NCT05186298

Prospective Evaluation and Comparison of Bilateral Synergy Implants and Bilateral PanOptix Implants

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	AcrySof® 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
DEVICE	Synergy®	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.
PROCEDURE	Cataract Surgery	IOL implantation will be performed

Timeline

• Start date: 2021-11-02
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2022-01-11
• Last updated: 2022-01-11

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study