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NCT Number: NCT06922084

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shafer Vision Institute, Plymouth Meeting, Pennsylvania, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Clareon Panoptix

Device

Bilateral Clareon PanOptix IOL implantation

Clareon PanOptix PRO

Drug

Bilateral Clareon PanOptix PRO IOL implantation

Mix-and-Match PanOptix/Vivity

Drug

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

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

    Time frame: 3 months postoperatively

    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.

  6. Monocular photopic distance corrected defocus curves

    Time frame: 3 months postoperatively

    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.

  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

    Time frame: 3 months postoperatively

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

  9. Pupil size

    Time frame: 3 months postoperatively

    Under both photopic and mesopic conditions.

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Tetiana Huff

CONTACT

[email protected]

713-620-7640

Sponsors and collaborators

Lead sponsor

Berkeley Eye Center

Other

Collaborators

  • Sengi

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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