Characterizing the Intraocular Scattering at Different Wavelengths

Johnson & Johnson (J&J)

Status: Completed

Conditions: Vision, Ocular

Treatments: Device: Adaptive Optics System (AO)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05602623

CR-6476

Details and patient eligibility

About

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

Enrollment: 31 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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31 participants in 6 patient groups

770 +/- 9nm/ 830 +/- 15nm/ 900 +/- 15nm

Experimental group

Description:

Eligible subjects will be randomized to wavelength sequence 770 +/- 9nm/ 830 +/- 15nm/ 900 +/- 15nm. Within each wavelength, subjects will be further randomized to a pupil size sequence (3mm, 4mm, 6mm). Study endpoints will be measured at 3 different pupil sizes.

Treatment:

Device: Adaptive Optics System (AO)

770 +/- 9nm/ 900 +/- 15nm/ 830 +/- 15nm

Experimental group

Description:

Eligible subjects will be randomized to wavelength sequence 770 +/- 9nm/ 900 +/- 15nm/ 830 +/- 15nm. Within each wavelength, subjects will be further randomized to a pupil size sequence (3mm, 4mm, 6mm). Study endpoints will be measured at 3 different pupil sizes.

Treatment:

Device: Adaptive Optics System (AO)

830 +/- 15nm/ 770 +/- 9nm/ 900 +/- 15nm

Experimental group

Description:

Eligible subjects will be randomized to wavelength sequence 830 +/- 15nm/ 770 +/- 9nm/ 900 +/- 15nm. Within each wavelength, subjects will be further randomized to a pupil size sequence (3mm, 4mm, 6mm). Study endpoints will be measured at 3 different pupil sizes.

Treatment:

Device: Adaptive Optics System (AO)

830 +/- 15nm/ 900 +/- 15nm/ 770 +/- 9nm

Experimental group

Description:

Eligible subjects will be randomized to wavelength sequence 830 +/- 15nm/ 900 +/- 15nm/ 770 +/- 9nm. Within each wavelength, subjects will be further randomized to a pupil size sequence (3mm, 4mm, 6mm). Study endpoints will be measured at 3 different pupil sizes.

Treatment:

Device: Adaptive Optics System (AO)

900 +/- 15nm/ 830 +/- 15nm/ 770 +/- 9nm

Experimental group

Description:

Eligible subjects will be randomized to wavelength sequence 900 +/- 15nm/ 830 +/- 15nm/ 770 +/- 9nm. Within each wavelength, subjects will be further randomized to a pupil size sequence (3mm, 4mm, 6mm). Study endpoints will be measured at 3 different pupil sizes.

Treatment:

Device: Adaptive Optics System (AO)

900 +/- 15nm/ 770 +/- 9nm/ 830 +/- 15nm

Experimental group

Description:

Eligible subjects will be randomized to wavelength sequence 900 +/- 15nm/ 770 +/- 9nm/ 830 +/- 15nm. Within each wavelength, subjects will be further randomized to a pupil size sequence (3mm, 4mm, 6mm). Study endpoints will be measured at 3 different pupil sizes.

Treatment:

Device: Adaptive Optics System (AO)