Aphakia, Cataract
Conditions
Brief summary
The purpose of this study is to understand the visual outcomes of the investigational intraocular lens (IOL) Model LPYWT0 when compared to the commercially marketed Clareon PanOptix Pro IOL Model PXYWT0.
Detailed description
In this study, subjects with cataracts in both eyes will undergo cataract surgery and be implanted with trifocal IOLs. One eye will receive the investigational IOL Model LPYWT0 IOL, and the other eye will receive the commercially marketed Clareon PanOptix Pro IOL Model PXYWT0. The second eye surgery will occur 7-14 days after the first. Subjects will attend 9 planned study visits to include for an individual duration of participation of approximately 7 months. This study is planned to be conducted in India and the Philippines.
Interventions
DEVICELPYWT0
Investigational blue light filtering trifocal IOL implanted in the capsular bag of the eye during cataract surgery intended to remain in the eye for the lifetime of the subject.
DEVICEPXYWT0
Commercially available blue light filtering trifocal IOL implanted in the capsular bag of the eye during cataract surgery intended to remain in the eye for the lifetime of the subject.
PROCEDURECataract Surgery
Removal of the cataractous lens by phacoemulsification followed by implantation of the IOL
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * The calculated power needed for the artificial lens (IOL) must be between +15.0 and +25.0 D in each eye, designed to bring subject vision as close to "0.0" (neutral) as possible, meaning they will not be strongly nearsighted or farsighted after surgery. * Subjects must have low levels of astigmatism (misshapen cornea) in the eyes (less than 1.00 D). * In the doctor's opinion, the subjects have the potential to achieve good vision (0.2 logMAR, which is roughly 20/32 Snellen or better) in each eye after the surgery, when wearing the best possible spectacles or contact lenses. * Other protocol-specified inclusion criteria may apply. Key
Exclusion criteria
* Clinically significant corneal diseases which may, according to the investigator's medical opinion, adversely affect visual outcomes. * Any ocular or systemic health condition or medical issue that, in the investigator's medical opinion, could make the study results unreliable, prevent the person from finishing the study, or increase their safety risk. * People who want to have one eye set for distance vision and the other for near vision. * The doctor expects significant blurry vision (astigmatism) after the procedure. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) | Month 6 postoperative | Visual Acuity will be assessed using letter charts under well-lit (photopic) conditions with correction in place at a distance of 4 meters from the subject. BCDVA will be recorded in logarithm minimum angle of resolution (logMAR) where 0.0 logMAR is equivalent to 20/20 Snellen, or normal distance eyesight, and negative logMAR values represent better-than-normal distance eyesight. |
Countries
India, Philippines
Contacts
CONTACTAlcon Call Center
STUDY_DIRECTORClinical Trial Lead, Surgical
Alcon Research, LLC
Outcome results
None listed