The purpose of this study is to evaluate the AcrySof PanOptix Intraocular Lens (IOL) for binocular distance corrected near visual acuity (DCNVA) compared to TECNIS Synergy IOL. Presbyopia correcting diffractive intraocular implants (extended depth of focus, multifocal, and trifocal) provide cataract and refractive surgeons with an effective treatment means for allowing patients to experience increased spectacle independence post-cataract surgery.
Eligible test subjects will be patients diagnosed with cataracts bilaterally who are interested and eligible for implantation of a presbyopia-correcting multifocal intraocular lenses. Subjects will participate in ten study visits. Visits will include a screening visit (both eyes evaluated), one operative visit for each eye, and 7 postoperative visits. Both eyes will be implanted, with the second eye surgery occurring X (depends on the patient and the schedule) days after the first.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
320
The AcrySof IQ PanOptix® (Alcon) mitigates the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity with a reduced need for eyeglasses, compared to a monofocal IOL
The TECNIS Synergy™ IOLs mitigate the effects of presbyopia by providing far vision comparable to an aspheric monofocal IOL. Compared to an aspheric monofocal IOL, the lens provides significantly improved intermediate and near vision, including in low-light conditions.
IOL implantation will be performed
Eye Care Now
Panama City, Florida, United States
RECRUITINGSeeta Eye Center
Poughkeepsie, New York, United States
RECRUITINGEye Care Specialists
Kingston, Pennsylvania, United States
Binocular DCNVA
Binocular DCNVA of Trifocal (Alcon Panoptix) versus EDOF/Bifocal (Johnson and Johnson Tecnis Synergy) at 40 cm
Time frame: Up to Month 6
Visual Disturbances Evaluation
Patient reported occurrences of visual disturbances of each group (unsolicited) at all visits
Time frame: at all visits
Visual Disturbances Evaluation by Questionnaire (QUVID)
Patient reported visual disturbances by questionnaire (QUVID) postop
Time frame: Up to Month 6
BCDVA and DCIVA (60 cm)
Monocular and binocular BCDVA and DCIVA (60 cm) in both groups will be measured
Time frame: Up to Month 6
DCNVA (40 cm)
Monocular DCNVA (40 cm) in both groups will be measured
Time frame: Up to Month 6
Uncorrected Monocular and Binocular VA
Uncorrected monocular and binocular VA at distance, intermediate (60 cm) and near (40 cm)
Time frame: Up to Month 6
Visual Disturbances Evaluation by Questionnaire (IOL SAT)
Patient satisfaction of each group by questionnaire (IOL SAT) postop
Time frame: Up to Month 6
Defocus Curve
Defocus curve tested in binocular photopic conditions (+1.00 to -3.00 in 0.50D except +0.50 to -0.50 in 0.25D)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Lehmann Eye Center
Nacogdoches, Texas, United States
RECRUITINGNorthwest Eye Surgeons
Seattle, Washington, United States
RECRUITINGTime frame: Up to Month 6