NCT04156737

A Comparative Study of TECNIS Symfony Plus IOL and a Trifocal IOL

A Comparative Clinical Evaluation of a New TECNIS® Presbyopia-correcting Intraocular Lens Against a Trifocal Intraocular Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Johnson & Johnson Surgical Vision, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, prospective, randomized, subject- and evaluator-masked, bilateral-implant study conducted at up to 15 sites worldwide. A total of up to 280 subjects will be randomized in a 1:1 ratio for implantation with either the TECNIS Symfony plus IOL Model ZHR00V or the Trifocal IOL. This will ensure that data from at least 100 subjects in the TECNIS Symfony plus lens group and at least 100 subjects in the Trifocal lens group will be available for analysis at the 6-month follow-up timepoint. All subjects will be followed for up to 6 months postoperative.

Conditions

• Cataract
• Refractive Error

Interventions

Type	Name	Description
DEVICE	TECNIS Symfony plus IOL Model ZHR00V	IOL replaces the natural lens removed during cataract surgery
DEVICE	Trifocal Intraocular lens	IOL replaces the natural lens removed during cataract surgery

Timeline

• Start date: 2020-01-24
• Primary completion: 2021-07-14
• Completion: 2021-07-14
• First posted: 2019-11-07
• Last updated: 2021-08-05

Locations

5 sites across 3 countries: New Zealand, Philippines, Spain