CataractNCT05481125

Clareon Toric vs Eyhance Toric

A study testing Clareon IOL, Clareon Toric IOL and Eyhance IOL in people with Cataract and Aphakia, run by Alcon Research at 8 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

The primary purpose of this study is to compare the Clareon/Clareon Toric Intraocular Lenses (IOLs) to the Eyhance/Eyhance Toric IOLs in binocular Best Corrected Distance Visual Acuity (BCDVA) at 3 months postoperative. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Cataract, Aphakia
What is being tested?: Clareon IOL, Clareon Toric IOL and Eyhance IOL
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 203 participants
Where: 8 sitesUnited States
Study dates: 10 Oct 2022to 16 Oct 2023
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 bilateral cataract removal by routine small incision phacoemulsification surgery;
Planned implantation of either test or comparator IOL (per randomization) in at least one eye with approximately 1.00 - 3.00 diopter (D) of preoperative corneal astigmatism;
Predicted postoperative astigmatism of ≤ 0.5 D in both operative eyes based on a Toric calculator;
Other protocol-specified inclusion criteria may apply.

Who cannot join

Any disease or pathology, other than cataract, that (in the investigator's opinion) may reduce potential Best Corrected Distance Visual Acuity (BCDVA) to a level worse than 0.2 logarithm minimum angle of resolution (logMAR);
Clinically significant (in the investigator's opinion) corneal pathology, dry-eye or ocular surface disease that would adversely affect a) the biometry measures and/or toric calculations and b) the visual outcome;
History of previous intraocular or corneal surgery (including laser-assisted in situ keratomileusis (LASIK));
Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI), astigmatic keratotomy, LASIK, and retinal laser treatment within the study time frame;
Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Cleveland Eye Clinic
Brecksville, Ohio, 44141
Houston Eye Associates
Houston, Texas, 77008
Berkeley Eye Center
Houston, Texas, 77027
Texas Eye Research Center
Hurst, Texas, 76054
Carolina Eyecare Physicians, LLC
Mt. Pleasant, South Carolina, 29464
Vision for Life
Nashville, Tennessee, 37205
Seeta Eye Centers
Poughkeepsie, New York, 12603
The Eye Institute of Utah
Salt Lake City, Utah, 84107

Other trials in United States

About this study

Read the detailed description

This study will enroll adults 22 years of age and older diagnosed with cataracts in both eyes with planned bilateral cataract removal by routine small incision phacoemulsification surgery. Subjects will attend up to 7 scheduled visits: A screening visit, two operative visits, and four post-operative visits. The expected individual duration of participation in the study is 3 months.

Conditions: Cataract, Aphakia
Being tested: Clareon IOL, Clareon Toric IOL, Eyhance IOL, Eyhance Toric IOL, Phacoemulsification surgery
Keywords: Cataracts, Phacoemulsification, IOL
Medical subject headings: Cataract, Aphakia

What participants receive

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

Clareon IOLDevice
Also called Model SY60WF
Alcon Clareon Aspheric Hydrophobic Acrylic IOL for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. The lens is indicated for primary implantation in the capsular bag in the posterior chamber of the eye, replacing the natural crystalline lens. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.
Clareon Toric IOLDevice
Also called Models CNW0T3, CNW0T4, CNW0T5, CNW0T6 as available
Clareon Toric Aspheric Hydrophobic Acrylic Toric IOL for the visual correction of aphakia with pre-existing corneal astigmatism in adult patients in whom a cataractous lens has been removed. The lens is indicated for primary implantation in the capsular bag in the posterior chamber of the eye, replacing the natural crystalline lens. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.
Eyhance IOLDevice
Also called Model DIB00
TECNIS Eyhance IOL with TECNIS Simplicity Delivery System for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.
Eyhance Toric IOLDevice
Also called Models DIU150, DIU225, DIU300, DIU375 as available
TECNIS Eyhance Toric II IOL with TECNIS Simplicity Delivery System for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire reduction in residual refractive cylinder. The lens is intended to be placed in the capsular bag. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.
Phacoemulsification surgeryProcedure or surgery
Cataract removal by routine small incision phacoemulsification surgery

