CataractPhase 4NCT06922084
A Prospective, Randomized, Subject and Vision-assessor Masked, Multicenter Study Comparing Bilateral Clareon PanOptix, Bilateral Clareon PanOptix Pro, and Mixed Clareon PanOptix Pro/Vivity Intraocular Lens Implantation in Cataract Subjects
A Phase 4 study testing Clareon PanOptix, Clareon PanOptix PRO and Mix-and-Match PanOptix/Vivity in people with Cataract, run by Berkeley Eye Center at 2 sites in United States.
Trial summary
Prospective, randomized, multicenter, multi-arm, subject and vision-assessor-masked, two stage study with Stage 1 as a three-arm initial enrollment period, followed by Stage 2 as a head-to-head study refined based on the Stage 1 data. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Clareon PanOptix, Clareon PanOptix PRO and Mix-and-Match PanOptix/Vivity
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Mar 2025to Apr 2027
- Phase
- Phase 4
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult cataract patients aged 40 years and older scheduled for age related cataract surgery in both eyes.
- Ability to understand and sign an ethics committee-approved informed consent form.
- Willingness and ability to attend all scheduled study visits as required by the protocol.
- Postoperative potential visual acuity of 20/25 or better in each eye, as determined by the investigator.
- Preoperative corneal astigmatism that can be corrected with a T3 or T4 toric IOL, or with a spherical IOL and LRIs or AKs resulting in a predicted postoperative astigmatism of less than 0.5 diopters (D).
- Ability to understand and complete questionnaires.
Who cannot join
- Women who are pregnant, planning to become pregnant during the study, or breastfeeding.
- Ocular conditions that could confound study results, including moderate to severe corneal pathology, irregular astigmatism, moderate to severe dry eye, preexisting retinal diseases such as macular degeneration or diabetic retinopathy.
- Any form of confirmed glaucomatous damage (ie, mild, moderate, or severe glaucoma).
- Participation in another clinical study that could interfere with the results.
- Systemic conditions that may affect healing or visual outcomes (e.g., uncontrolled diabetes mellitus, certain autoimmune disorders).
- Subjects with nystagmus, strabismus, zonular laxity or dehiscence, and pseudoexfoliation.
Show all 11Show fewer
- Prior ocular surgery (except for uncomplicated cataract surgery in the fellow eye).
- Participants desiring monovision.
- Any active ocular infection or inflammation (except for routine post-operative inflammation in the fellow eye)
- Psychiatric or cognitive disorders that may impair the ability to comply with study procedures or provide accurate self-assessments.
- RMS total higher-order aberrations (HOAs) >0.70 µm or coma >0.40 µm as measured by tomography or topography with a 4 mm pupil setting.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Berkeley Eye Center
Houston, Texas, 77027
Tetiana Huff, 713-620-7640, tetiana.huff@berkeleyeye.com
Morgan Micheletti, MD
- Recruiting
Shafer Vision Institute
Plymouth Meeting, Pennsylvania, 19462
Ailinn Dunn, ailinn@shafervision.com
Brian Shafer
About this study
Prospective, randomized, multicenter, multi-arm, subject and vision-assessor-masked, two stage study with Stage 1 as a three-arm initial enrollment period, followed by Stage 2 as a head-to-head study refined based on the Stage 1 data.
- Conditions
- Cataract
- Being tested
- Clareon PanOptix, Clareon PanOptix PRO, Mix-and-Match PanOptix/Vivity
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clareon PanOptixDevice
Bilateral Clareon PanOptix IOL implantation
Clareon PanOptix PRODrug
Bilateral Clareon PanOptix PRO IOL implantation
Mix-and-Match PanOptix/VivityDrug
Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Clareon PanOptix IOL implantation | Active comparator | Not described Receives: Device: Clareon PanOptix |
| Bilateral Clareon PanOptix Pro IOL implantation | Experimental | Not described Receives: Drug: Clareon PanOptix PRO |
| Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye | Experimental | Not described Receives: Drug: Mix-and-Match PanOptix/Vivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular photopic CDVA (corrected distance visual acuity)
Measured: 3 months postoperatively
Secondary outcomes (11)
Binocular photopic DCIVA (distance corrected intermediate visual acuity) and DCNVA (distance corrected near visual acuity)
Measured: 3 months postoperatively
Binocular photopic uncorrected visual acuity at distance (UDVA), intermediate (UIVA), and near (UNVA)
Measured: 3 months postoperatively
Binocular photopic small letter contrast sensitivity at 66 cm and 100 cm with refractive distance correction (20/32 line)
Measured: 3 months postoperatively
Binocular mesopic high contrast distance corrected visual acuity at distance (CDVA), intermediate (DCIVA), and near (DCNVA).
Measured: 3 months postoperatively
Binocular photopic distance corrected defocus curve
Obtained by varying the vergence of the stimulus from -3.0 D to +1.0 D in steps of 0.5 D with the best correction for distance vision.
Measured: 3 months postoperatively
Monocular photopic distance corrected defocus curves
Obtained by varying the vergence of the stimulus from -3.0 D to +1.0 D in steps of 0.5 D with the best correction for distance vision.
