Panoptix Trifocal Lens in Post Refractive Myopic Laser Vision Correction Surgery

Launched by PARKHURST NUVISION CLINICAL RESEARCH LLC · Jan 5, 2021

Keywords

ClinConnect Summary

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 post-refractive who receive a PanOptix Trifocal IOL at the time of cataract surgery will be assessed. The bothersome visual symptom items of interest are halos, glare, and starbursts. Patients will also be assessed on level of glasses independence with an assessment of both corrected and uncorrected distance, intermediate, and near vision. Lastly patient satisfaction score will also be determin...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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
• • 2. 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.
• • 3. Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures
• • 4. Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.2 logMAR (Minimum Angle of Resolution) or better
• • 5. Calculated lens power within the available range
• • 6. Preoperative keratometric astigmatism at or less than 2.5 D in both operative eyes
• • 7. Clear intraocular media other than cataract in both eyes
• Exclusion Criteria:
• • 1. Clinically significant corneal abnormalities including corneal dystrophy, irregularity, inflammation or edema.
• • 2. Previous intraocular surgery other than myopic Lasik
• • 3. History of or current retinal conditions or predisposition to retinal conditions
• • 4. Amblyopia
• • 5. Rubella, congenital, traumatic, or complicated cataracts
• • 6. History of or current anterior or posterior segment inflammation of any etiology
• • 7. Iris neovascularization
• • 8. Glaucoma (uncontrolled or controlled with medication)
• • 9. Optic nerve atrophy
• • 10. Subjects with diagnosed degenerative eye disorders
• • 11. Pregnancy or lactation
• • 12. Any disease or pathology, other than cataract, that is expected to reduce the potential postoperative BCDVA to a level worse than 0.30 logMAR.