Flare Measurements in Human Radiation Therapy Patients
Completed
- Conditions
- The Impact of Whole Body Irradiation on Ocular Flare
- Registration Number
- NCT01640236
- Lead Sponsor
- ChromoLogic, LLC
- Brief Summary
This is a longitudinal Feasibility Study of a novel non-invasive device in assessing radiation dose exposure in humans. All patients receiving whole body irradiation therapy and meeting all other inclusion/exclusion criteria will receive ocular flare meter measurements and slit-lamp examinations on up to eleven occasions starting prior to the first fractional dose of irradiation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- Subjects must be scheduled to receive whole body irradiation in a dose range from 1.5 to 12Gy.
- Subjects must not have received ocular surgery for at least three months prior to study enrolment.
- Subjects must not have a history of uveitis.
- Subjects must have at least one eye free of cataracts
- Subject age must be greater than 18 years
- Subjects must have the ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria
- Inability to give informed consent
- Cataracts in both eyes
- Subject has received ocular surgery within the prior three months
- Subject has a history of uveitis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ocular flare in radiotherapy patients Daily measurements for the duration of radiotherapy treatment (expected up to four days from start of treatment) Determine if ocular flare meter spectra and/or a slit-lamp eye exam can assess radiation dose exposure in individual human radiotherapy patients.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UCLA Radiation Oncology
🇺🇸Los Angeles, California, United States