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
- Are there results?
- None posted in the registry
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
Show all 14Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Treatment Clinical Evaluation of the ELITA Single Piece Patient Interface (PI) for Docking Procedure With the ELITA System
- ClinicalTrials.gov ID
- NCT06727799
- Acronym / sponsor ID
- CHTA110SDOK
- Conditions
- Refractive Error
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Test | – | Diagnostic Test: Docking Assessment / ObservationOne eye of each subject will have corneal marks placed and will be docked at the study visit. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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.)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docking Assessment / ObservationOne eye of each subject will have corneal marks placed and will be docked at the study visit. | Diagnostic test | Diagnostic Test |
Primary outcome
Successful Docking of Single PI using ELITA
Time frame: 1 month
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Error, run by Johnson & Johnson Surgical Vision, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Docking of Single PI using ELITA (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.