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Refractive ErrorNCT05713253

A PHASED, PROSPECTIVE, MULTI-CENTER STUDY OF THE ELITA SYSTEM

A study testing ELITA System in people with Refractive Error, run by Johnson & Johnson Surgical Vision, Inc. at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will be a 2-phase, prospective, multicenter, open-label, non-comparative, non-randomized clinical investigation to confirm the safety and effectiveness of the ELITA system. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Refractive Error
What is being tested?
ELITA System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
2 sitesUnited States
Study dates
2 Feb 2023to 21 Feb 2025
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be considered for enrollment, subject must:
  • Age ≥22 years old.
  • Subjects with myopic refractive error up to -10.00 D sphere and astigmatism up to -5.00 D with the sum of sphere and cylinder between -1.00 D and -10.00 D using minus cylinder convention based on manifest refraction.
  • Anticipated residual corneal stromal thickness of at least 250 microns based on preoperative corneal pachymetry minus calculated maximum lenticule thickness to be extracted.
  • Uncorrected visual acuity of 20/40 or worse.
  • Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better.
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  • BSCVA ≥2 lines (≥10 letters) better than distance Uncorrected Visual Acuity (UCVA).
  • Less than or equal to 0.75 D difference between cycloplegic and manifest refraction sphere.
  • A stable refractive error (based on a previous exam, medical records, lensometry, or prescription at least 12 months prior to the preoperative manifest refraction), as defined by a change of ≤0.50 D in MRSE and ≤0.50 D in MRC. Additionally, the astigmatic axis must also be within 15 degrees for eyes with >0.50 D of preoperative and historical manifest cylinder.
  • Any subject eye with a history of contact lens wear within the last 4 weeks must demonstrate refractive stability according to the following:
  • Rigid, toric, or extended wear contact lenses (toric or spherical) must be removed for at least 2 weeks and soft contact lenses (spherical) for at least 3 days prior to the first refraction used to establish stability.
  • Two consecutive manifest refractions and keratometry readings must be conducted at least 7 days apart.
  • Refractive stability is defined as a change of not more than 0.50 D in manifest refractive sphere and cylinder as well as keratometry meridian (either axis) between measurements.
  • If the subject meets the refractive stability criteria, contact lens wear is not permitted for 2 weeks (rigid/toric/extended wear) or 3 days (soft) prior to surgery 14. Willing and capable of complying with follow-up examinations for the duration of the study.
  • 15. Signed informed consent or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment.

Who cannot join

  • Subjects will not be eligible to take part in the study if subjects:
  • Concurrent use of systemic (including inhaled) medications that may impair healing, including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of treatment.
  • NOTE: The use of inhaled or systemic corticosteroids, whether chronic or acute, within the past 6 months is deemed to adversely affect healing and subjects using such medications are specifically excluded from eligibility.
  • History of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or herpes simplex, 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 a cardiac pacemaker, implanted defibrillator or other implanted electronic device.
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  • History of prior intraocular or corneal surgery (including cataract extraction and/or refractive surgery), existing corneal implant, active ophthalmic disease or abnormality (including, but not limited to, symptomatic blepharitis, recurrent corneal erosion, history or evidence of corneal ulcer (including but not limited to presence of visible corneal scar, abnormal topography is NOT necessary), clinically significant dry eye disease, neovascularization > 1 mm from limbus, retinal detachment/repair, clinically significant lens opacity, clinical evidence of trauma/lesions, corneal opacity within the central 9 mm and visible on topography.
  • Evidence of glaucoma regardless of medication regimen or control, an IOP greater than 21 mmHg at screening or propensity for narrow angle glaucoma.
  • Evidence of keratoconus, pellucid marginal degeneration, corneal dystrophy or irregularity, unstable (distorted/not clear) corneal mires on central keratometry images, corneal edema, corneal lesion, hypotony, or abnormal topography. Corneal thickness thinner than 490 microns at the thinnest point.
  • Known sensitivity or inappropriate responsiveness to any of the medications used in the postoperative course.
  • Either eye does not meet all inclusion criteria and does not fall within approved indications for treatment using femtosecond or excimer Laser.
  • Desire for monovision correction
  • Women who are pregnant, breast-feeding, or intend to become pregnant during the study.
  • Note: Women who were pregnant or nursing may not be enrolled until 6 months after either delivery or have stopped nursing and there is documented refractive stability.
  • Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial
  • Subjects with increased risk of experiencing suction loss during treatment (difficulty achieving or maintaining suction) based on surgeon's determination, such as subjects with: Deep orbits, strong blinks, anxiety, pterygium, difficulty following directions or unable to fixate, head tremor, or any other finding suggesting increased risk of a decentered or malformed lenticule.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Hoopes, Durrie, Rivera Research, LLC

