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RecruitingNCT06922084Updated Sep 30, 2026

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 interventional study of Clareon PanOptix and Clareon PanOptix PRO in Cataract, sponsored by Berkeley Eye Center. Recruiting at 2 sites in United States. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Berkeley Eye Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
320
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cataract

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03

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
320 participants (estimated)

Study arms

  • Active comparator
    Bilateral Clareon PanOptix IOL implantation

    Device: Clareon PanOptix

  • Experimental
    Bilateral Clareon PanOptix Pro IOL implantation

    Drug: Clareon PanOptix PRO

  • Experimental
    Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye

    Drug: Mix-and-Match PanOptix/Vivity

Interventions

  • DeviceClareon PanOptix

    Bilateral Clareon PanOptix IOL implantation

  • DrugClareon PanOptix PRO

    Bilateral Clareon PanOptix PRO IOL implantation

  • DrugMix-and-Match PanOptix/Vivity

    Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye

05

What researchers measure

Primary outcomes

  1. Binocular photopic CDVA (corrected distance visual acuity)

    Time frame: 3 months postoperatively

Secondary outcomes

  1. Binocular photopic DCIVA (distance corrected intermediate visual acuity) and DCNVA (distance corrected near visual acuity)

    Time frame: 3 months postoperatively

  2. Binocular photopic uncorrected visual acuity at distance (UDVA), intermediate (UIVA), and near (UNVA)

    Time frame: 3 months postoperatively

  3. Binocular photopic small letter contrast sensitivity at 66 cm and 100 cm with refractive distance correction (20/32 line)

    Time frame: 3 months postoperatively

  4. Binocular mesopic high contrast distance corrected visual acuity at distance (CDVA), intermediate (DCIVA), and near (DCNVA).

    Time frame: 3 months postoperatively

  5. 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.

    Time frame: 3 months postoperatively

  6. 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.

    Time frame: 3 months postoperatively

  7. Binocular mesopic distance corrected contrast sensitivity with and without glare (1.5, 3, 6 & 12 cpd)

    Time frame: 3 months postoperatively

  8. Refractive outcomes

    Mean residual manifest refraction spherical equivalent (MRSE) and residual astigmatism.

    Time frame: 3 months postoperatively

  9. Pupil size

    Under both photopic and mesopic conditions.

    Time frame: 3 months postoperatively

  10. Patient-reported outcomes using a questionnaire about visual disturbances (QUVID)

    Time frame: 3 months postoperatively

  11. Patient-reported outcomes using a questionnaire about IOL satisfaction (IOLSAT)

    Time frame: 3 months postoperatively

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Study locations

2 of 2 sites recruiting
  • Shafer Vision Institute
    Plymouth Meeting, Pennsylvania 19462, United States
    Recruiting
  • Berkeley Eye Center
    Houston, Texas 77027, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06922084
Lead sponsor
Berkeley Eye Center
Collaborators
Sengi
Responsible party
Sponsor
First posted
Apr 10, 2025
Start date
Mar 17, 2025
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

Tetiana Huff
Contact
tetiana.huff@berkeleyeye.com
713-620-7640
Morgan Micheletti, MD
principal investigator · Berkeley Eye Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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