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

Refractive Error Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06209476
• Other study ID #: CR-6559
• Status: Completed
• Start date: January 16, 2024
• Est. completion date: February 5, 2024

Study information

• Verified date: February 2024
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 5, 2024
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Diagnostic Test:
• Experimental
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.

Locations

Country	Name	City	State
United States	VRC	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 10-day follow-up visit
Primary	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.	Up to 10-day follow-up visit
Primary	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.	Up to 10-day follow-up visit
Primary	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.	Up to 10-day follow-up visit
Primary	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.	Up to 10-day follow-up visit
Primary	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.	Up to 10-day follow-up visit
Primary	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.	Up to 10-day follow-up visit