Subject Population. The study population includes approximately 36 volunteer subjects to be enrolled at approximately 2 sites, with approximately 18-36 subjects enrolled per site. The study population will consist of subjects with normal eyes (other than the need for optical correction for refractive ametropia) and who are adapted, existing wearers of soft contact lenses in both eyes. Subjects must be screened according to the full list of inclusion/exclusion criteria in Section 1 of this protocol. Rescreening of subjects after screen failure is not allowed in this study.
Subject Population. The study population includes approximately 36 volunteer subjects to be enrolled at approximately 3 sites, with approximately 12 subjects enrolled per site. To account for potential screening failure and early discontinuation, approximately 36 subjects are expected to be enrolled to obtain a target of 32 completed subjects. Subjects must be screened according to the full list of inclusion/exclusion criteria in Section 1 of this protocol. The study population will consist of subjects with normal eyes who are adapted, existing wearers of weekly/monthly soft contact lenses in both eyes, and require contact lens sphere power from -1.00 to -6.00 D. Rescreening of subjects is allowed only for the following criteria and under the following conditions: • INC01 – subject must be at least 18 years of age • EXC13 – participation in a clinical trial within the previous 7 days or currently enrolled in another clinical trial • A protocol amendment potentially changes eligibility of previously screened and excluded subjects A subject may only be rescreened once and rescreening should take place within one week of the original screening date.
Subject Population. The study population includes approximately 160 subjects to be bilaterally implanted at approximately 15 sites with approximately 10 subjects per site. Enrollment is anticipated to take approximately 6 months. To participate in the clinical trial, subjects must be ≥ 22 years of age with no ocular pathology that could confound study outcomes, must require clear cornea cataract extraction in both eyes, and must desire an IOL that provides the potential for near, intermediate and distance vision. Additional entry criteria are listed below in Sections 10.1 through 10.3. Check all entry criteria at baseline (Visit 0) and at both surgical visits (Visit 00, Visit 00A). If a subject is excluded post randomization and prior to 1st eye surgery (IOL does not come in contact with the eye), the subject should be discontinued from participation in the study.
Subject Population. Subjects may discontinue study participation at any time and for any reason. Subjects may be discontinued from the study at any time if in the medical opinion of the PI or designated, qualified medical personnel, continued participation poses a health risk to the subject. Subject numbers from discontinued subjects will not be reissued. Discontinued subjects will not be replaced.
Subject Population. Number of Subjects Inclusion Criteria For All Subjects: A subject must meet ALL of the following criteria to be eligible for enrollment in this study:
Subject Population. Provide a detailed description of the types of human subjects who will be recruited into this study. XXXx—12 Black church members and leaders who are well versed in the practices of the Black church will be recruited by Rev Streets to serve in this role.
Subject Population. The study population includes approximately 36 volunteer subjects to be enrolled at approximately 4 sites, with approximately 9 subjects enrolled per site. The study population will consist of subjects aged 18 or over with normal eyes (other than the need for optical correction for myopia), who are adapted, existing wearers of weekly/monthly soft contact lenses in both eyes and positive for dryness symptoms with their habitual contact lenses Subjects may be pre-screened for dryness symptoms and must be screened according to the full list of inclusion/exclusion criteria in Section 1 of this protocol. Rescreening of subjects is not allowed in this study.
Subject Population. The ATS Plan addresses services to the most acutely disadvantaged and fragile communities, seniors and persons with disabilities. These populations are typically also low income.
Subject Population. Provide a detailed description of the proposed involvement of human subjects. Describe the characteristics of the subject population, including their anticipated number, age range and health status. Any male or female >18yo who require surgery involving tissue flaps. The selection of subjects should be equitable. Generally speaking, the subject selection should reflect a reasonable cross-section of the population that is being studied. In research that requires a more restricted population, the rationale for this need should be fully justified. Investigators must also provide scientific justification for the exclusion of underrepresented populations such as women, children, or minorities.
Subject Population. The study population includes approximately 60 volunteer subjects to be enrolled at approximately 4 sites, with approximately 15 subjects enrolled per site. Subjects must be screened according to the full list of inclusion/exclusion criteria in Section 1 of this protocol. Rescreening of subjects is not allowed in this study.
