Status:
RECRUITING
Outcomes of Clareon PanOptix Pro in Patients With Prior Myopic Refractive Surgery
Lead Sponsor:
Juliette Eye Institute Research Center
Collaborating Sponsors:
Sengi
Conditions:
Cataract
Eligibility:
All Genders
45+ years
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 23 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06555289
Start Date
October 23 2024
End Date
September 1 2026
Last Update
December 12 2025
Active Locations (1)
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1
Juliette Eye Institute Research Center
Albuquerque, New Mexico, United States, 87113