Skip to main content
OpenTrials
Completed

NCT Number: NCT02043470

Retinal Oxygen Function After Radiation Therapy

The investigators propose using retinal oximetry to assess for abnormalities in regional retinal oxygen consumption in previously- irradiated patients, and relate these abnormalities to changes in regional retinal function (i.e. visual field abnormalities). Since different regions of retina receive different radiation doses, the investigators will assess for a dose response as well.

Completed

Looking for future studies?

Notify Me

Key information

About this study

Radiation therapy (RT) is a common treatment for patients with cancers of the sinonasal area, orbit, skull base, nasopharynx, and brain. Because of the close proximity of these targets to the eyes, the retina is often incidentally and unavoidably irradiated. As a result, some patients develop radiation retinopathy and possibly vision loss. Clinicopathologic studies suggest similar microvascular mechanisms for both radiation- and diabetic retinopathy: small vessel occlusion and ischemia that can lead to neovascularization, increased capillary permeability, and visual loss in the regions of retina perfused by damaged vasculature. UNC has a novel, non-invasive retinal imaging technology called a Retinal Oximeter which measures hemoglobin oxygen saturation of retinal vessels. The difference in oxygen saturation between a retinal arteriole and venule pair reflects the oxygen consumption of the retinal region supplied by that vessel pair.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years of age at the time of radiation therapy (no upper age limit)
  • History of radiation therapy delivered at UNC-CH or Rex Hospital to the vicinity of the retina(s) ≥ 2 months prior to enrollment
  • Estimated average dose to at least one quadrant of one retina ≥ 30 Gy

Exclusion criteria

  • History of diabetes, retinal vascular occlusions, glaucoma, retinitis pigmentosa, occipital stroke or any other ophthalmologic or systemic problem that may confound visual field results.
  • Residual tumor within the visual pathway: retina, optic nerves, optic chiasm, optic radiations and brain.

Treatment and study plan

Primary outcomes

  1. Abnormalities in regional retinal oxygen extraction after incidental irradiation of the retina.

    Time frame: 2 months

    To identify abnormalities in regional retinal oxygen extraction in patients who have had previous incidental irradiation of the retina.

  2. Prevalence of vision loss in patients with previous incidental irradiation of the retina

    Time frame: 2 months

    To determine the prevalence of regional retinal dysfunction (i.e. vision loss) in patients with previous incidental irradiation of the retina.

Secondary outcomes

  1. Changes in retinal oxygen extraction compared to radiation dose

    Time frame: 2 months

    To correlate changes in retinal oxygen extraction to radiation dose.

  2. Vision loss amount versus radiation dose.

    Time frame: 2 months

    To correlate retinal dysfunction (i.e. vision loss) to radiation dose.

  3. Changes in retinal oxygen extraction as compared to vision loss.

    Time frame: 2 months

    To correlate changes in retinal oxygen extraction to retinal dysfunction (i.e. vision loss).

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • UNC Translational and Clinical Sciences (Tracs)

Registry information

Official study title

Changes in Regional Retinal Oxygen Extraction and Function After Radiation Therapy

Important dates

Study start
2011
Primary completion
2015
Study completion
2017
First posted
Jan 23, 2014
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.