NCT05713253

A PHASED, PROSPECTIVE, MULTI-CENTER STUDY OF THE ELITA SYSTEM

A PHASED, PROSPECTIVE, MULTI-CENTER STUDY OF THE ELITA SYSTEM FOR THE REDUCTION OR ELIMINATION OF MYOPIC REFRACTIVE ERRORS WITH OR WITHOUT ASTIGMATISM

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Johnson & Johnson Surgical Vision, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This study will be a 2-phase, prospective, multicenter, open-label, non-comparative, non-randomized clinical investigation to confirm the safety and effectiveness of the ELITA system.

Conditions

• Refractive Error

Interventions

Type	Name	Description
DEVICE	ELITA System	Each subject will receive a SILK lenticule removal procedure on one eye and a commercially available laser vision correction procedure on their fellow eye (Feasibility Phase). Subjects will receive a lenticule removal procedure on both eyes to reduce or eliminate myopic refractive errors (Pivotal Phase). The second eye treatment will be considered only after the first eye 1-week follow up visit has been completed and safety criteria are met.

Timeline

• Start date: 2023-02-02
• Primary completion: 2025-02-21
• Completion: 2025-02-21
• First posted: 2023-02-06
• Last updated: 2026-03-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study