Cataract
Conditions
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.
Interventions
DEVICEClareon PanOptix Pro IOL
Spherical and toric T3
Sponsors
Sengi
Juliette Eye Institute Research Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Binocular corrected distance visual acuity (logMAR) | 3 months postoperative |
Secondary
| Measure | Time frame |
|---|---|
| Binocular distance corrected visual acuity at intermediate (logMAR) | 3 months postoperative |
| Binocular distance corrected visual acuity at near (logMAR) | 3 months postoperative |
| Binocular unccorrected visual acuity at distance (logMAR) | 3 months postoperative |
| Binocular unccorrected visual acuity at intermediate (logMAR) | 3 months postoperative |
| Binocular unccorrected visual acuity at near (logMAR) | 3 months postoperative |
Other
| Measure | Time frame | Description |
|---|---|---|
| Visual Disturbance Questionnaire | 3 months postoperative | Questionnaire for Visual Disturbances (QUVID). Lower scores indicate less frequent, severe, or bothersome visual disturbances. |
| Satisfaction Questionnaire | 3 months postoperative | The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction. |
Countries
United States
Contacts
Primary ContactZoe Baker, OD
Outcome results
None listed