Characterizing the Intraocular Scattering at Different Wavelengths

NCT ID: NCT05602623

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-25
• Study Completion Date: 2024-06-12

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.

Conditions

Vision, Ocular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Adaptive Optics System (AO)

Intervention Type: DEVICE

Subjects will have their higher and lower order aberrations corrected with the AO system.

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

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.

Group Type: EXPERIMENTAL

Adaptive Optics System (AO)

Intervention Type: DEVICE

Subjects will have their higher and lower order aberrations corrected with the AO system.

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

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.

Group Type: EXPERIMENTAL

Adaptive Optics System (AO)

Intervention Type: DEVICE

Subjects will have their higher and lower order aberrations corrected with the AO system.

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

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.

Group Type: EXPERIMENTAL

Adaptive Optics System (AO)

Intervention Type: DEVICE

Subjects will have their higher and lower order aberrations corrected with the AO system.

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

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.

Group Type: EXPERIMENTAL

Adaptive Optics System (AO)

Intervention Type: DEVICE

Subjects will have their higher and lower order aberrations corrected with the AO system.

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

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.

Group Type: EXPERIMENTAL

Adaptive Optics System (AO)

Intervention Type: DEVICE

Subjects will have their higher and lower order aberrations corrected with the AO system.

Interventions

Adaptive Optics System (AO)

Subjects will have their higher and lower order aberrations corrected with the AO system.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Vision Care Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Vision Care

Locations

University of Houston College of Optometry

Houston, Texas, United States

Countries

United States

Other Identifiers

CR-6476

Identifier Type: -

Identifier Source: org_study_id