Optic Radiation Neuropathy Following Radiotherapy ProcedureNCT05895851
Optical Coherence Tomography Angiography Characteristics of Radiation Optic Neuropathy
An observational study of Optic Radiation Neuropathy Following Radiotherapy Procedure, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Optic Radiation Neuropathy Following Radiotherapy Procedure
- What is being tested?
- head and neck radiation
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- other diseases that may cause sight loss, such as stroke, glaucoma, optic neuritis, ischemic optic neuropathy and other optic neuropathy and retinal diseases;
- NPC recurrence or metastase;
- uncontrollable diabetes mellitus, hypertension and other serious systemic diseases;
- lens opacity that affected imaging;
- 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
- a history of intraocular surgery.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- head and neck radiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
head and neck radiationRadiation
RON and non-RON: nasopharyngeal carcinoma patients recieved head and neck radiation; Normal: normal individuals.
| Study group | Role | What they receive |
|---|---|---|
| RON | Not described Receives: Radiation: head and neck radiation | |
| non-RON | non-RON but with radiiation treatment Receives: Radiation: head and neck radiation | |
| Normal | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
best corrected visual acuity
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
vessel density in the macular area
Measured: through study completion, an average of 1 year
vessel density in the ONH area
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start1 Jun 2018
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic Radiation Neuropathy Following Radiotherapy ProcedureStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zijing Li, Study director, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895851
- Sponsor's protocol ID
- SYSKY-2022-495-01
- Status last verified
- May 2023
- First submitted
- 18 May 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Angiography Characteristics of Radiation Optic Neuropathy
- ClinicalTrials.gov ID
- NCT05895851
- Acronym / sponsor ID
- SYSKY-2022-495-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RON | – | Radiation: head and neck radiation |
| non-RON | – | Radiation: head and neck radiationnon-RON but with radiiation treatment |
| Normal | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- other diseases that may cause sight loss, such as stroke, glaucoma, optic neuritis, ischemic optic neuropathy and other optic neuropathy and retinal diseases;
- NPC recurrence or metastase;
- uncontrollable diabetes mellitus, hypertension and other serious systemic diseases;
- lens opacity that affected imaging;
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| head and neck radiationRON and non-RON: nasopharyngeal carcinoma patients recieved head and neck radiation; Normal: normal individuals. | Radiation | RON, non-RON |
Primary outcome
BCVA
Time frame: through study completion, an average of 1 year
best corrected visual acuity
2 secondary outcomes
vessel density in the macular area
Time frame: through study completion, an average of 1 year
vessel density in the ONH area
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zijing Li study director
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Optic Radiation Neuropathy Following Radiotherapy Procedure, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCVA (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.