Clinical trial NCT06727799: A Non-Treatment Clinical Evaluation of the ELITA Single Piece Patient Interface for Docking Procedure With the ELITA
Official title: A Non-Treatment Clinical Evaluation of the ELITA Single Piece Patient Interface (PI) for Docking Procedure With the ELITA System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractive Error
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-11
Enrollment: 55
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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


Eligibility 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

Primary outcomes:
measure: Successful Docking of Single PI using ELITA
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Eye Laser Center
state: California
city: Draper
country: United States
facility: Hoopes Vision
state: Utah
Study officials:
References: