Outcomes of Clareon PanOptix in Patients With Prior Myopic Refractive Surgery
Purpose
This study is a Single center, single arm, prospective, observational study of clinical outcomes following bilateral cataract surgery and Clareon PanOptix 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.
Condition
- Cataract
Eligibility
- Eligible Ages
- Over 45 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 spherical IOL. - Patients who have regular corneal astigmatism and are candidates for PanOptix 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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
Juliette Eye Institute Research Center
Albuquerque, New Mexico 87113
Albuquerque, New Mexico 87113
More Details
- NCT ID
- NCT06555289
- Status
- Recruiting
- Sponsor
- Juliette Eye Institute Research Center