Study groups in NCT05481125
Study group	Role	What they receive
Clareon/Clareon Toric	Experimental	Phacoemulsification surgery, followed by implantation with Alcon Clareon Aspheric Hydrophobic Acrylic IOL or Alcon Clareon Aspheric Hydrophobic Acrylic Toric IOL, as indicated. The second eye surgery is recommended to occur within 14 days after the 1st eye surgery. Receives: Device: Clareon IOL; Device: Clareon Toric IOL; Procedure: Phacoemulsification surgery
Eyhance/Eyhance Toric	Active comparator	Phacoemulsification surgery, followed by implantation with TECNIS Eyhance IOL or TECNIS Eyhance Toric II IOL, as indicated. The second eye surgery is recommended to occur within 14 days after the 1st eye surgery. Receives: Device: Eyhance IOL; Device: Eyhance Toric IOL; Procedure: Phacoemulsification surgery

What is being measured

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

Mean Binocular Best-corrected Distance Visual Acuity (BCDVA) at 4 Meters Under Bright Lighting Conditions
Visual acuity was tested at a distance of 4 meters using a refraction chart and the correction obtained from a manifest refraction. BCDVA was measured in logarithm minimum angle of resolution (logMAR) units, with 0.00 logMar equating to 20/20 Snellen, which is considered normal distance eyesight. A lower logMAR value (more negative value) indicates better eyesight. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Month 3 postoperative visit

Timeline

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

10 Oct 202216 Oct 2023

First posted1 Aug 2022
Study start10 Oct 2022
Primary completion16 Oct 2023
Study completion16 Oct 2023

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.
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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 203 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05481125
Sponsor's protocol ID: ILS241-P002
Status last verified: Oct 2024
First submitted: 28 Jul 2022
Last updated: 30 Oct 2024
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

RecruitingObservational study
Capella Scientia Development Study
Cataract
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders

All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clareon Toric vs Eyhance Toric
ClinicalTrials.gov ID: NCT05481125
Acronym / sponsor ID: ILS241-P002
Conditions: Cataract, Aphakia
Keywords: Cataracts, Phacoemulsification, IOL
Study type: Interventional
Recruitment status: Completed
Enrolment: 203 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 10 Oct 2022 (actual)
Primary completion: 16 Oct 2023 (actual)
Study completion: 16 Oct 2023 (actual)
First posted: 1 Aug 2022 (actual)
Results: Posted 30 Oct 2024

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: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Clareon/Clareon Toric	Experimental	Device: Clareon IOL, Device: Clareon Toric IOL, Procedure: Phacoemulsification surgeryPhacoemulsification surgery, followed by implantation with Alcon Clareon Aspheric Hydrophobic Acrylic IOL or Alcon Clareon Aspheric Hydrophobic Acrylic Toric IOL, as indicated. The second eye surgery is recommended to occur within 14 days after the 1st eye surgery.
Eyhance/Eyhance Toric	Active comparator	Device: Eyhance IOL, Device: Eyhance Toric IOL, Procedure: Phacoemulsification surgeryPhacoemulsification surgery, followed by implantation with TECNIS Eyhance IOL or TECNIS Eyhance Toric II IOL, as indicated. The second eye surgery is recommended to occur within 14 days after the 1st eye 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 bilateral cataract removal by routine small incision phacoemulsification surgery;
Planned implantation of either test or comparator IOL (per randomization) in at least one eye with approximately 1.00 - 3.00 diopter (D) of preoperative corneal astigmatism;
Predicted postoperative astigmatism of ≤ 0.5 D in both operative eyes based on a Toric calculator;
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (5 listed)