    Draper, Utah, 84020

  • Stanford Eye Laser Center

    Palo Alto, California, 94303

Other trials in United States

About this study

Official title: A PHASED, PROSPECTIVE, MULTI-CENTER STUDY OF THE ELITA SYSTEM FOR THE REDUCTION OR ELIMINATION OF MYOPIC REFRACTIVE ERRORS WITH OR WITHOUT ASTIGMATISM

This study will be a 2-phase, prospective, multicenter, open-label, non-comparative, non-randomized clinical investigation to confirm the safety and effectiveness of the ELITA system.

Being tested
ELITA System
Medical subject headings
Refractive Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ELITA SystemDevice

    Each subject will receive a SILK lenticule removal procedure on one eye and a commercially available laser vision correction procedure on their fellow eye (Feasibility Phase). Subjects will receive a lenticule removal procedure on both eyes to reduce or eliminate myopic refractive errors (Pivotal Phase). The second eye treatment will be considered only after the first eye 1-week follow up visit has been completed and safety criteria are met.

Study groups in NCT05713253
Study groupRoleWhat they receive
ELITA SystemExperimentalEach subject will receive a SILK lenticule removal procedure on one eye and a commercially available laser vision correction procedure on their fellow eye (Feasibility Phase). Subjects will receive a lenticule removal procedure on both eyes to reduce or eliminate myopic refractive errors (Pivotal Phase). The second eye treatment will be considered only after the first eye 1-week follow up visit has been completed and safety criteria are met.
Receives: Device: ELITA System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Monocular UCVA

    The frequency, and proportion of eyes with each acuity line of monocular UCVA

    Measured: 6 months or at the point of refractive stability

  2. Maintenance of BSCVA

    The frequency and proportion of eyes with BSCVA line changes

    Measured: 6 months or at the point of refractive stability

Secondary outcomes (4)

  1. MRSE Predictability

    The frequency and proportion of eyes with MRSE within 0.50 D and 1.00 D. The frequency and proportion of eyes with MRSE under-corrected by more than 1.00 D or 2.00 D and eyes with MRSE over-corrected by more than 1.00 D or 2.00 D.

    Measured: 6 months or at the point of refractive stability

  2. Maintenance of BSCVA-Preservation 20/40

    The frequency and proportion of eyes with each acuity line of BSCVA

    Measured: 6 months or at the point of refractive stability

  3. Induced Manifest Refractive Astigmatism

    The frequency and proportion of eyes with induced manifest refractive astigmatism greater than 2.00 D.

    Measured: 6 months or at the point of refractive stability

  4. Corneal Haze Beyond 6 Months with Loss of > 2 lines of BSCVA

    The frequency and proportion of eyes with corneal haze and loss of ≥ 2 lines of BSCVA beyond 6 months.

    Measured: 9 months or at the point of refractive stability

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2023
  2. Study start2 Feb 2023
  3. Primary completion21 Feb 2025
  4. Study completion21 Feb 2025

Why it stopped: Business decision - not related to safety or device performance

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05713253
Sponsor's protocol ID
CHTA-107-ILEX
Status last verified
Mar 2026
First submitted
25 Jan 2023
Last updated
16 Mar 2026
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

Questions about this trial

What is this clinical trial studying?

A study testing ELITA System in people with 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 15 inclusion and 16 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: stopped early, as of the sponsor's last update on 16 Mar 2026. 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 was stopped early (reason given: Business decision - not related to safety or device performance). Results are not available in the source record.

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?

Monocular UCVA (time frame: 6 months or at the point of refractive stability). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05713253.

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 16 Mar 2026.

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