Predictive OCTA Biomarkers After Endoscopic Endonasal Pituitary Surgery

Study Overview
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Brief Summary
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This study evaluates the structural parameters, by spectral domain optical coherence tomography (OCT), retinal vessel density, using OCT angiography, and visual acuity in patients that received endoscopic endonasal approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.

Detailed Description
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The primary outcome was to detect the changes in visual acuity, retinal structural and vascular features at 48 hours and 1 year after Endoscopic Endonasal Approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve. The secondary outcome was to identify potential biomarker that could predict the functional recovery at 1 year follow up.

Official Title
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Optical Cohrence Tomography Angiography as a New Predictive Biomarker in Anatomical and Functional Recovery After Endoscopic Endonasal Pituitary Surgery: a Prospective Study

Conditions
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Pituitary Adenoma

Intervention / Treatment
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* Procedure: Endoscopic Endonasal Pituitary Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age older than 40 years diagnosis of pituitary adenoma treatment-naïve with Endoscopic Endonasal Pituitary Surgery absence of other neurological diseases absence of vitreoretinal and vascular retinal diseases Exclusion Criteria: age younger than 40 years No diagnosis of pituitary adenoma previous treatments with Endoscopic Endonasal Pituitary Surgery presence of neurological diseases presence of vitreoretinal and vascular retinal diseases

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endoscopic Endonasal Pituitary Surgery|Surgical treatment consisted of an endoscopic endonasal approach using a rigid 0-degree endoscope, 18 cm in length and 4 mm in diameter.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between retinal structures before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery | 8 patients with pituitary adenoma compressing optic chiasm. Changes in thickness of ganglion cell complex (microns) and in thickness of retinal nerve fiber layer (microns) before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery | 48 hours and 1 year follow up | 
| Comparison between retinal microvasculature before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery | 8 patients with pituitary adenoma compressing optic chiasm. Changes in retinal vessel density (percent) in macular and papillary regions before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery | 48 hours and 1 year follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between retinal structures and visual acuity after Endoscopic Endonasal Pituitary Surgery | 8 patients with pituitary adenoma compressing optic chiasm underwent Endoscopic Endonasal Pituitary Surgery. Correlation between ganglion cell complex, retinal nerve fiber layer thicknesses (microns) at baseline and visual acuity recovery (logMAR) 1 year after surgery. | 1 year follow up | 
| Correlation between retinal microvasculature and visual acuity after Endoscopic Endonasal Pituitary Surgery | 8 patients with pituitary adenoma compressing optic chiasm underwent Endoscopic Endonasal Pituitary Surgery. Correlation between retinal vessel density (percent) at baseline and visual acuity recovery (logMAR) 1 year after surgery. | 1 year follow up |