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OpenTrials
Completed

NCT Number: NCT06209476

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

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.

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Key information

Conditions

Refractive Error Eye Diseases Refractive Errors

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

VRC

Jacksonville, Florida, 32256, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.
  • 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.

Treatment and study plan

Experimental

Diagnostic 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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Official study title

Clinical Investigation on Assessing the Repeatability and Reproducibility of Central and Peripheral Refractive Error Measurement With the Grand Seiko WAM-5500

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 17, 2024
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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