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Flare Measurements in Human Radiation Therapy Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01640236
Enrollment
10
Registered
2012-07-13
Start date
2012-07-31
Completion date
2014-07-31
Last updated
2014-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The Impact of Whole Body Irradiation on Ocular Flare

Keywords

Ocular flare

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.

Interventions

None listed

Sponsors

University of California, Los Angeles
CollaboratorOTHER
ChromoLogic, LLC
Lead SponsorINDUSTRY

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Ocular flare in radiotherapy patientsDaily 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026