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.

Study Overview

• Status: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: Clareon PanOptix; Drug: Clareon PanOptix PRO; Drug: Mix-and-Match PanOptix/Vivity

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Tetiana Huff; Phone Number: 713-620-7640; Email: tetiana.huff@berkeleyeye.com

Study Locations

• United States
  • Pennsylvania
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Recruiting
      • Shafer Vision Institute
      • Contact: Ailinn Dunn; Email: ailinn@shafervision.com
      • Principal Investigator: Brian Shafer
  • Texas
    • Houston, Texas, United States, 77027
      • Recruiting
      • Berkeley Eye Center
      • Principal Investigator: Morgan Micheletti, MD
      • Contact: Tetiana Huff; Phone Number: 713-620-7640; Email: tetiana.huff@berkeleyeye.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bilateral Clareon PanOptix IOL implantation	Device: Clareon PanOptix; Bilateral Clareon PanOptix IOL implantation
Experimental: Bilateral Clareon PanOptix Pro IOL implantation	Drug: Clareon PanOptix PRO; Bilateral Clareon PanOptix PRO IOL implantation
Experimental: Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye	Drug: Mix-and-Match PanOptix/Vivity; Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Binocular photopic CDVA (corrected distance visual acuity)	3 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	3 months postoperatively
Binocular mesopic distance corrected contrast sensitivity with and without glare (1.5, 3, 6 & 12 cpd)		3 months postoperatively
Refractive outcomes	Mean residual manifest refraction spherical equivalent (MRSE) and residual astigmatism.	3 months postoperatively
Pupil size	Under both photopic and mesopic conditions.	3 months postoperatively
Patient-reported outcomes using a questionnaire about visual disturbances (QUVID)		3 months postoperatively
Patient-reported outcomes using a questionnaire about IOL satisfaction (IOLSAT)		3 months postoperatively

Collaborators and Investigators

• Sponsor: Berkeley Eye Center
• Collaborators: Sengi
• Investigators: Principal Investigator: Morgan Micheletti, MD, Berkeley Eye Center

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 28, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 95474481

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes