Optical Coherence Tomography Angiography Characteristics of Radiation Optic Neuropathy

Aim: To develop a suitable radiation optic neuropathy (RON) diagnostic model based on optical coherence tomography angiography (OCTA) and to reveal the correlation between endocrine and OCTA indexes in nasopharyngeal carcinoma (NPC) patients with radiation encephalopathy (RE).

Methods: This retrospective cross-sectional study included 80 male NPC patients with RE following radiotherapy (40 non-RON and 40RON). Endocrine and OCTA indexes were collected. The macular and peripapillary vessel density (VD) were automatically analyzed using AngioVue 2.0 of the RTVue XR Avanti device. The OCTA indexes were included in the multivariable binary logistic regression model between non-RON and RON. For all RE patients, a multiple linear regression was performed between each of the OCTA indexes and the endocrine indexes.

Study Overview

• Status: Completed
• Conditions: Optic Radiation Neuropathy Following Radiotherapy Procedure
• Intervention / Treatment: Radiation: head and neck radiation

Detailed Description

Best corrected visual acuity (BCVA) and OCTA (Optovue, Inc., CA, USA) were performed in the RE patients. All examinations were performed by experienced ophthalmic examiners. AngioVue software 2.0 of the RTVue XR Avanti device (Optovue, Inc., CA, USA) was used to perform OCTA imaging. The split-spectrum amplitude-decorrelation angiography (SSADA) algorithm was applied to the scans. Images with a scan quality of not less than 6 were included, while images with obvious artifacts detected by a senior ophthalmologist were excluded. The vessel density (VD) and retinal thickness of the macular and optic nerve head (ONH) area were automatically analyzed in 6 × 6 mm angioretina mode and 4.5 × 4.5 mm angiodisc mode, respectively.

The statistical analyzes were performed using SPSS 24.0 (SPSS Inc., IL, USA). Student's t-test was performed to compare normally distributed variables, while the Mann-Whitney test was performed to compare nonnormally distributed variables. Categorical variables were analyzed with the chi-squared test Statistical significance was set at p < 0.05. The major statistically significant OCTA variables were included in the multivariable binary logistic regression model between NRON and RON. Then, thereceiver operating characteristic (ROC) curve was generated according to the model, and the area under the curve (AUC), sensitivity (SE) and specificity (SP) were reported. In addition, for all RE patients, backward multiple linear regression was performed between each of the above OCTA variables and the statistically significant endocrine indexes.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • Zijing Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The diagnosis of RON was established according to the following criteria: (1) painless progressive sight loss, (2) abnormal VEP and VF defect, and/or (3) ophthalmoscopic evidence of blurring of the optic disc margins, dilation of retinal veins, hemorrhages, exudates, neovascularization or atrophic optic disc, and/or (4) impaired optic nerve based on MRI.

Description

Inclusion Criteria:

(1) Paitients were diagnosed as radiation encephalopathy (RE) confirmed by a neurologist based on magnetic resonance imaging (MRI). The RE patients were divided into RON and non-RON (NRON) groups.

(2）The diagnosis of RON was established according to the following criteria: 1) painless progressive sight loss, 2) abnormal VEP and VF defect, and/or 3) ophthalmoscopic evidence of blurring of the optic disc margins, dilation of retinal veins, hemorrhages, exudates, neovascularization or atrophic optic disc, and/or 4) impaired optic nerve based on MRI.

Exclusion Criteria:

1. other diseases that may cause sight loss, such as stroke, glaucoma, optic neuritis, ischemic optic neuropathy and other optic neuropathy and retinal diseases;
2. NPC recurrence or metastase;
3. uncontrollable diabetes mellitus, hypertension and other serious systemic diseases;
4. lens opacity that affected imaging;
5. an axial length of the included eye greater than 26 mm or a spherical equivalent outside the range between + 3.0 and -3.0 diopters, and
6. a history of intraocular surgery.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal
RON	Radiation: head and neck radiation; RON and non-RON: nasopharyngeal carcinoma patients recieved head and neck radiation; Normal: normal individuals.
non-RON; non-RON but with radiiation treatment	Radiation: head and neck radiation; RON and non-RON: nasopharyngeal carcinoma patients recieved head and neck radiation; Normal: normal individuals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BCVA	best corrected visual acuity	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
vessel density in the macular area	through study completion, an average of 1 year
vessel density in the ONH area	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Study Director: Zijing Li, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: May 29, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): June 9, 2023
• Last Update Submitted That Met QC Criteria: May 29, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Optic Nerve Diseases
• Other Study ID Numbers: SYSKY-2022-495-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No