Presbyopia Clinical Trial
Official title:
Contralateral Study of Clareon PanOptix Pro vs. Clareon PanOptix
NCT number | NCT06401551 |
Other study ID # | ILQ137-C002-B |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 18, 2024 |
Est. completion date | July 2025 |
The purpose of this study is to evaluate the safety and effectiveness of Clareon™ PanOptix™ Pro Trifocal Intraocular Lens (IOL) compared to Clareon™ PanOptix™ Trifocal IOL.
Status | Recruiting |
Enrollment | 79 |
Est. completion date | July 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years and older |
Eligibility | Key Inclusion Criteria: - Understand and sign an ethics committee-approved informed consent form; - Willing and able to attend all scheduled study visits as required by the protocol; - Planned cataract surgery (both eyes); - Preoperative corneal astigmatism less that 1.00 diopter in each eye. - Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: - Women of childbearing potential if currently pregnant, intend to become pregnant during the study, or are breastfeeding; - Ocular conditions as specified in the protocol; - Subjects who desire monovision correction. - Other protocol-defined exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
United States | Grosinger, Spigelman & Grey Eye Surgeons, P.C. | Bloomfield Hills | Michigan |
United States | Carolina Eye Care Physicians | Charleston | South Carolina |
United States | Cincinnati Eye Institute | Cincinnati | Ohio |
United States | Houston Eye Associates | Houston | Texas |
United States | Moyes Eye Center | Kansas City | Missouri |
United States | Vision for Life | Nashville | Tennessee |
United States | The Eye Institute of Utah | Salt Lake City | Utah |
United States | Wolstan & Goldberg Eye Associates | Torrance | California |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) | Visual Acuity (VA) will be assessed for each eye individually 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. | Month 2 postoperative |
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