Optical Coherence Tomography Angiography Characteristics of Radiation Optic Neuropathy

Completed

• Conditions: Optic Radiation Neuropathy Following Radiotherapy Procedure
• Interventions: Radiation: head and neck radiation

• Registration Number: NCT05895851
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

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.

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 Timeline

• Study Start: 2018-06-01
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2023-05
• Study First Submitted: 2023-05-18
• Study First Submitted QC: 2023-05-29
• Last Update Submitted: 2023-05-29
• Study First Posted: 2023-06-09
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-RON	head and neck radiation	non-RON but with radiiation treatment
RON	head and neck radiation	-

Primary Outcome Measures

Name	Time	Method
BCVA	through study completion, an average of 1 year	best corrected visual acuity

Secondary Outcome Measures

Name	Time	Method
vessel density in the ONH area	through study completion, an average of 1 year
vessel density in the macular area	through study completion, an average of 1 year

Trial Locations

Locations (1)

Zijing Li; 🇨🇳 Guangzhou, China