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NCT Number: NCT06555289

Outcomes of Clareon PanOptix Pro 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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Juliette Eye Institute Research Center

Albuquerque, New Mexico, 87113, United States

Location status: Recruiting

Location contact

Robert Melendez, MD, MBA

PRINCIPAL_INVESTIGATOR

Zoe Baker, OD

CONTACT

[email protected]

505-355-2020

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clareon PanOptix Pro IOL

Device

Spherical and toric T3

Primary outcomes

  1. Binocular corrected distance visual acuity (logMAR)

    Time frame: 3 months postoperative

Secondary outcomes

  1. Binocular distance corrected visual acuity at intermediate (logMAR)

    Time frame: 3 months postoperative

  2. Binocular distance corrected visual acuity at near (logMAR)

    Time frame: 3 months postoperative

  3. Binocular unccorrected visual acuity at distance (logMAR)

    Time frame: 3 months postoperative

  4. Binocular unccorrected visual acuity at intermediate (logMAR)

    Time frame: 3 months postoperative

  5. Binocular unccorrected visual acuity at near (logMAR)

    Time frame: 3 months postoperative

Other outcomes

  1. Visual Disturbance Questionnaire

    Time frame: 3 months postoperative

    Questionnaire for Visual Disturbances (QUVID). Lower scores indicate less frequent, severe, or bothersome visual disturbances.

  2. Satisfaction Questionnaire

    Time frame: 3 months postoperative

    The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction.

Study contacts

Contact information is provided by the study sponsor or research team.

Zoe Baker, OD

CONTACT

[email protected]

505-355-2020

Sponsors and collaborators

Lead sponsor

Juliette Eye Institute Research Center

Other

Collaborators

  • Sengi

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2024
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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