A Prospective, Randomized, Subject and Vision-assessor Ma... | NCT06922084

Studies
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

Sponsor

Berkeley Eye Center

Status

Recruiting

Last Update Posted

Apr 10, 2025Actual

Enrollment

320Estimated

Phase

Phase 4

Conditions

Cataract

Interventions

Clareon PanOptix
Clareon PanOptix PRO
Mix-and-Match PanOptix/Vivity

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 17, 2025Actual

Primary Completion Date

Apr 2026Estimated

Completion Date

Apr 2026Estimated

First Submitted Date

Mar 28, 2025

First Submission Date that Met QC Criteria

Apr 3, 2025

First Posted Date

Apr 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2025

Last Update Posted Date

Apr 10, 2025Actual

Name	Class
Sengi	INDUSTRY

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

320Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Clareon PanOptix	Device	Bilateral Clareon PanOptix IOL implantation	Bilateral Clareon PanOptix IOL implantation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases