Clinical trial NCT05602623: Characterizing the Intraocular Scattering at Different Wavelengths
Official title: Characterizing the Intraocular Scattering at Different Wavelengths
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vision, Ocular
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is a single-site, unmasked, 4-visit, randomized 3x3 cross-over clinical trial to quantify intraocular light scatter in different age groups.


Eligibility criteria: Inclusion Criteria:

Potential subjects must satisfy all 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 at least 18 years of age and not greater than 75 years of age at the time of consent.
4. Has had an eye examination within the last two years.
5. The subject's distance vertex corrected spherical equivalent refraction must be in the range of +4.00 D to -6.00 D in each eye.
6. The subject's refractive cylinder must be ≤2.50 D in each eye.
7. The subject must have distance best corrected visual acuity of 20/25 or better in each 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. Have any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with their ocular health. This may include, but not be limited to, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g., hepatitis, tuberculosis).
3. Have any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
4. Use of any of the following medications within 1 week prior to enrollment: oral retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral/inhaled corticosteroids, monoamine oxide inhibitors. See Section 9.1 for further examples.
5. Use of any ocular medication that may interfere with study procedures as determined by the Investigator.
6. Have a history of irregular cornea.
7. Have a history of moderate to severe dry eye.
8. Have Participated in clinical trial within 7 days prior to study enrollment.
9. Be and employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
10. Have any contraindications to pupil dilation.
11. Have any known hypersensitivity, allergic reaction or other contraindication to proparacaine, tropicamide, phenylephrine or sodium fluorescein.
12. Have any allergies to dental mold materials or contraindications to having a dental mold made.
13. Have clinically significant (Grade 3 or greater) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities that may interfere with the study measurements.
14. Have any ocular scars in the central 6 mm of the cornea that may interfere with the study measurement.
15. Have any current ocular infection or inflammation.
16. Intraocular pressure \> 21mmHg OD or OS.
17. Ocular angle assessed by Van Herick measurement of grade 2 or less OD or OS.

Primary outcomes:
measure: Point Spread Function (PSF) for 3mm
timeFrame: up to 2-week follow-up
measure: Point Spread Function (PSF) for 4 mm
timeFrame: up to 2-week follow-up
measure: Point Spread Function (PSF) for 6 mm
timeFrame: up to 2-week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston College of Optometry
state: Texas
Study officials:
affiliation: Johnson & Johnson Vision Care
name: Johnson & Johnson Vision Care Clinical Trial
role: STUDY_DIRECTOR
References: