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

NCT06555289 | Recruiting FDA Device

• 1 other identifier: RM-24-01
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Binocular corrected distance visual acuity (logMAR)

  3 months postoperative

Secondary Outcomes (5)

• 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 Outcomes (2)

• Visual Disturbance Questionnaire

  3 months postoperative

• Satisfaction Questionnaire

  3 months postoperative

Interventions

Clareon PanOptix Pro IOL DEVICE

Spherical and toric T3

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Juliette Eye Institute Research Center: lead
• Sengi: collaborator

Study Sites (1)

Juliette Eye Institute Research Center

Albuquerque, New Mexico, 87113, United States

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Robert Melendez, MD, MBA

  Juliette Eye Institute Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoe Baker, OD

CONTACT

505-355-2020; dr.baker@julietteeye.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 15, 2024
• Study Start: October 23, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)