Cataract
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAcrySof® IQ PanOptix®
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
DEVICESynergy®
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.
PROCEDURECataract Surgery
IOL implantation will be performed
Sponsors
Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Note: Ocular criteria must be met in both eyes. * are willing and able to understand and sign an informed consent; * are willing and able to attend all study visits; * Subjects diagnosed with bilateral cataracts with planned cataract removal by femto assisted phacoemulsification with a clear corneal incision and intraoperative aberrometry assisted * Clear intraocular media other than cataracts. * Projected BCDVA of better than 0.10 logMAR. * Preoperative regular keratometric astigmatism (by biometer) of less than or equal to 0.75D, in both eyes * Biometer IOL calculations within +6.0 - +30.0 power range
Exclusion criteria
If any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binocular DCNVA | Up to Month 6 | Binocular DCNVA of Trifocal (Alcon Panoptix) versus EDOF/Bifocal (Johnson and Johnson Tecnis Synergy) at 40 cm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Disturbances Evaluation by Questionnaire (QUVID) | Up to Month 6 | Patient reported visual disturbances by questionnaire (QUVID) postop |
| BCDVA and DCIVA (60 cm) | Up to Month 6 | Monocular and binocular BCDVA and DCIVA (60 cm) in both groups will be measured |
| DCNVA (40 cm) | Up to Month 6 | Monocular DCNVA (40 cm) in both groups will be measured |
| Visual Disturbances Evaluation | at all visits | Patient reported occurrences of visual disturbances of each group (unsolicited) at all visits |
| Visual Disturbances Evaluation by Questionnaire (IOL SAT) | Up to Month 6 | Patient satisfaction of each group by questionnaire (IOL SAT) postop |
| Defocus Curve | Up to Month 6 | Defocus curve tested in binocular photopic conditions (+1.00 to -3.00 in 0.50D except +0.50 to -0.50 in 0.25D) |
| Uncorrected Monocular and Binocular VA | Up to Month 6 | Uncorrected monocular and binocular VA at distance, intermediate (60 cm) and near (40 cm) |
Countries
United States
Contacts
Primary ContactSatish S Modi, MD
Backup ContactSarah O Piza
Outcome results
None listed