AphakiaNCT07502456
Clareon TruPlus Study
A study testing Clareon TruPlus Monofocal Non-Toric IOL, Clareon TruPlus Monofocal Toric IOL and Phacoemulsification in people with Aphakia and Astigmatism, run by Alcon Research at 5 sites in United States.
Trial summary
The purpose of this research study is to generate safety and performance data for Clareon TruPlus Monofocal Intraocular Lenses (IOLs). IOLs are medical devices that are implanted in the eye during cataract surgery to restore clear vision after the cloudy natural lens has been removed. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Aphakia, Astigmatism
- What is being tested?
- Clareon TruPlus Monofocal Non-Toric IOL, Clareon TruPlus Monofocal Toric IOL and Phacoemulsification
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 5 sitesUnited States
- Study dates
- 26 May 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosed with bilateral cataracts and planned bilateral cataract extraction by routine phacoemulsification.
- Potential postoperative BCDVA of 0.2 logMAR or better in each eye in the expert medical opinion of the investigator.
- Astigmatism suitable for correction with available toric IOL models.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Age-related macular degeneration (AMD), glaucoma, diabetic retinopathy, and other eye conditions as specified in the protocol.
- Moderate to severe dry eye that would affect study measurements.
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Cleveland Eye Clinic
Brecksville, Ohio, 44141
- Recruiting
Carolina Eyecare Physicians LLC
Mt. Pleasant, South Carolina, 29464
- Recruiting
Eye Doctors of Arizona
Phoenix, Arizona, 85028
- Recruiting
The Eye Institute of Utah
Salt Lake City, Utah, 84107
- Recruiting
Berkeley Eye Center
Sugar Land, Texas, 77478
About this study
Official title: Clareon TruPlus Single-Arm Study
The purpose of this research study is to generate safety and performance data for Clareon TruPlus Monofocal Intraocular Lenses (IOLs). IOLs are medical devices that are implanted in the eye during cataract surgery to restore clear vision after the cloudy natural lens has been removed. IOLs are intended to remain in the eyes for the duration of the patient's lifetime.
Read the detailed description
In this study, subjects will be implanted with Clareon TruPlus Monofocal IOLs. The IOL to be implanted (Non-Toric or Toric) will be based on the recommendation of an IOL calculator.
Subjects will attend 8 study visits, including one preoperative visit, two surgical visits, and five postoperative visits. The second eye surgery will occur 0-14 days after the first eye surgery. The total duration of a subject's participation in the study will be approximately 13 months.
- Conditions
- Aphakia, Astigmatism
- Being tested
- Clareon TruPlus Monofocal Non-Toric IOL, Clareon TruPlus Monofocal Toric IOL, Phacoemulsification
- Keywords
- Cataract
- 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.
Clareon TruPlus Monofocal Non-Toric IOLDevice
Also called Models REYWT0, REYAT0, RECWT0, RECAT0
Monofocal IOL implanted in the capsular bag in the eye for the visual correction of aphakia in adult patients. The Clareon TruPlus IOL is designed to maintain distance image quality while slightly extending the depth of focus compared to standard monofocal IOLs.
Clareon TruPlus Monofocal Toric IOLDevice
Also called Models REYWT3, REYWT4, REYWT5, REYAT3, REYAT4, REYAT5, RECWT3, RECWT4, RECWT5, RECAT3, RECAT4, RECAT5.
Monofocal IOL implanted in the capsular bag in the eye for the visual correction of aphakia and pre-existing corneal astigmatism. The Clareon TruPlus IOL is designed to maintain distance image quality while slightly extending the depth of focus compared to standard monofocal IOLs.
