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

NCT06922084 | Recruiting Phase 4 FDA Device

• 1 other identifier: 95474481
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Binocular photopic CDVA (corrected distance visual acuity)

  3 months postoperatively

Secondary Outcomes (11)

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

  3 months postoperatively

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

  3 months postoperatively

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

  3 months postoperatively

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

  3 months postoperatively

• Binocular photopic distance corrected defocus curve

  3 months postoperatively

Study Arms (3)

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

Interventions

Clareon PanOptix DEVICE

Bilateral Clareon PanOptix IOL implantation

Bilateral Clareon PanOptix IOL implantation

Clareon PanOptix PRO DRUG

Bilateral Clareon PanOptix PRO IOL implantation

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

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Berkeley Eye Center: lead
• Sengi: collaborator

Study Sites (2)

Shafer Vision Institute

Plymouth Meeting, Pennsylvania, 19462, United States

RECRUITING

Berkeley Eye Center

Houston, Texas, 77027, United States

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Morgan Micheletti, MD

  Berkeley Eye Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tetiana Huff

CONTACT

713-620-7640; tetiana.huff@berkeleyeye.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 10, 2025
• Study Start: March 17, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)