To assess ophthalmic health in parallel cohorts of patients with breast cancer
This is a multicentre study assessing the ophthalmic safety in patients who are participating in a qualifying study. The study will include two cohorts of at least 60 individuals each. To be able to account for events associated with aging, worsening of pre-existing conditions, etc., ophthalmic study assessments will be performed in parallel in two cohorts at the same timepoints. The duration of the study assessment period will be approximately 12 months. Longer duration of the study would result in additional patient burden.
Study Type
OBSERVATIONAL
Enrollment
160
Visual Acuity Testing (Snellen units)
To detect potential impairment in central vision in patients with breast cancer.
Time frame: Ophthalmic review by central reader until 28 days after End of Study visit.
Slit Lamp examination (normal/abnormal)
To detect any corneal changes or lens changes (eg, cataracts) that could impact high and low contrast acuity/visual field in patients with breast cancer.
Time frame: Ophthalmic review by local ophthalmologist until 28 days after End of Study visit.
Optical Coherence Tonometry (μm)
To assess any structural change/damage to the eye or any long-term visual effects in patients with breast cancer.
Time frame: Ophthalmic review by central reader until 28 days after End of Study visit.
Fundus Examination (normal/abnormal)
To assess any structural change/damage to the eye or any long-term visual effects in patients with breast cancer.
Time frame: Ophthalmic review by central reader until 28 days after End of Study visit.
Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0)
To assess the ophthalmic safety in patients with breast cancer.
Time frame: Until 28 days after the End of Study visit
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Research Site
La Jolla, California, United States
Research Site
Palo Alto, California, United States
Research Site
Iowa City, Iowa, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Clairton, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Sioux Falls, South Dakota, United States
Research Site
Bartlett, Tennessee, United States
Research Site
Houston, Texas, United States
Research Site
CABA, Argentina
...and 40 more locations