PhacoemulsificationProcedure or surgery
Minimally invasive surgery technique that utilizes ultrasonic vibrations to break up (emulsify) and remove a cloudy lens through a small, self-sealing, 2-3mm incision
| Study group | Role | What they receive |
|---|---|---|
| Clareon TruPlus Monofocal IOL | Experimental | Implantation with the Clareon TruPlus Monofocal IOL (Non-Toric or Toric) following removal of the clouded natural lens using phacoemulsification Receives: Device: Clareon TruPlus Monofocal Non-Toric IOL; Device: Clareon TruPlus Monofocal Toric IOL; Procedure: Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
Visual acuity (VA) will be assessed binocularly (both eyes together) with correction in place under photopic (well-lit) conditions at a distance of 4 meters. BCDVA will be measured using letter charts and recorded in logarithm of the Minimum Angle of Resolution (logMAR). The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. Subjects with at least one implanted eye with a toric IOL will be categorized as toric as specified in the statistical analysis plan. No hypothesis testing is pre-specified for this endpoint
Measured: Day 0 preoperative, Month 1, Month 3, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start26 May 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphakiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Surgical, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502456
- Sponsor's protocol ID
- ILM335-P001
- Status last verified
- Jun 2026
- First submitted
- 26 Mar 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clareon TruPlus Single-Arm Study
- ClinicalTrials.gov ID
- NCT07502456
- Acronym / sponsor ID
- ILM335-P001
- Conditions
- Aphakia, Astigmatism
- Keywords
- Cataract
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 26 May 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
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 research study is to generate safety and performance data for Clareon TruPlus Monofocal Intraocular Lenses (IOLs). IOLs are medical devices that are implanted in the eye during cataract surgery to restore clear vision after the cloudy natural lens has been removed. IOLs are intended to remain in the eyes for the duration of the patient's lifetime.
Detailed description
In this study, subjects will be implanted with Clareon TruPlus Monofocal IOLs. The IOL to be implanted (Non-Toric or Toric) will be based on the recommendation of an IOL calculator.
Subjects will attend 8 study visits, including one preoperative visit, two surgical visits, and five postoperative visits. The second eye surgery will occur 0-14 days after the first eye surgery. The total duration of a subject's participation in the study will be approximately 13 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clareon TruPlus Monofocal IOL | Experimental | Device: Clareon TruPlus Monofocal Non-Toric IOL, Device: Clareon TruPlus Monofocal Toric IOL, Procedure: PhacoemulsificationImplantation with the Clareon TruPlus Monofocal IOL (Non-Toric or Toric) following removal of the clouded natural lens using phacoemulsification |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with bilateral cataracts and planned bilateral cataract extraction by routine phacoemulsification.
- Potential postoperative BCDVA of 0.2 logMAR or better in each eye in the expert medical opinion of the investigator.
- Astigmatism suitable for correction with available toric IOL models.
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (3 listed)
- Age-related macular degeneration (AMD), glaucoma, diabetic retinopathy, and other eye conditions as specified in the protocol.
- Moderate to severe dry eye that would affect study measurements.
- 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 TruPlus Monofocal Non-Toric IOLAlso: Models REYWT0, REYAT0, RECWT0, RECAT0Monofocal IOL implanted in the capsular bag in the eye for the visual correction of aphakia in adult patients. The Clareon TruPlus IOL is designed to maintain distance image quality while slightly extending the depth of focus compared to standard monofocal IOLs. | Device | Clareon TruPlus Monofocal IOL |
| Clareon TruPlus Monofocal Toric IOLAlso: Models REYWT3, REYWT4, REYWT5, REYAT3, REYAT4, REYAT5, RECWT3, RECWT4, RECWT5, RECAT3, RECAT4, RECAT5.Monofocal IOL implanted in the capsular bag in the eye for the visual correction of aphakia and pre-existing corneal astigmatism. The Clareon TruPlus IOL is designed to maintain distance image quality while slightly extending the depth of focus compared to standard monofocal IOLs. | Device | Clareon TruPlus Monofocal IOL |
| PhacoemulsificationMinimally invasive surgery technique that utilizes ultrasonic vibrations to break up (emulsify) and remove a cloudy lens through a small, self-sealing, 2-3mm incision | Procedure or surgery | Clareon TruPlus Monofocal IOL |
Primary outcome
Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
Time frame: Day 0 preoperative, Month 1, Month 3, Month 12
Visual acuity (VA) will be assessed binocularly (both eyes together) with correction in place under photopic (well-lit) conditions at a distance of 4 meters. BCDVA will be measured using letter charts and recorded in logarithm of the Minimum Angle of Resolution (logMAR). The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. Subjects with at least one implanted eye with a toric IOL will be categorized as toric as specified in the statistical analysis plan. No hypothesis testing is pre-specified for this endpoint
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- 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.
Clinical Trial Lead, Surgical study director
Alcon Research, LLC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clareon TruPlus Monofocal Non-Toric IOL, Clareon TruPlus Monofocal Toric IOL and Phacoemulsification in people with Aphakia and Astigmatism, run by Alcon Research at 5 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 3 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alcon Call Center (1-888-451-3937, alcon.medinfo@alcon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) (time frame: Day 0 preoperative, Month 1, Month 3, Month 12). 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 3 Jun 2026.