NCT06555289 Outcomes of Clareon PanOptix Pro in Patients With Prior Myopic Refractive Surgery
| NCT ID | NCT06555289 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Juliette Eye Institute Research Center |
| Condition | Cataract |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-10-23 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2024-10-23 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Robert Melendez, MD, MBA
PRINCIPAL INVESTIGATOR
Juliette Eye Institute Research Center
Frequently Asked Questions
Who can join the NCT06555289 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Cataract. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06555289 currently recruiting?
Yes, NCT06555289 is actively recruiting participants. Contact the research team at dr.baker@julietteeye.com for enrollment information.
Where is the NCT06555289 trial being conducted?
This trial is being conducted at Albuquerque, United States.
Who is sponsoring the NCT06555289 clinical trial?
NCT06555289 is sponsored by Juliette Eye Institute Research Center. The principal investigator is Robert Melendez, MD, MBA at Juliette Eye Institute Research Center. The trial plans to enroll 40 participants.