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

NCT05713253 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-03-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Johnson & Johnson Surgical Vision, Inc.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Surgical Vision, Inc. Clinical Trials · Johnson & Johnson Surgical Vision, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-02
Primary Completion
2025-02-21
Completion
2025-02-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05713253 on ClinicalTrials.gov