Characterizing the Intraocular Scattering at Different Wavelengths

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

Official Title
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Characterizing the Intraocular Scattering at Different Wavelengths

Conditions
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Vision, Ocular

Intervention / Treatment
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* Device: Adaptive Optics System (AO)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Potential subjects must satisfy all the following criteria to be enrolled in the study: Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. Appear able and willing to adhere to the instructions set forth in this clinical protocol. Be at least 18 years of age and not greater than 75 years of age at the time of consent. Has had an eye examination within the last two years. 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. The subject's refractive cylinder must be ≤1.00 D in each eye. 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: Be currently pregnant or lactating. 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). Have any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.). 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. Use of any ocular medication that may interfere with study procedures as determined by the Investigator. Have a history of irregular cornea. Have a history of moderate to severe dry eye. Have Participated in clinical trial within 7 days prior to study enrollment. Be and employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician). Have any contraindications to pupil dilation. Have any known hypersensitivity, allergic reaction or other contraindication to proparacaine, tropicamide, phenylephrine or sodium fluorescein. Have any allergies to dental mold materials or contraindications to having a dental mold made. 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. Have any ocular scars in the central 6 mm of the cornea that may interfere with the study measurement. Have any current ocular infection or inflammation. Intraocular pressure > 21mmHg OD or OS. Ocular angle assessed by Van Herick measurement of grade 2 or less OD or OS.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 770 +/- 9nm/ 830 +/- 15nm/ 900 +/- 15nm<br>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. | Device: Adaptive Optics System (AO)<br>* Subjects will have their higher and lower order aberrations corrected with the AO system.<br>|
| Experimental: 770 +/- 9nm/ 900 +/- 15nm/ 830 +/- 15nm<br>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. | Device: Adaptive Optics System (AO)<br>* Subjects will have their higher and lower order aberrations corrected with the AO system.<br>|
| Experimental: 830 +/- 15nm/ 770 +/- 9nm/ 900 +/- 15nm<br>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. | Device: Adaptive Optics System (AO)<br>* Subjects will have their higher and lower order aberrations corrected with the AO system.<br>|
| Experimental: 830 +/- 15nm/ 900 +/- 15nm/ 770 +/- 9nm<br>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. | Device: Adaptive Optics System (AO)<br>* Subjects will have their higher and lower order aberrations corrected with the AO system.<br>|
| Experimental: 900 +/- 15nm/ 830 +/- 15nm/ 770 +/- 9nm<br>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. | Device: Adaptive Optics System (AO)<br>* Subjects will have their higher and lower order aberrations corrected with the AO system.<br>|
| Experimental: 900 +/- 15nm/ 770 +/- 9nm/ 830 +/- 15nm<br>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. | Device: Adaptive Optics System (AO)<br>* Subjects will have their higher and lower order aberrations corrected with the AO system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point Spread Function (PSF) for 3mm | Point spread function will be collected in one eye at each Visits 2, 3 and 4 for 3mm pupil size for the assigned wavelength at that visit. The PSF is defined as the way an optical system blurs a point source of light. | up to 2-week follow-up | 
| Point Spread Function (PSF) for 4 mm | Point spread function will be collected in one eye at each Visits 2, 3 and 4 for 4mm pupil size for the assigned wavelength at that visit. The PSF is defined as the way an optical system blurs a point source of light. | up to 2-week follow-up | 
| Point Spread Function (PSF) for 6 mm | Point spread function will be collected in one eye at each Visits 2, 3 and 4 for 6mm pupil size for the assigned wavelength at that visit. The PSF is defined as the way an optical system blurs a point source of light. | up to 2-week follow-up |