Clinical trial · Observational
Clinical Study of Structural and Functional Evaluation of the Visual Pathway
Multimodal Evaluation on Visual Pathway Predicts the Surgical Curative Effects in Sellar Area Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroimaging | — | UNRESOLVED | — |
| Pituitary Adenoma | Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
| Sellar Tumor | Sellar Region Neoplasm | ALIAS | 0.90 |
| Visual Impairment | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| automated visual field | Diagnostic Test | — | UNRESOLVED |
| diffusion tensor imaging | Diagnostic Test | — | UNRESOLVED |
| resting state fMRI | Diagnostic Test | — | UNRESOLVED |
| visual acuity | Diagnostic Test | — | UNRESOLVED |
| visual tasking state fMRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- TG group
- description
- Patients with visual impairment caused by chiasma compression from sellar area tumors will undergo the following examinations: resting state fMRI, visual tasking state fMRI, diffusion tensor imaging (DTI), visual acuity and automated visual field test.
- interventionNames
- Diagnostic Test: resting state fMRI
- Diagnostic Test: visual tasking state fMRI
- Diagnostic Test: diffusion tensor imaging
- Diagnostic Test: automated visual field
- Diagnostic Test: visual acuity
- label
- HC group
- description
- Volunteers with no visual impairment(visual acuity of both eyes \>1.0) or Nervous System disease will undergo the following examinations: resting state fMRI, visual tasking state fMRI, diffusion tensor imaging (DTI), visual acuity and automated visual field test.
- interventionNames
- Diagnostic Test: resting state fMRI
- Diagnostic Test: visual tasking state fMRI
- Diagnostic Test: diffusion tensor imaging
- Diagnostic Test: automated visual field
- Diagnostic Test: visual acuity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. patients with sellar area tumors ( including pituitary adenoma,craniopharyngioma and meningioma) resulting a visual deficit (loss of visual acuity or visual field). 2. Male or female between 18y to 60y. 3. Patients treated with transsphenoidal surgery. 4. Patients agreeing to participate in the study and willing to sign an informed consent. Exclusion Criteria: 1. tumor height ≥ 4cm. 2. Patients with recurrent tumors, previous craniotomy or gamma knife treatment 3. Visual impairment caused by other diseases. 4. Mental disorders, inability to cooperate with treatment and follow up visits. 5. Patients with other serious complications.
References
Publications (2)
- RESULTBackner Y, Kuchling J, Massarwa S, Oberwahrenbrock T, Finke C, Bellmann-Strobl J, Ruprecht K, Brandt AU, Zimmermann H, Raz N, Paul F, Levin N. Anatomical Wiring and Functional Networking Changes in the Visual System Following Optic Neuritis. JAMA Neurol. 2018 Mar 1;75(3):287-295. doi: 10.1001/jamaneurol.2017.3880. PMID 29297053
- RESULTHepp DH, Foncke EMJ, Olde Dubbelink KTE, van de Berg WDJ, Berendse HW, Schoonheim MM. Loss of Functional Connectivity in Patients with Parkinson Disease and Visual Hallucinations. Radiology. 2017 Dec;285(3):896-903. doi: 10.1148/radiol.2017170438. Epub 2017 Sep 27. PMID 28952907