Outcomes of Clareon PanOptix Pro in Patients With Prior M... | NCT06555289

Studies
Outcomes of Clareon PanOptix Pro in Patients With Prior Myopic Refractive Surgery

NCT06555289

Sponsor

Juliette Eye Institute Research Center

Status

Recruiting

Last Update Posted

Dec 12, 2025Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Cataract

Interventions

Clareon PanOptix Pro IOL

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 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

Oct 23, 2024Actual

Primary Completion Date

Sep 1, 2026Estimated

Completion Date

Sep 1, 2026Estimated

First Submitted Date

Aug 13, 2024

First Submission Date that Met QC Criteria

Aug 13, 2024

First Posted Date

Aug 15, 2024Actual

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

Dec 5, 2025

Last Update Posted Date

Dec 12, 2025Actual

Name	Class
Sengi	INDUSTRY

Description Module

Brief Summary

This study is a Single center, single arm, prospective, observational study of clinical outcomes following bilateral cataract surgery and Clareon PanOptix Pro implantation. Subjects will be assessed preoperatively, and at 1 and 3 months postoperatively. Clinical evaluations will include administration of the QUVID and IOLSAT questionnaires, manifest refraction, topography, as well as measurement of visual acuities at distance, intermediate, and near.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
Clareon PanOptix Pro IOL	Device	Spherical and toric T3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Binocular corrected distance visual acuity (logMAR)		3 months postoperative

Secondary Outcomes

Measure	Description	Time Frame
Binocular distance corrected visual acuity at intermediate (logMAR)		3 months postoperative
Binocular distance corrected visual acuity at near (logMAR)		3 months postoperative

Other Outcomes

Measure	Description	Time Frame
Visual Disturbance Questionnaire	Questionnaire for Visual Disturbances (QUVID). Lower scores indicate less frequent, severe, or bothersome visual disturbances.	3 months postoperative
Satisfaction Questionnaire

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults (45 years or older) who have confirmed age-related cataracts and are eligible for bilateral cataract surgery.
Prior binocular myopic photorefractive keratectomy (PRK) or myopic LASIK.
Patients who have regular corneal astigmatism less than or equal to 0.6 D and are candidates for the PanOptix Pro spherical IOL.
Patients who have regular corneal astigmatism and are candidates for PanOptix Pro toric IOL T3
Postoperative visual potential of monocular 20/25 or better, in the surgeon's judgement.

Exclusion Criteria:

Any ocular comorbidity that might hamper postoperative visual acuity:
- Corneal abnormality including corneal dystrophy, irregularity, and degeneration.
- Moderate or severe dry eyes that can't be relieved after treatment.
- History of or current anterior and posterior inflammation of any etiology.
- Retinal pathology such as AMD, diabetic retinopathy, vein occlusion, etc.
- Glaucoma of any kind.
- Pregnancy or lactation.
Any ocular surgery other than corneal myopic refractive surgery (LASIK and PRK).
Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease, unable to fixate)
Apple Kappa/chord mu ≥ 0.6.
Higher order corneal aberrations at pupil diameter of 4mm: > 0.6 total RMS, > 0.3 coma, > 0.3 trefoil (to exclude irregular corneas)
Any patient requiring a limbal relaxing incision.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Eligible test subjects will be those with age-related cataracts and prior myopic refractive surgery.

Sampling Method

Non-Probability Sample

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases