CataractNCT03170154

Clinical Investigation of the Clareon® Intraocular Lens (IOL)

A study testing Clareon aspheric hydrophobic acrylic monofocal IOL in people with Cataract, run by Alcon Research at 16 sites in United States.

Completed

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

Official record

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Trial summary

The objective of this study is to compare visual acuity and adverse event outcomes from the Clareon intraocular lens (IOL) to historical safety and performance endpoint (SPE) rates. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Cataract
What is being tested?: Clareon aspheric hydrophobic acrylic monofocal IOL
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 376 participants
Where: 16 sitesUnited States
Study dates: 25 Jul 2017to 15 Feb 2019
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

Planned routine cataract surgery in at least one eye;
Calculated lens power within the available range;
Willing and able to sign an informed consent statement;
Clear intraocular media other than cataract.

Who cannot join

Any disease or pathology, other than cataract, that is expected to reduce the potential postoperative best corrected distance visual acuity (BCDVA) to a level worse than 0.30 logMAR;
Previous corneal surgery;
Rubella or traumatic cataract;
Ocular trauma, previous refractive surgery;
Current or recent use of certain medications as specified in the protocol;
Any other ocular or systemic condition that, in the opinion of the Investigator, should exclude the subject from the study.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Alcon Investigative Site
Appleton, Wisconsin, 54914
Alcon Investigative Site
Austin, Texas, 78731
Alcon Investigative Site
Bloomfield Hills, Michigan, 48302
Alcon Investigative Site
Deerfield Beach, Florida, 33064
Alcon Investigative Site
Elizabeth City, North Carolina, 27909
Alcon Investigative Site
Florence, South Carolina, 29501
Alcon Investigative Site
Fresno, California, 93720
Alcon Investigative Site
Kansas City, Missouri, 64154
Alcon Investigative Site
Ladson, South Carolina, 29456
Alcon Investigative Site
Nacogdoches, Texas, 75965
Alcon Investigative Site
New York, New York, 10013
Alcon Investigative Site
Orland Park, Illinois, 60467
Alcon Investigative Site
Poughkeepsie, New York, 12603
Alcon Investigative Site
Sacramento, California, 95815
Alcon Investigative Site
San Leandro, California, 94578
Alcon Investigative Site
Southern Pines, North Carolina, 28387

Other trials in United States

About this study

Official title: Clinical Investigation of the Clareon® IOL

The objective of this study is to compare visual acuity and adverse event outcomes from the Clareon intraocular lens (IOL) to historical safety and performance endpoint (SPE) rates.

Read the detailed description

Upon meeting eligibility criteria, subjects were implanted unilaterally (in one eye) with a Clareon IOL. Subjects attended 7 study visits over a period of approximately 13 months, including 1 preoperative screening visit (Visit 0), 1 operative visit (Visit 00), and 5 postoperative visits (Visits 1-5). Visit day calculations for Visits 1-5 were based off of the day of surgery (Visit 00). Primary endpoint data was collected at the final visit (Month 12). Some sites/subjects participated in a Rotational Stability sub-study. For the non-study eye, the investigator followed standard of care regarding the follow-up, surgery, and intraocular lens choice (as applicable). The non-study eye (fellow eye) was not implanted with the Clareon IOL.

Conditions: Cataract
Being tested: Clareon aspheric hydrophobic acrylic monofocal IOL
Medical subject headings: Cataract

What participants receive

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

Clareon aspheric hydrophobic acrylic monofocal IOLDevice
Ultraviolet-absorbing and blue light-filtering IOL composed of high refractive-index foldable and flexible acrylic material. IOLs are implantable medical devices intended for long term use over the lifetime of the cataract subject.

Study groups in NCT03170154
Study group	Role	What they receive
Clareon IOL	Experimental	Clareon aspheric hydrophobic acrylic monofocal IOL implanted in one eye during routine small incision cataract surgery Receives: Device: Clareon aspheric hydrophobic acrylic monofocal IOL

What is being measured

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

Percentage of All-implanted Subjects Achieving Monocular Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better at Month 12 Postoperative
Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity outcomes with most subjects achieving 0.3 logMAR or better.
Measured: Month 12 (postoperative)
Percentage of Best-case Subjects Achieving Monocular BCDVA of 0.3 logMAR or Better at Month 12 Postoperative
Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic conditions at a distance of 4 meters using an Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity outcomes with most subjects achieving 0.3 logMAR or better.
Measured: Month 12 (postoperative)
Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye
Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. No hypothesis testing was pre-specified in the protocol.
Measured: Day 0 (operative), up to Month 12 (postoperative)

Secondary outcomes (3)

Mean Absolute IOL Rotation
IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and Month 6. IOL rotation and measured with slit-lamp photography. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL rotation at 6 months.
Measured: Day 0 (operative), Month 6 (postoperative)
Mean Absolute IOL Misplacement
IOL misplacement was defined as the difference between intended axis of placement and actual axis of IOL orientation on day of surgery. IOL misplacement was measured using slit lamp photography. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL misplacement.
Measured: Day 0 (operative)
Mean Absolute IOL Misalignment
IOL misalignment was defined as the summation of IOL misplacement and IOL rotation at Month 6. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL misalignment at 6 months.
Measured: Day 0 (operative), Month 6 (postoperative)

Timeline

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

25 Jul 201715 Feb 2019

First posted30 May 2017
Study start25 Jul 2017
Primary completion15 Feb 2019
Study completion15 Feb 2019

