NCT06555289 · Juliette Eye Institute Research Center
Outcomes of Clareon PanOptix Pro in Patients With Prior Myopic Refractive Surgery
What this study is about
This study is a Single center, single treatment group$1, forward-looking, 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.
View original scientific description
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.
Interventions
DEVICE
Clareon PanOptix Pro IOL
Spherical and toric T3
Primary outcome measures
Binocular corrected distance visual acuity (logMAR)
Time frame: 3 months postoperative
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Albuquerque, New Mexico
Collaborators
Sengi
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 12, 2025 · Source of record for eligibility and locations