Refractive ErrorNCT06209476
Clinical Investigation on Assessing the Repeatability and Reproducibility of Central and Peripheral Refractive Error
An observational study of Refractive Error, run by Johnson & Johnson Vision Care, Inc. at 1 site in United States.
Trial summary
This is a unilateral, non-interventional study. Each subject will be unilaterally measured with the WAM-5500 autorefractor by 3 testers. All measurements will be made on the right eye only. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Error
- What is being tested?
- Experimental
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2024to 5 Feb 2024
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy male and female subjects between 18 and 50 years of age (inclusive) of any ethnicity with sphere component of the subjective spherocylindrical refraction between +1.50 to -6.00D (inclusive) and 2.00D or less astigmatism in the right eye.
Who may be able to join
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- Read, understand, and sign the STATEMENT OF INFORMED CONSENT 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 between 18 and 50 (inclusive) years of age at the time of screening.
- The spherical component of the subject's non-vertex-corrected distance subjective refraction must be between +1.50 and -6.00DS (inclusive), with the magnitude of the cylinder 2.00 DC or less in the right eye.
- The subject must have a Van Herrick angle grade of at least 3 or greater in the right eye.
- The subject must have a BSCVA of at least 20/30 (defined as reading at least 3 out of the 5 letters on the 20/30 line) in the right eye.
Who cannot join
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Be currently pregnant or lactating.
- Be diabetic or pre-diabetic by self-report.
- Have a history of ocular trauma, systemic disease or medication use known to cause variability in refractive error.
- 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.).
- Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, scleral lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 3 months.
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- Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
- Take ocular and systemic medications known to interact with Tropicamide ophthalmic solution or systemic medications that can cause myopia.
- Have a history of an allergic reaction to Tropicamide or Proparacaine.
- 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 that may compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, corneal scar or opacity ≥ 0.3 mm, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
- Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
- Have a history of strabismus, amblyopia, nystagmus, or any condition that affects fixation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Investigation on Assessing the Repeatability and Reproducibility of Central and Peripheral Refractive Error Measurement With the Grand Seiko WAM-5500
This is a unilateral, non-interventional study. Each subject will be unilaterally measured with the WAM-5500 autorefractor by 3 testers. All measurements will be made on the right eye only.
- Conditions
- Refractive Error
- Being tested
- Experimental
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalDiagnostic test
Eligible subjects with sphere component of the subjective spherocylindrical refraction between +1.50 to -6.00D (inclusive) and 2.00D or less astigmatism in the right eye will be unilaterally measured with the WAM-5500 autorefractor by 3 testers.
What is being measured
The primary outcome is the main question the study is designed to answer.
Central (on-axis) cycloplegic auto-refraction
Central (on-axis) cycloplegic auto-refraction will be measured to evaluate the intra-visit repeatability, inter-visit repeatability, and reproducibility of central refractive error measurements with the Grand Seiko WAM-5500.
Measured: Up to 10-day follow-up visit
Peripheral (10° off-axis on the temporal retina) cycloplegic auto-refraction
Peripheral cycloplegic auto-refraction will be measured to evaluate the intra-visit repeatability, inter-visit repeatability, and reproducibility of peripheral refractive error measurements with the Grand Seiko WAM-5500 at 10° temporal retina.
Measured: Up to 10-day follow-up visit
Peripheral (20° off-axis on the temporal retina) cycloplegic auto-refraction
Peripheral cycloplegic auto-refraction will be measured to evaluate the intra-visit repeatability, inter-visit repeatability, and reproducibility of peripheral refractive error measurements with the Grand Seiko WAM-5500 at 20° temporal retina.
Measured: Up to 10-day follow-up visit
Peripheral (30° off-axis on the temporal retina) cycloplegic auto-refraction
Peripheral cycloplegic auto-refraction will be measured to evaluate the intra-visit repeatability, inter-visit repeatability, and reproducibility of peripheral refractive error measurements with the Grand Seiko WAM-5500 at 30° temporal retina.
Measured: Up to 10-day follow-up visit
Peripheral (10° off-axis on the nasal retina) cycloplegic auto-refraction
Peripheral cycloplegic auto-refraction will be measured to evaluate the intra-visit repeatability, inter-visit repeatability, and reproducibility of peripheral refractive error measurements with the Grand Seiko WAM-5500 at 10° nasal retina.
Measured: Up to 10-day follow-up visit
Peripheral (20° off-axis on the nasal retina) cycloplegic auto-refraction:
Peripheral cycloplegic auto-refraction will be measured to evaluate the intra-visit repeatability, inter-visit repeatability, and reproducibility of peripheral refractive error measurements with the Grand Seiko WAM-5500 at 20° nasal retina.
Measured: Up to 10-day follow-up visit
Peripheral (30° off-axis on the nasal retina) cycloplegic auto-refraction
Peripheral cycloplegic auto-refraction will be measured to evaluate the intra-visit repeatability, inter-visit repeatability, and reproducibility of peripheral refractive error measurements with the Grand Seiko WAM-5500 at 30° nasal retina.
Measured: Up to 10-day follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start16 Jan 2024
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 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
- NCT06209476
- Sponsor's protocol ID
- CR-6559
- Status last verified
- Apr 2025
- First submitted
- 8 Jan 2024
- Last updated
- 25 Apr 2025
- Results posted
- 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