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

Phase 4

Recruiting

• Conditions: Cataract
• Interventions: Device: Clareon PanOptix; Drug: Mix-and-Match PanOptix/Vivity; Drug: Clareon PanOptix PRO

• Registration Number: NCT06922084
• Lead Sponsor: Berkeley Eye Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-17
• Study First Submitted: 2025-03-28
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-10
• Last Update Posted: 2025-04-10
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 320

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bilateral Clareon PanOptix IOL implantation	Clareon PanOptix	-
Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye	Mix-and-Match PanOptix/Vivity	-
Bilateral Clareon PanOptix Pro IOL implantation	Clareon PanOptix PRO	-

Primary Outcome Measures

Name	Time	Method
Binocular photopic CDVA (corrected distance visual acuity)	3 months postoperatively

Secondary Outcome Measures

Name	Time	Method
Binocular photopic DCIVA (distance corrected intermediate visual acuity) and DCNVA (distance corrected near visual acuity)	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
Refractive outcomes	3 months postoperatively	Mean residual manifest refraction spherical equivalent (MRSE) and residual astigmatism.
Pupil size	3 months postoperatively	Under both photopic and mesopic conditions.
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
Binocular photopic uncorrected visual acuity at distance (UDVA), intermediate (UIVA), and near (UNVA)	3 months postoperatively
Binocular photopic distance corrected defocus curve	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.
Monocular photopic distance corrected defocus curves	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.
Binocular mesopic distance corrected contrast sensitivity with and without glare (1.5, 3, 6 & 12 cpd)	3 months postoperatively

Trial Locations

Locations (2)

Shafer Vision Institute; 🇺🇸 Plymouth Meeting, Pennsylvania, United States

Berkeley Eye Center; 🇺🇸 Houston, Texas, United States