Flare Measurements in Human Radiation Therapy Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- The Impact of Whole Body Irradiation on Ocular Flare
- Sponsor
- ChromoLogic, LLC
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Ocular flare in radiotherapy patients
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Ocular flare in radiotherapy patients
Time Frame: 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.