Status:
UNKNOWN
Panoptix Trifocal Lens in Post Refractive Myopic Laser Vision Correction Surgery
Lead Sponsor:
Parkhurst NuVision Clinical Research LLC
Collaborating Sponsors:
Alcon Research
Conditions:
Cataract
Refractive Errors
Eligibility:
All Genders
22+ years
Brief Summary
The two main objectives of this study are to demonstrate safety and effectiveness of implanting the PanOptix Trifocal IOL in patients who have had previous myopic Lasik. The primary objectives to demo...
Detailed Description
Clinical Hypothesis: The rate of bothersome visual symptom items (defined as a very or extremely bothersome visual symptom that impacts daily living under overall condition) for the patients who are ...
Eligibility Criteria
Inclusion
- Adults, 22 years of age or older at the time of surgery, diagnosed with bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision
- Previous myopic Lasik with a well centered optical zone, corneal higher-order aberrations less than 0.6 um for a 4 mm pupil (measured by iTrace), and a minimum keratometric reading of 35.0 D.
- Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures
- Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.2 logMAR (Minimum Angle of Resolution) or better
- Calculated lens power within the available range
- Preoperative keratometric astigmatism at or less than 2.5 D in both operative eyes
- Clear intraocular media other than cataract in both eyes
Exclusion
- Clinically significant corneal abnormalities including corneal dystrophy, irregularity, inflammation or edema.
- Previous intraocular surgery other than myopic Lasik
- History of or current retinal conditions or predisposition to retinal conditions
- Amblyopia
- Rubella, congenital, traumatic, or complicated cataracts
- History of or current anterior or posterior segment inflammation of any etiology
- Iris neovascularization
- Glaucoma (uncontrolled or controlled with medication)
- Optic nerve atrophy
- Subjects with diagnosed degenerative eye disorders
- Pregnancy or lactation
- Any disease or pathology, other than cataract, that is expected to reduce the potential postoperative BCDVA to a level worse than 0.30 logMAR.
Key Trial Info
Start Date :
March 8 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04698278
Start Date
March 8 2021
End Date
July 1 2022
Last Update
March 17 2021
Active Locations (1)
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1
Parkhurst NuVision
San Antonio, Texas, United States, 78229