Intraocular Lens Implant
DeviceClareon® PanOptix® IOL models CNWTT0 and CNWTTx, x=3 & 4 (BLF)
NCT Number: NCT07768475
To evaluate visual outcomes and patient satisfaction following bilateral implantation of the Clareon PanOptix versus Tecnis Odyssey IOL in patients undergoing cataract surgery
This study is active but is not currently recruiting participants.
Notify MeAll sexes
Interventional
Not applicable
Hyperspeed LASIK, Rowland Heights, California, United States
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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Clareon® PanOptix® IOL models CNWTT0 and CNWTTx, x=3 & 4 (BLF)
Time frame: At Visit 2 Month 3
Binocular BCDVA at 4 m under photopic conditions
Time frame: Visit 2 Month 3
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
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
Nvision Laser Eye Centers
Industry
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