Any disease or pathology, other than cataract, that (in the investigator's opinion) may reduce potential Best Corrected Distance Visual Acuity (BCDVA) to a level worse than 0.2 logarithm minimum angle of resolution (logMAR);
Clinically significant (in the investigator's opinion) corneal pathology, dry-eye or ocular surface disease that would adversely affect a) the biometry measures and/or toric calculations and b) the visual outcome;
History of previous intraocular or corneal surgery (including laser-assisted in situ keratomileusis (LASIK));
Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI), astigmatic keratotomy, LASIK, and retinal laser treatment within the study time frame;
Other protocol-specified 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
Clareon IOLAlso: Model SY60WFAlcon Clareon Aspheric Hydrophobic Acrylic IOL for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. The lens is indicated for primary implantation in the capsular bag in the posterior chamber of the eye, replacing the natural crystalline lens. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.	Device	Clareon/Clareon Toric
Clareon Toric IOLAlso: Models CNW0T3, CNW0T4, CNW0T5, CNW0T6 as availableClareon Toric Aspheric Hydrophobic Acrylic Toric IOL for the visual correction of aphakia with pre-existing corneal astigmatism in adult patients in whom a cataractous lens has been removed. The lens is indicated for primary implantation in the capsular bag in the posterior chamber of the eye, replacing the natural crystalline lens. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.	Device	Clareon/Clareon Toric
Eyhance IOLAlso: Model DIB00TECNIS Eyhance IOL with TECNIS Simplicity Delivery System for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.	Device	Eyhance/Eyhance Toric
Eyhance Toric IOLAlso: Models DIU150, DIU225, DIU300, DIU375 as availableTECNIS Eyhance Toric II IOL with TECNIS Simplicity Delivery System for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire reduction in residual refractive cylinder. The lens is intended to be placed in the capsular bag. IOLs are implantable medical devices and are intended for long-term use over the lifetime of the pseudophakic subject.	Device	Eyhance/Eyhance Toric
Phacoemulsification surgeryCataract removal by routine small incision phacoemulsification surgery	Procedure or surgery	Clareon/Clareon Toric, Eyhance/Eyhance Toric

Primary outcome

Mean Binocular Best-corrected Distance Visual Acuity (BCDVA) at 4 Meters Under Bright Lighting Conditions
Time frame: Month 3 postoperative visit
Visual acuity was tested at a distance of 4 meters using a refraction chart and the correction obtained from a manifest refraction. BCDVA was measured in logarithm minimum angle of resolution (logMAR) units, with 0.00 logMar equating to 20/20 Snellen, which is considered normal distance eyesight. A lower logMAR value (more negative value) indicates better eyesight. This was a subject based assessment, and subject assigned a single score for both eyes.

Results and safety

Results posted to the registry on 30 Oct 2024, 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/Clareon Toric	89	88
Eyhance/Eyhance Toric	86	84

Primary outcome: Mean Binocular Best-corrected Distance Visual Acuity (BCDVA) at 4 Meters Under Bright Lighting Conditions

Time frame: Month 3 postoperative visit. Mean (Standard Deviation). Unit: logMAR

Measure	Clareon/Clareon Toric n = 86	Eyhance/Eyhance Toric n = 81
Value	-0.100 (0.0880)	-0.055 (0.0716)

Clareon/Clareon Toric vs Eyhance/Eyhance Toric: Mean Difference (Final Values): -0.045

Population analysed: AAS with data at visit

Adverse events

Time frame: Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 3 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pretreatment	0 of 175 (0%)	0 of 175 (0%)	0 of 175
Clareon/Clareon Toric First Eye	2 of 89 (2.2%)	11 of 89 (12.4%)	0 of 89
Clareon/Clareon Toric Second Eye	0 of 86 (0%)	8 of 86 (9.3%)	0 of 86
Clareon/Clareon Toric Systemic	2 of 89 (2.2%)	0 of 89 (0%)	0 of 89
Eyhance/Eyhance Toric First Eye	2 of 86 (2.3%)	6 of 86 (7%)	0 of 86
Eyhance/Eyhance Toric Second Eye	0 of 84 (0%)	7 of 84 (8.3%)	0 of 84
Eyhance/Eyhance Toric Systemic	3 of 86 (3.5%)	0 of 86 (0%)	0 of 86

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Cataract

RecruitingObservational study
Capella Scientia Development Study
Cataract
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
RecruitingObservational study
Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
Cataract, Primary Angle-Closure Glaucoma
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders

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 Trial Lead, CDMA Surgical study director

Alcon Research, LLC

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

Questions about this trial

What is this clinical trial studying?

A study testing Clareon IOL, Clareon Toric IOL and Eyhance IOL in people with Cataract and Aphakia, run by Alcon Research at 8 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 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 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 30 Oct 2024). 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 Best-corrected Distance Visual Acuity (BCDVA) at 4 Meters Under Bright Lighting Conditions (time frame: Month 3 postoperative visit). 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 NCT05481125.

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 30 Oct 2024.