit 1/1A: 0.7 - < 1.0	8	8
Visit 1/1A: 1.0 or better	59	59

Population analysed: All-Implanted Analysis Set

Primary outcome: Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)

Time frame: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation. Number. Unit: subjects

Measure	First Eye n = 68	Second Eye n = 67
Visit 0 preoperative: < 0.5	47	40
Visit 0 preoperative: 0.5 - < 0.7	18	18
Visit 0 preoperative: 0.7 - < 1.0	1	8
Visit 0 preoperative: 1.0 or better	2	1
Visit 1/1A: < 0.5	2	1
Visit 1/1A: 0.5 - < 0.7	8	5
Visit 1/1A: 0.7 - < 1.0	21	25
Visit 1/1A: 1.0 or better	37	36

Population analysed: All-Implanted Analysis Set

Primary outcome: Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)

Time frame: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation. Number. Unit: subjects

Measure	First Eye n = 68	Second Eye n = 67
Visit 0 preoperative: < 0.4	48	40
Visit 0 preoperative: 0.4 or better	20	27
Visit 1/1A: < 0.4	1	0
Visit 1/1A: 0.4 or better	67	67
Visit 2/2A: < 0.4	0	0
Visit 2/2A: 0.4 or better	68	67
Visit 3/3A: < 0.4	0	0
Visit 3/3A: 0.4 or better	68	67

Population analysed: All-Implanted Analysis Set

Adverse events

Time frame: IOL implantation through study completion, an average of 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TFNT00	0 of 68 (0%)	0 of 68 (0%)	0 of 68

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
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.

Group Manager, Clinical Development study director

Alcon Japan, Ltd.

2 sites 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™ IOL in people with Cataract, run by Alcon Research at 2 sites 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 6 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 24 Sep 2019. 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 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 24 Sep 2019). 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?

Monocular Photopic Best Corrected Distance Visual Acuity (5 m) (time frame: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation). 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?

On the ClinicalTrials.gov record for NCT03090256.

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 Sep 2019.