Clinical Investigation on Assessing the Repeatability and Reproducibility of Central and Peripheral Refractive Error

April 24, 2025 updated by: Johnson & Johnson Vision Care, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32256
        • VRC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Be between 18 and 50 (inclusive) years of age at the time of screening.
  4. 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.
  5. The subject must have a Van Herrick angle grade of at least 3 or greater in the right eye.
  6. 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.

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Be currently pregnant or lactating.
  2. Be diabetic or pre-diabetic by self-report.
  3. Have a history of ocular trauma, systemic disease or medication use known to cause variability in refractive error.
  4. 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.).
  5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, scleral lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 3 months.
  6. 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.
  7. Take ocular and systemic medications known to interact with Tropicamide ophthalmic solution or systemic medications that can cause myopia.
  8. Have a history of an allergic reaction to Tropicamide or Proparacaine.
  9. 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).
  10. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
  11. Have a history of strabismus, amblyopia, nystagmus, or any condition that affects fixation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Central (on-axis) cycloplegic auto-refraction
Time Frame: Up to 10-day follow-up visit
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.
Up to 10-day follow-up visit
Peripheral (10° off-axis on the temporal retina) cycloplegic auto-refraction
Time Frame: Up to 10-day follow-up visit
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.
Up to 10-day follow-up visit
Peripheral (20° off-axis on the temporal retina) cycloplegic auto-refraction
Time Frame: Up to 10-day follow-up visit
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.
Up to 10-day follow-up visit
Peripheral (30° off-axis on the temporal retina) cycloplegic auto-refraction
Time Frame: Up to 10-day follow-up visit
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.
Up to 10-day follow-up visit
Peripheral (10° off-axis on the nasal retina) cycloplegic auto-refraction
Time Frame: Up to 10-day follow-up visit
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.
Up to 10-day follow-up visit
Peripheral (20° off-axis on the nasal retina) cycloplegic auto-refraction:
Time Frame: Up to 10-day follow-up visit
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.
Up to 10-day follow-up visit
Peripheral (30° off-axis on the nasal retina) cycloplegic auto-refraction
Time Frame: Up to 10-day follow-up visit
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.
Up to 10-day follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Vision Care, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Johnson & Johnson Vision Care, Inc. Clinical Trial, Johnson & Johnson Vision Care, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 5, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR-6559

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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