Age Related CataractsNCT07006428
Visual Performance of Clareon PanOptix vs. a Comparable Multifocal Intraocular Lens
A study testing Clareon PanOptix or PanOptix Toric IOLs and Comparable multifocal IOL in people with Age Related Cataracts, run by Argus Research Center, Inc. at 3 sites in United States.
Trial summary
This is a two-part, multi-center, investigator-initiated clinical study comparing visual outcomes and patient satisfaction in subjects receiving bilateral implantation of either the Clareon PanOptix intraocular lens (IOL) or a comparable multifocal IOL. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Age Related Cataracts
- What is being tested?
- Clareon PanOptix or PanOptix Toric IOLs and Comparable multifocal IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 May 2025to Nov 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stage 1: IIT Pilot
- Willing and able to understand and sign informed consent.
- Adult patients previously diagnosed with age-related cataracts bilaterally.
- Previous bilateral age-related cataract removal and with bilateral implantation of the Clareon PanOptix/ Clareon PanOptix Toric (T3-T4) or Comparable Multifocal Intraocular Lens (equivalent to T3-T4) closest to 2.5-5-months after implantation and >2 weeks post YAG (if done) that were targeted for emmetropia.
- Best monocular corrected distance visual acuity was expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes pre-operatively as determined by surgeon.
- Normal ocular findings aside from cataract.
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- Stage 2: Comparison
- Willing and able to understand and sign informed consent.
- Adult patient diagnosed with age-related cataracts bilaterally.
- Planned bilateral cataract removal by femtosecond laser-assisted phacoemulsification with bilateral implantation of the Clareon PanOptix/Clareon PanOptix Toric (T3-T4) or Comparable Multifocal Intraocular Lens (equivalent to T3-T4).
- Best monocular corrected distance visual acuity expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes postoperatively as determined by surgeon.
- Residual astigmatism expected to be ≤ 0.50 diopters in both eyes postoperatively as determined by surgeon (after using either toric IOL or arcuate incision with laser).
- Normal ocular findings aside from cataract.
Who cannot join
- Stage 1: IIT Pilot
- Corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases, diabetic retinopathy that is expected to cause future vision loss, glaucoma, severe dry eye disease, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation.
- Previous history of any ocular surgery including corneal refractive surgery.
- Participation in another clinical study that could interfere with the results.
- Patients with monovision correction.
- Any active ocular infection or inflammation.
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- Stage 2: Comparison
- Corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative
- diseases that is expected to cause future vision loss, glaucoma, severe dry eye disease, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation.
- Previous history of any ocular surgery including corneal refractive surgery.
- Participants desiring monovision.
- History of amblyopia or monofixation syndrome with poor stereoscopic vision.
- Total corneal HOA greater than 0.6um, coma less than 0.3um at 4mm-5mm scan depending on pre- op photopic topography.
- Any planned simultaneous/combined procedures at time of cataract surgery (e.g. MIGs).
- Participation in another clinical study that could interfere with the results.
- Any active ocular infection or inflammation.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Tyson Eye
Cape Coral, Florida, 33904
Angela Hartline, (239) 542-2020, angela.hartline@tysoneye.com
- Recruiting
North Georgia Eye Associates
Gainesville, Georgia, 30501
MaryAnn Thomas, 470-870-7311, matyann.thomas@ngeye.com
- Recruiting
Wolstan & Goldberg Eye Associates
Torrance, California, 90505
Cynthia Montes, (310) 543-2611, cynthia@wgeye.com
About this study
Official title: Visual Performance Differences Between Clareon PanOptix and a Comparable Multifocal Intraocular Lens
This is a two-part, multi-center, investigator-initiated clinical study comparing visual outcomes and patient satisfaction in subjects receiving bilateral implantation of either the Clareon PanOptix intraocular lens (IOL) or a comparable multifocal IOL. The study includes a retrospective/prospective pilot phase and a prospective, randomized comparison phase.
