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

Johnson & Johnson (J&J)

Status

Completed

Conditions

Refractive Error

Treatments

Diagnostic Test: Docking Assessment / Observation

Study type

Observational

Funder types

Industry

Identifiers

NCT06727799

CHTA110SDOK

Details and patient eligibility

About

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

Enrollment

55 patients

Sex

All

Ages

22+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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