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

Visual and Refractive Outcomes of the Clareon PanOptix Pro IOL in Patients With Prior Myopic Refractive Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: Clareon PanOptix Pro IOL

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Zoe Baker, OD; Phone Number: 505-355-2020; Email: dr.baker@julietteeye.com

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87113
      • Recruiting
      • Juliette Eye Institute Research Center
      • Contact: Zoe Baker, OD; Phone Number: 505-355-2020; Email: dr.baker@julietteeye.com
      • Principal Investigator: Robert Melendez, MD, MBA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	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	The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.	3 months postoperative

Collaborators and Investigators

• Sponsor: Juliette Eye Institute Research Center
• Collaborators: Sengi
• Investigators: Principal Investigator: Robert Melendez, MD, MBA, Juliette Eye Institute Research Center

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 13, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: RM-24-01

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