- Conditions
- Age Related Cataracts
- Being tested
- Clareon PanOptix or PanOptix Toric IOLs, Comparable multifocal IOL
- Keywords
- Clareon PanOptix, Multifocal IOL, Cataract Surgery, Visual Acuity, Intraocular Lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clareon PanOptix or PanOptix Toric IOLsDevice
Bilateral implantation of the Clareon PanOptix or PanOptix Toric IOLs.
Comparable multifocal IOLDevice
Bilateral implantation of a comparable multifocal IOL
| Study group | Role | What they receive |
|---|---|---|
| Clareon PanOptix or PanOptix Toric IOLs | Experimental | Not described Receives: Device: Clareon PanOptix or PanOptix Toric IOLs |
| Comparable multifocal IOL | Experimental | Not described Receives: Device: Comparable multifocal IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular photopic BCDVA (4m)
Measured: 2.5 to 5 months postoperatively
Binocular BCDVA (4m)
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start7 May 2025
- Primary completionOct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related CataractsStudies 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, Outcomes assessor
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Argus Research Center, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006428
- Sponsor's protocol ID
- SUPER-IIT-96028407
- Status last verified
- May 2025
- First submitted
- 28 May 2025
- Last updated
- 5 Jun 2025
- 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 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Performance Differences Between Clareon PanOptix and a Comparable Multifocal Intraocular Lens
- ClinicalTrials.gov ID
- NCT07006428
- Acronym / sponsor ID
- SUPER-IIT-96028407
- Conditions
- Age Related Cataracts
- Keywords
- Clareon PanOptix, Multifocal IOL, Cataract Surgery, Visual Acuity, Intraocular Lens
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Argus Research Center, Inc.University, hospital or other
- Study start
- 7 May 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 5 Jun 2025 (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.
This is a two-part, multi-center, investigator-initiated clinical study comparing visual outcomes and patient satisfaction in subjects receiving bilateral implantation of either the Clareon PanOptix intraocular lens (IOL) or a comparable multifocal IOL. The study includes a retrospective/prospective pilot phase and a prospective, randomized comparison phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clareon PanOptix or PanOptix Toric IOLs | Experimental | Device: Clareon PanOptix or PanOptix Toric IOLs |
| Comparable multifocal IOL | Experimental | Device: Comparable multifocal IOL |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Stage 1: IIT Pilot
- Willing and able to understand and sign informed consent.
- Adult patients previously diagnosed with age-related cataracts bilaterally.
- Previous bilateral age-related cataract removal and with bilateral implantation of the Clareon PanOptix/ Clareon PanOptix Toric (T3-T4) or Comparable Multifocal Intraocular Lens (equivalent to T3-T4) closest to 2.5-5-months after implantation and >2 weeks post YAG (if done) that were targeted for emmetropia.
- Best monocular corrected distance visual acuity was expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes pre-operatively as determined by surgeon.
Key exclusion criteria (16 listed)
- Stage 1: IIT Pilot
- Corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases, diabetic retinopathy that is expected to cause future vision loss, glaucoma, severe dry eye disease, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation.
- Previous history of any ocular surgery including corneal refractive surgery.
- Participation in another clinical study that could interfere with the results.
- Patients with monovision correction.
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 PanOptix or PanOptix Toric IOLsBilateral implantation of the Clareon PanOptix or PanOptix Toric IOLs. | Device | Clareon PanOptix or PanOptix Toric IOLs |
| Comparable multifocal IOLBilateral implantation of a comparable multifocal IOL | Device | Comparable multifocal IOL |
Primary outcome
Binocular photopic BCDVA (4m)
Time frame: 2.5 to 5 months postoperatively
Binocular BCDVA (4m)
Time frame: Month 3
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 5 Jun 2025.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clareon PanOptix or PanOptix Toric IOLs and Comparable multifocal IOL in people with Age Related Cataracts, run by Argus Research Center, Inc. at 3 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 13 inclusion and 16 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 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binocular photopic BCDVA (4m) (time frame: 2.5 to 5 months postoperatively). The study lists 2 primary outcomes in all. 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 5 Jun 2025.