Aphakia, Presbyopia
Conditions
Keywords
Cataract, Eye Surgery
Brief summary
The purpose of this study is to collect safety and performance data on two approved intraocular lenses (IOLs). This study will be conducted in participants who require cataract surgery in both eyes. The IOLs are designed to provide vision at far, arm's length, and near.
Detailed description
Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 7 months. Both eyes will undergo cataract surgery. The second eye surgery will occur within 7 to 14 days of the first.
Interventions
DEVICEClareon PanOptix Pro/Pro Toric Trifocal IOL
Intraocular lens (IOL) placed into the lens capsule of the eye during cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the pseudophakic subject.
PROCEDUREPhacoemulsification
Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for IOL implantation.
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Subjects with cataracts in both eyes, planned for removal by routine surgery (phacoemulsification); * Subject must be able to understand and sign an approved informed consent form; * Subject is willing to complete all the required study visits for the duration of the study; * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Ocular conditions as specified in the protocol; * Subjects who desire monovision correction; * Previous intraocular or corneal surgery; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) | Month 1 and Month 6 postoperative | Visual Acuity (VA) will be assessed for both eyes together (binocular) using Early Treatment Diabetic Retinopathy Study (ETDRS) reading charts at a distance of 4 meters from the subject under photopic (well-lit) conditions with correction in place. BCDVA will be measured in logarithm Minimum Angle of Resolution (logMAR). LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision), with lower scores indicating better vision. |
Countries
United States
Contacts
STUDY_DIRECTORSr. Principal Clinical Trial Operations, Surgical
Alcon Research LLC
Outcome results
None listed