Retinal Oxygen Function After Radiation Therapy

Completed

• Conditions: A History of Radiation Therapy for a Tumor in the Vicinity of the Retina(s)

• Registration Number: NCT02043470
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Primary Completion: 2015-07
• Status Verified: 2017-05
• Study Completion: 2017-05-04
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. ≥ 18 years of age at the time of radiation therapy (no upper age limit)
2. History of radiation therapy delivered at UNC-CH or Rex Hospital to the vicinity of the retina(s) ≥ 2 months prior to enrollment
3. Estimated average dose to at least one quadrant of one retina ≥ 30 Gy

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of vision loss in patients with previous incidental irradiation of the retina	2 months	To determine the prevalence of regional retinal dysfunction (i.e. vision loss) in patients with previous incidental irradiation of the retina.
Abnormalities in regional retinal oxygen extraction after incidental irradiation of the retina.	2 months	To identify abnormalities in regional retinal oxygen extraction in patients who have had previous incidental irradiation of the retina.

Secondary Outcome Measures

Name	Time	Method
Vision loss amount versus radiation dose.	2 months	To correlate retinal dysfunction (i.e. vision loss) to radiation dose.
Changes in retinal oxygen extraction as compared to vision loss.	2 months	To correlate changes in retinal oxygen extraction to retinal dysfunction (i.e. vision loss).
Changes in retinal oxygen extraction compared to radiation dose	2 months	To correlate changes in retinal oxygen extraction to radiation dose.

Trial Locations

Locations (1)

Department of Radiation Oncology Clinic; 🇺🇸 Chapel Hill, North Carolina, United States