To evaluate visual outcomes and patient satisfaction following bilateral implantation of the Clareon PanOptix versus Tecnis Odyssey IOL in patients undergoing cataract surgery
Multi-center, one-arm, ambispective pilot study with Odyssey IOL followed by a multi-center, prospective, randomized, two-arm, double-masked (subject and assessor), Clareon PanOptix vs TECNIS Odyssey comparative study with bilateral IOL implantation (endpoints or sample size may be modified after the pilot data analysis)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
266
Clareon® PanOptix® IOL models CNWTT0 and CNWTTx, x=3 \& 4 (BLF)
Tecnis® Odyssey® IOL models DRN00V, DRT150, DRT225
Hyperspeed LASIK
Rowland Heights, California, United States
Seeta Eye Center
Poughkeepsie, New York, United States
Texas Eye and Laser Center
Hurst, Texas, United States
Parkhurst Nuvision
San Antonio, Texas, United States
Binocular BCDVA
Binocular BCDVA at 4 m under photopic conditions
Time frame: At Visit 2 Month 3
Visual Acuity
Monocular BCDVA at 4 m under photopic conditions Monocular DCIVA at 60 cm under photopic conditions Monocular DCNVA at 33 cm under photopic conditions Monocular DCNVA at 40 cm under photopic conditions Binocular DCNVA at 33 cm under photopic conditions Binocular DCNVA at 40 cm under photopic conditions Binocular DCIVA at 60 cm under photopic conditions Binocular UDVA at 4 m under photopic conditions Binocular UIVA at 60 cm under photopic conditions Binocular UNVA at 40 cm under photopic conditions Binocular UNVA at 33 cm under photopic conditions Mean residual spherical equivalent (MRSE) Mean residual cylinder % of eyes achieving MRSE within ± 0.50 D of target (emmetropia) Mean area under binocular photopic best distance corrected defocus curves Mean area under monocular photopic best distance corrected defocus curves
Time frame: Visit 2 Month 3
Visual Acuity
Binocular DCNVA at 33 cm under mesopic conditions Binocular DCNVA at 40 cm under mesopic conditions Binocular DCIVA at 60 cm under mesopic conditions Low Contrast Binocular (25%) DCNVA at 40 cm under mesopic conditions Low Contrast Binocular (25%) DCNVA at 40 cm under photopic conditions Low Contrast Binocular (25%) DCIVA at 60 cm under mesopic conditions Low Contrast Binocular (25%) DCIVA at 60 cm under photopic conditions Binocular best distance corrected contrast sensitivity (with and without glare) measurements under photopic and mesopic conditions * patients complaining of bothersome visual disturbances (haloes glare and starbursts QUVID) * complete spectacle independence IOLSAT * patients who were satisfied with their vision IOLSAT
Time frame: Visit 2 Month 3
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.