Refractive ErrorNCT06727799
A Non-Treatment Clinical Evaluation of the ELITA Single Piece Patient Interface for Docking Procedure With the ELITA
An observational study of Refractive Error, run by Johnson & Johnson Surgical Vision, Inc. at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractive Error
- What is being tested?
- Docking Assessment / Observation
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Dec 2024to 28 Mar 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hoopes Vision
Draper, Utah, 84020
Stanford Eye Laser Center
Palo Alto, California, 94303
About this study
Official title: 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
- Conditions
- Refractive Error
- Being tested
- Docking Assessment / Observation
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docking Assessment / ObservationDiagnostic test
One eye of each subject will have corneal marks placed and will be docked at the study visit.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Test | One eye of each subject will have corneal marks placed and will be docked at the study visit. Receives: Diagnostic Test: Docking Assessment / Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start6 Dec 2024
- Primary completion28 Mar 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727799
- Sponsor's protocol ID
- CHTA110SDOK
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2024
- Last updated
- 11 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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