A Non-Treatment Clinical Evaluation of the ELITA Single Piece Patient Interface for Docking Procedure With the ELITA

A Non-Treatment Clinical Evaluation of the ELITA Single Piece Patient Interface (PI) for Docking Procedure With the ELITA System

Open label, prospective, randomized, multicenter, measurement only feasibility study to evaluate the docking procedure using the ELITA Single Piece Patient interface in conjunction with the ELITA system

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Diagnostic test: Docking Assessment / Observation

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94303
      • Stanford Eye Laser Center
  • Utah
    • Draper, Utah, United States, 84020
      • Hoopes Vision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

During the evaluation phase, approximately 50 eyes, with a minimum of 20 eyes of East Asian descent (based on demographics) will be enrolled.

During the confirmation phase, approximately 50 eyes, with a minimum of 20 eyes of East Asian descent (based on demographics) will be enrolled.

Description

Inclusion Criteria: All criteria apply to both eyes:

• Minimum 22 years of age at the time the informed consent form is signed
• Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
• Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the USA/State
• Ability to understand and respond to a questionnaire in English

Exclusion Criteria: All criteria apply to both eyes:

• History of prior corneal refractive surgery (LASIK, LASEK, RK, PRK, SMILE, etc.), intraocular surgery, cataract extraction or corneal transplant surgery (DSEK, DMEK, DALK, PKP, etc.)

  • History of corneal abnormalities such as stromal, epithelial, or endothelial dystrophies or retinal abnormalities, retinal degeneration or other abnormalities
  • Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
  • History of or active ophthalmic disease or abnormality (including, but not limited to, symptomatic blepharitis, recurrent corneal erosion, clinically significant dry eye syndrome or symptoms, neovascularization > 1 mm from limbus), retinal detachment/repair (including but not limited to any curative or preventative laser treatment of holes, tears, or lattice degeneration), clinically significant lens opacity, clinical evidence of trauma, corneal opacity within the central 9 mm and visible on topography, at risk for developing strabismus, or with evidence of glaucoma or propensity for narrow angle glaucoma
  • Ocular hypertension (IOP > 21 mmHg), glaucoma, glaucoma suspect, or subjects taking any medication for these conditions
  • Any abnormality of the optic nerve or vasculature by history or direct evaluation
  • History or current diagnosis of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, endocrine disorders (including, but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis.

NOTE: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity, or control, will specifically exclude subjects from eligibility.

Subjects with active ocular infection

• Use of systemic or ocular medications that may affect vision
• Known sensitivity or inappropriate responsiveness to any of the medications used in the study Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.) History or presence of amblyopia
• Concurrent participation or participation in an interventional (i.e., surgical or pharmaceutical interventional) clinical trial within 14 days prior to the 1st study visit.

Subject who is known to be pregnant or breast feeding

• Subjects who belong to vulnerable populations, including but not limited to minors, pregnant individuals, individuals with cognitive impairments, employees of the clinical site or JJV and their immediate family members (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse), individuals unable to provide inform consent, and those who may be subject to coercion or undue influence

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diagnostic Test; One eye of each subject will have corneal marks placed and will be docked at the study visit.	Diagnostic test: Docking Assessment / Observation; One eye of each subject will have corneal marks placed and will be docked at the study visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Docking of Single PI using ELITA	Applanation of the cornea with the Patient interface resulting meniscus formation at PI interface of at least 10 mm in diameter with continuous vacuum suction engaged and no observed eye movement upon successful vacuum engagement that allows centration of a 9 mm flap based on GUI overlay on the centration screen	1 month

Collaborators and Investigators

• Sponsor: Johnson & Johnson Surgical Vision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2024
• Primary Completion (Actual): March 28, 2025
• Study Completion (Actual): March 28, 2025

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Actual): December 11, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CHTA110SDOK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No