NCT05396599

A Clinical Study Comparing Postoperative Outcomes Between the TECNIS Intraocular Lens.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Johnson & Johnson Surgical Vision, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, masked, three-arm, randomized clinical study of the TECNIS Eyhance Toric II IOL (test #1) and TECNIS Synergy Toric II (test #2) compared to the TECNIS Toric 1-Piece IOL (control).

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Model DIU	Subjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted.
DEVICE	Model DFW	Subjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted.
DEVICE	Model ZCT	Subjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted.

Timeline

• Start date: 2022-06-30
• Primary completion: 2023-04-07
• Completion: 2023-04-07
• First posted: 2022-05-31
• Last updated: 2024-06-04
• Results posted: 2024-06-04

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study