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Clinical Trials/NCT01640236
NCT01640236
Completed
Not Applicable

Flare Measurements in Human Radiation Therapy Patients

ChromoLogic, LLC1 site in 1 country10 target enrollmentJuly 2012

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.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
July 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Study Sites (1)

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