Characterizing the Intraocular Scattering at Different Wavelengths

Johnson & Johnson Vision Care, Inc.1 个研究点分布在 1 个国家目标入组 31 人开始时间: 2023年5月25日最近更新: 2025年10月14日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Johnson & Johnson Vision Care, Inc.
入组人数: 31
试验地点: 1
主要终点: Point Spread Function (PSF) for 3mm

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Device Feasibility
盲法: None

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•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 ≤2.50 D in each eye.
•The subject must have distance best corrected visual acuity of 20/25 or better in each eye.

排除标准

•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.

研究组 & 干预措施

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

Experimental

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.