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: 376 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03170154
Sponsor's protocol ID: ILJ466-C001
Status last verified: Jul 2020
First submitted: 26 May 2017
Last updated: 3 Aug 2020
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 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Investigation of the Clareon® IOL
ClinicalTrials.gov ID: NCT03170154
Acronym / sponsor ID: ILJ466-C001
Conditions: Cataract
Study type: Interventional
Recruitment status: Completed
Enrolment: 376 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 25 Jul 2017 (actual)
Primary completion: 15 Feb 2019 (actual)
Study completion: 15 Feb 2019 (actual)
First posted: 30 May 2017 (actual)
Results: Posted 9 Mar 2020

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 compare visual acuity and adverse event outcomes from the Clareon intraocular lens (IOL) to historical safety and performance endpoint (SPE) rates.

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
Clareon IOL	Experimental	Device: Clareon aspheric hydrophobic acrylic monofocal IOLClareon aspheric hydrophobic acrylic monofocal IOL implanted in one eye during routine small incision cataract surgery

Who may qualify

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

Key inclusion criteria (4 listed)

Planned routine cataract surgery in at least one eye;
Calculated lens power within the available range;
Willing and able to sign an informed consent statement;
Clear intraocular media other than cataract.

Key exclusion criteria (6 listed)

Any disease or pathology, other than cataract, that is expected to reduce the potential postoperative best corrected distance visual acuity (BCDVA) to a level worse than 0.30 logMAR;
Previous corneal surgery;
Rubella or traumatic cataract;
Ocular trauma, previous refractive surgery;
Current or recent use of certain medications as specified in the protocol;

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
Clareon aspheric hydrophobic acrylic monofocal IOLUltraviolet-absorbing and blue light-filtering IOL composed of high refractive-index foldable and flexible acrylic material. IOLs are implantable medical devices intended for long term use over the lifetime of the cataract subject.	Device	Clareon IOL

Primary outcome

Percentage of All-implanted Subjects Achieving Monocular Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better at Month 12 Postoperative
Time frame: Month 12 (postoperative)
Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity outcomes with most subjects achieving 0.3 logMAR or better.
Percentage of Best-case Subjects Achieving Monocular BCDVA of 0.3 logMAR or Better at Month 12 Postoperative
Time frame: Month 12 (postoperative)
Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic conditions at a distance of 4 meters using an Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity outcomes with most subjects achieving 0.3 logMAR or better.
Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye
Time frame: Day 0 (operative), up to Month 12 (postoperative)
Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. No hypothesis testing was pre-specified in the protocol.

3 secondary outcomes

Mean Absolute IOL Rotation
Time frame: Day 0 (operative), Month 6 (postoperative)
Mean Absolute IOL Misplacement
Time frame: Day 0 (operative)
Mean Absolute IOL Misalignment
Time frame: Day 0 (operative), Month 6 (postoperative)

Results and safety

Results posted to the registry on 9 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Clareon IOL	350	342

Primary outcome: Percentage of All-implanted Subjects Achieving Monocular Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better at Month 12 Postoperative

Time frame: Month 12 (postoperative). Number (95% Confidence Interval). Unit: percentage of subjects

Measure	Clareon IOL n = 342
Value	99.7 (98.38 to 99.99)

Clareon IOL: 1-sided 95% Upper CL: 99.99

Population analysed: All-Implanted Subjects (AAS): All subjects/eyes with successful IOL implantation and data at visit

Primary outcome: Percentage of Best-case Subjects Achieving Monocular BCDVA of 0.3 logMAR or Better at Month 12 Postoperative

Time frame: Month 12 (postoperative). Number (95% Confidence Interval). Unit: percentage of subjects

Measure	Clareon IOL n = 326
Value	99.7 (98.30 to 99.99)

Clareon IOL: 1-sided 95% Upper CL: 99.98

Population analysed: Best-Case Analysis Set (BAS): All subjects/eyes successfully implanted with the IOL that had at least 1 postoperative visit, no preoperative ocular pathology, no macular degeneration at any time, and no previous surgery for the correction of refractive errors, with data at visit.

Primary outcome: Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye

Time frame: Day 0 (operative), up to Month 12 (postoperative). Number. Unit: percentage of subjects

Measure	Pre-treatment n = 350	Clareon IOL - Ocular n = 350	Systemic n = 350
Serious Adverse Events	0	2.3	4.0
Non-Serious Adverse Events	1.4	27.1	15.1

Population analysed: Safety Analysis Set (SAS): All subjects/study eyes with attempted implantation with the test article (successful or aborted after contact with the eye)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected pre-treatment (Day -30 to 0) up to Month 12 post-treatment/study exit. Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-treatment	0 of 350 (0%)	6 of 350 (1.7%)	0 of 350
Clareon IOL - Ocular (Study Eye)	8 of 350 (2.3%)	19 of 350 (5.4%)	0 of 350
Systemic and Ocular Non-Study (Non-Clareon) Eye	18 of 350 (5.1%)	127 of 350 (36.3%)	2 of 350

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
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 Research, LLC

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Clareon aspheric hydrophobic acrylic monofocal IOL in people with Cataract, run by Alcon Research at 16 sites in United States.

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 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. 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 9 Mar 2020). 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 All-implanted Subjects Achieving Monocular Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better at Month 12 Postoperative (time frame: Month 12 (postoperative)). 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 NCT03170154.

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 3 Aug 2020.