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Clinical Study of Structural and Functional Evaluation of the Visual Pathway

NCT03591315 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2018-07-23

No results posted yet for this study

Summary

Sellar area tumors such as pituitary adenoma, craniopharyngioma and meningioma, etc, commonly lead to visual impairment symptoms. Patients suffer from a loss of visual acuity (VA) and visual field defects (VF) due to a local compression on the optic chiasma by the tumor. In the management of these patients, it is an important goal to evaluate their visual function throughout the treatment, so as to predict the outcome of the visual function .

Since the visual pathway contains a huge complex network of both structure and function, traditional simplex evaluation of VA and VF is obviously not enough. Former studies have revealed changes in the visual network and cortex structure in neurodegenerative diseases and optic neuritis, yet the functional and structural changes caused by local tumor compression and their relation to the visual cortex activity patterns needs further research.

The objective of this research is to asses the visual function in patients with sellar area tumor 1 week preoperatively (baseline),72 hours postoperatively(checking point 1) and at 3 months follow up(checkpoint 2). By using multimodal evaluation including visual resting and task state fMRI, diffusion tensor imaging (DTI), etc. The investigators aim to reveal the changes in functional connectivity (FC), amplitude of low frequency fluctuation (ALFF), regional homogeneity (REHO) ,visual cortex activity patterns and tract-based spatial statistics (TBSS).

Conditions

  • Pituitary Adenoma
  • Visual Impairment
  • Sellar Tumor
  • Neuroimaging

Interventions

DIAGNOSTIC_TEST

resting state fMRI

Define the visual resting state network.

DIAGNOSTIC_TEST

visual tasking state fMRI

Using visual task stimulation to identify the activation characteristic of primary visual cortex.

DIAGNOSTIC_TEST

diffusion tensor imaging

Define the integrity of white matter fibers in the visual pathway.

DIAGNOSTIC_TEST

automated visual field

Identify the existence and type of visual field defect.

DIAGNOSTIC_TEST

visual acuity

Assess the visual acuity by using ETDRS scales.

Sponsors & Collaborators

  • Xiangya Hospital of Central South University

    lead OTHER

Principal Investigators

  • Liu Z Xiong, MD/PhD · Neurosurgery department, Xiangya Hospital of Central South University, Changsha, Hunan, China

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2018-12-31
Completion
2019-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03591315 on ClinicalTrials.gov