Measured: 3 months postoperatively
Binocular mesopic distance corrected contrast sensitivity with and without glare (1.5, 3, 6 & 12 cpd)
Measured: 3 months postoperatively
Refractive outcomes
Mean residual manifest refraction spherical equivalent (MRSE) and residual astigmatism.
Measured: 3 months postoperatively
Pupil size
Under both photopic and mesopic conditions.
Measured: 3 months postoperatively
Patient-reported outcomes using a questionnaire about visual disturbances (QUVID)
Measured: 3 months postoperatively
Patient-reported outcomes using a questionnaire about IOL satisfaction (IOLSAT)
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start17 Mar 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Berkeley Eye Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Morgan Micheletti, MD, Principal investigator, Berkeley Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922084
- Sponsor's protocol ID
- 95474481
- Status last verified
- Sep 2026
- First submitted
- 28 Mar 2025
- Last updated
- 30 Sep 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Subject and Vision-assessor Masked, Multicenter Study Comparing Bilateral Clareon PanOptix, Bilateral Clareon PanOptix Pro, and Mixed Clareon PanOptix Pro/Vivity Intraocular Lens Implantation in Cataract Subjects
- ClinicalTrials.gov ID
- NCT06922084
- Acronym / sponsor ID
- 95474481
- Conditions
- Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Berkeley Eye CenterUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 10 Apr 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.
Prospective, randomized, multicenter, multi-arm, subject and vision-assessor-masked, two stage study with Stage 1 as a three-arm initial enrollment period, followed by Stage 2 as a head-to-head study refined based on the Stage 1 data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bilateral Clareon PanOptix IOL implantation | Active comparator | Device: Clareon PanOptix |
| Bilateral Clareon PanOptix Pro IOL implantation | Experimental | Drug: Clareon PanOptix PRO |
| Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye | Experimental | Drug: Mix-and-Match PanOptix/Vivity |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult cataract patients aged 40 years and older scheduled for age related cataract surgery in both eyes.
- Ability to understand and sign an ethics committee-approved informed consent form.
- Willingness and ability to attend all scheduled study visits as required by the protocol.
- Postoperative potential visual acuity of 20/25 or better in each eye, as determined by the investigator.
- Preoperative corneal astigmatism that can be corrected with a T3 or T4 toric IOL, or with a spherical IOL and LRIs or AKs resulting in a predicted postoperative astigmatism of less than 0.5 diopters (D).
Key exclusion criteria (11 listed)
- Women who are pregnant, planning to become pregnant during the study, or breastfeeding.
- Ocular conditions that could confound study results, including moderate to severe corneal pathology, irregular astigmatism, moderate to severe dry eye, preexisting retinal diseases such as macular degeneration or diabetic retinopathy.
- Any form of confirmed glaucomatous damage (ie, mild, moderate, or severe glaucoma).
- Participation in another clinical study that could interfere with the results.
- Systemic conditions that may affect healing or visual outcomes (e.g., uncontrolled diabetes mellitus, certain autoimmune disorders).
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 PanOptixBilateral Clareon PanOptix IOL implantation | Device | Bilateral Clareon PanOptix IOL implantation |
| Clareon PanOptix PROBilateral Clareon PanOptix PRO IOL implantation | Drug | Bilateral Clareon PanOptix Pro IOL implantation |
| Mix-and-Match PanOptix/VivityClareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye | Drug | Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye |
Primary outcome
Binocular photopic CDVA (corrected distance visual acuity)
Time frame: 3 months postoperatively
11 secondary outcomes
Binocular photopic DCIVA (distance corrected intermediate visual acuity) and DCNVA (distance corrected near visual acuity)
Time frame: 3 months postoperatively
Binocular photopic uncorrected visual acuity at distance (UDVA), intermediate (UIVA), and near (UNVA)
Time frame: 3 months postoperatively
Binocular photopic small letter contrast sensitivity at 66 cm and 100 cm with refractive distance correction (20/32 line)
Time frame: 3 months postoperatively
Binocular mesopic high contrast distance corrected visual acuity at distance (CDVA), intermediate (DCIVA), and near (DCNVA).
Time frame: 3 months postoperatively
Binocular photopic distance corrected defocus curve
Time frame: 3 months postoperatively
Monocular photopic distance corrected defocus curves
Time frame: 3 months postoperatively
Binocular mesopic distance corrected contrast sensitivity with and without glare (1.5, 3, 6 & 12 cpd)
Time frame: 3 months postoperatively
Refractive outcomes
Time frame: 3 months postoperatively
Pupil size
Time frame: 3 months postoperatively
Patient-reported outcomes using a questionnaire about visual disturbances (QUVID)
Time frame: 3 months postoperatively
Patient-reported outcomes using a questionnaire about IOL satisfaction (IOLSAT)
Time frame: 3 months postoperatively
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 30 Sep 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.
Morgan Micheletti, MD principal investigator
Berkeley Eye Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clareon PanOptix, Clareon PanOptix PRO and Mix-and-Match PanOptix/Vivity in people with Cataract, run by Berkeley Eye Center at 2 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 6 inclusion and 11 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 30 Sep 2026. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Tetiana Huff (713-620-7640, tetiana.huff@berkeleyeye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binocular photopic CDVA (corrected distance visual acuity) (time frame: 3 months postoperatively). 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 30 Sep 2026.