MyopiaNCT06075576
Characterization of the Central and Peripheral Wavefront Aberration Profile in Pediatric Myopic Subjects
An observational study of Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site in United States.
Trial summary
This is a 3-visit, single site, observational clinical study to evaluate the characterization of the central and peripheral wavefront aberration profiles in pediatric myopic subjects. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Intervention
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2023to 11 Aug 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy male and female non-contact lens wearing subjects within ages 6 to 17 years will be recruited. Subjects enrolled in this study will be myopic. Approximately half the number of subjects will be under 10 years of age.
Who may be able to join
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- The subject must:
- Read or (be read to) and sign the CHILDREN'S ASSENT (information and assessment form) and receive a fully executed copy of the form.
- Have parents or legal guardians who must read, understand, and sign the STATEMENT OF INFORMED CONSENT FORM and receive a fully executed copy of the form.
- Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Be at least 6 years of age and not greater than 17 years of age at the time of consent.
Show all 9Show fewer
- The subjects are required to be within -1.00 to -6.00 D (inclusive) for the spherical component of vertex- corrected refraction.
- The magnitude of cylindrical component of the subject's vertex distance corrected distance refraction must be between 0.00 and 2.25 D in each eye.
- The subject must have distance best corrected visual acuity of 20/25 or better in each eye.
Who cannot join
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- The subject must not:
- Be currently pregnant or lactating.
- Be diabetic.
- Be currently using any ocular medications or have any ocular infection of any type.
- By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that may otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g., rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications.
Show all 21Show fewer
- Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months.
- History of pharmacologic treatment for myopia within the past 2 years.
- Have participated in any study using pharmacologic agents within 30 days prior to study enrollment.
- Use of any ocular medication, except for rewetting drops.
- Have a history of pathological dry eye.
- Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
- Have any known hypersensitivity or allergic reaction to rewetting drop solutions, topical anesthetic (Proparacaine), topical cycloplegic drops (Tropicamide) or sodium fluorescein.
- Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
- Have a history of strabismus or amblyopia.
- Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
- Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).
- Intraocular pressure >21 mm of Hg OD or OS.
- Ocular anterior chamber angle assessed by Van Herick's measurement of grade 2 or less OD or OS.
- Have latent, manifest nystagmus or any fixation related abnormality (at the discretion of the investigator).
- Have any corneal scar and/or distortion within the central 6 mm.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Houston College of Optometry - J. Armistead Bldg Room 2195
Houston, Texas, 77204
About this study
This is a 3-visit, single site, observational clinical study to evaluate the characterization of the central and peripheral wavefront aberration profiles in pediatric myopic subjects.
- Conditions
- Myopia
- Being tested
- Intervention
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionDiagnostic test
No test articles will be used in the study. However, while taking measurements, the subject's eye will be exposed to light or light flashes that are about the same or lesser intensity than those in a routine eye exam in an eye care provider's office.
What is being measured
The primary outcome is the main question the study is designed to answer.
Central aberration profile of pediatric myopia population under cycloplegic conditions for distance
Assessment of central aberration profile of pediatric myopia population under cycloplegic conditions for distance (target at 4m) viewing conditions.
Measured: up to day 26 from Visit 1
Peripheral aberration profile of pediatric myopia population under cycloplegic conditions for distance
Assessment of peripheral aberration profile of pediatric myopia population under cycloplegic conditions for distance (target at 4m) viewing conditions.
Measured: up to day 26 from Visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start16 Nov 2023
- Primary completion11 Aug 2025
- Study completion11 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Vision Care, Inc. Clinical Trial, Study director, Johnson & Johnson Vision Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075576
- Sponsor's protocol ID
- CR-6526
- Status last verified
- Dec 2025
- First submitted
- 4 Oct 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) 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 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Central and Peripheral Wavefront Aberration Profile in Pediatric Myopic Subjects
- ClinicalTrials.gov ID
- NCT06075576
- Acronym / sponsor ID
- CR-6526
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 11 Aug 2025 (actual)
- Study completion
- 11 Aug 2025 (actual)
- First posted
- 10 Oct 2023 (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.
This is a 3-visit, single site, observational clinical study to evaluate the characterization of the central and peripheral wavefront aberration profiles in pediatric myopic subjects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy male and female non-contact lens wearing subjects within ages 6 to 17 years will be recruited. Subjects enrolled in this study will be myopic. Approximately half the number of subjects will be under 10 years of age.
Key inclusion criteria (9 listed)
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- Read or (be read to) and sign the CHILDREN'S ASSENT (information and assessment form) and receive a fully executed copy of the form.
- Have parents or legal guardians who must read, understand, and sign the STATEMENT OF INFORMED CONSENT FORM and receive a fully executed copy of the form.
- Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Be at least 6 years of age and not greater than 17 years of age at the time of consent.
Key exclusion criteria (21 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Be currently pregnant or lactating.
- Be diabetic.
- Be currently using any ocular medications or have any ocular infection of any type.
- By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that may otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g., rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications.
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 |
|---|---|---|
| InterventionNo test articles will be used in the study. However, while taking measurements, the subject's eye will be exposed to light or light flashes that are about the same or lesser intensity than those in a routine eye exam in an eye care provider's office. | Diagnostic test | – |
Primary outcome
Central aberration profile of pediatric myopia population under cycloplegic conditions for distance
Time frame: up to day 26 from Visit 1
Assessment of central aberration profile of pediatric myopia population under cycloplegic conditions for distance (target at 4m) viewing conditions.
Peripheral aberration profile of pediatric myopia population under cycloplegic conditions for distance
Time frame: up to day 26 from Visit 1
Assessment of peripheral aberration profile of pediatric myopia population under cycloplegic conditions for distance (target at 4m) viewing conditions.
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 24 Dec 2025.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) 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
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
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.
Johnson & Johnson Vision Care, Inc. Clinical Trial study director
Johnson & Johnson Vision Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Johnson & Johnson Vision Care, Inc. at 1 site 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 9 inclusion and 21 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 24 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 1 site 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?
Central aberration profile of pediatric myopia population under cycloplegic conditions for distance (time frame: up to day 26 from Visit 1). 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?
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 24 Dec 2025.