Clinical trial NCT06209476: Clinical Investigation on Assessing the Repeatability and Reproducibility of Central and Peripheral Refractive Error
Official title: Clinical Investigation on Assessing the Repeatability and Reproducibility of Central and Peripheral Refractive Error Measurement With the Grand Seiko WAM-5500
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractive Error
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Central (on-axis) cycloplegic auto-refraction
timeFrame: Up to 10-day follow-up visit
measure: Peripheral (10° off-axis on the temporal retina) cycloplegic auto-refraction
timeFrame: Up to 10-day follow-up visit
measure: Peripheral (20° off-axis on the temporal retina) cycloplegic auto-refraction
timeFrame: Up to 10-day follow-up visit
measure: Peripheral (30° off-axis on the temporal retina) cycloplegic auto-refraction
timeFrame: Up to 10-day follow-up visit
measure: Peripheral (10° off-axis on the nasal retina) cycloplegic auto-refraction
timeFrame: Up to 10-day follow-up visit
measure: Peripheral (20° off-axis on the nasal retina) cycloplegic auto-refraction:
timeFrame: Up to 10-day follow-up visit
measure: Peripheral (30° off-axis on the nasal retina) cycloplegic auto-refraction
timeFrame: Up to 10-day follow-up visit
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: VRC
state: Florida
Study officials:
affiliation: Johnson & Johnson Vision Care, Inc.
name: Johnson & Johnson Vision Care, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: