Flare Measurements in Human Radiation Therapy Patients

ChromoLogic

Status: Completed

Conditions: The Impact of Whole Body Irradiation on Ocular Flare

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01640236

OCDOS_PRO_110314_02

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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