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

NCT06727799 | Completed FDA Device

• 1 other identifier: CHTA110SDOK
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Refractive Error

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Docking Assessment / Observation DIAGNOSTIC_TEST

One eye of each subject will have corneal marks placed and will be docked at the study visit.

Diagnostic Test

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (2)

Stanford Eye Laser Center

Palo Alto, California, 94303, United States

Location

Hoopes Vision

Draper, Utah, 84020, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 11, 2024
• Study Start: December 6, 2024
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (2)