Prospective, randomized, multicenter, multi-arm, subject and vision-assessor-masked, two stage study with Stage 1 as a three-arm initial enrollment period, followed by Stage 2 as a head-to-head study refined based on the Stage 1 data.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
320
Bilateral Clareon PanOptix IOL implantation
Bilateral Clareon PanOptix PRO IOL implantation
Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye
Shafer Vision Institute
Plymouth Meeting, Pennsylvania, United States
RECRUITINGBerkeley Eye Center
Houston, Texas, United States
RECRUITINGBinocular photopic CDVA (corrected distance visual acuity)
Time frame: 3 months postoperatively
Binocular photopic DCIVA (distance corrected intermediate visual acuity) and DCNVA (distance corrected near visual acuity)
Time frame: 3 months postoperatively
Binocular photopic uncorrected visual acuity at distance (UDVA), intermediate (UIVA), and near (UNVA)
Time frame: 3 months postoperatively
Binocular photopic small letter contrast sensitivity at 66 cm and 100 cm with refractive distance correction (20/32 line)
Time frame: 3 months postoperatively
Binocular mesopic high contrast distance corrected visual acuity at distance (CDVA), intermediate (DCIVA), and near (DCNVA).
Time frame: 3 months postoperatively
Binocular photopic distance corrected defocus curve
Obtained by varying the vergence of the stimulus from -3.0 D to +1.0 D in steps of 0.5 D with the best correction for distance vision.
Time frame: 3 months postoperatively
Monocular photopic distance corrected defocus curves
Obtained by varying the vergence of the stimulus from -3.0 D to +1.0 D in steps of 0.5 D with the best correction for distance vision.
Time frame: 3 months postoperatively
Binocular mesopic distance corrected contrast sensitivity with and without glare (1.5, 3, 6 & 12 cpd)
Time frame: 3 months postoperatively
Refractive outcomes
Mean residual manifest refraction spherical equivalent (MRSE) and residual astigmatism.
Time frame: 3 months postoperatively
Pupil size
Under both photopic and mesopic conditions.
Time frame: 3 months postoperatively
Patient-reported outcomes using a questionnaire about visual disturbances (QUVID)
Time frame: 3 months postoperatively
Patient-reported outcomes using a questionnaire about IOL satisfaction (IOLSAT)
Time frame: 3 months postoperatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.