Evaluation of Early Retinal Vascular Modifications After Endoscopic Endonasal Pituitary Surgery

Completed

• Conditions: Pituitary Adenoma

• Registration Number: NCT04425954
• Lead Sponsor: Federico II University

Brief Summary

This study evaluates the retinal vascular features using optical coherence tomography angiography in patients that received endoscopic endonasal approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.

Detailed Description

To investigate the potential role of optical coherence tomography angiography in predicting the postoperative recovery of retinal vascular network of the optic disc in patients before and at 3 months after Endoscopic Endonasal Approach for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.

The optical coherence tomography angiography represents a novel and non-invasive diagnostic technique that allows a detailed analysis of retinal vascular features.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-31
• Status Verified: 2020-06
• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-08
• Study First Posted: 2020-06-11
• Last Update Submitted: 2020-06-11
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• age older than 45 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 45 years
• No diagnosis of pituitary adenoma
• previous treatments with Endoscopic Endonasal Pituitary Surgery
• presence of neurological diseases
• presence of vitreoretinal and vascular retinal diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study of vessel density of the optic disc in patients underwent Endoscopic Endonasal Pituitary Surgery for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve.	48 hours	To evaluate the role of optical coherence tomography angiography in predicting the recovery of the vessel density of the optic disc after surgery, using optical coherence tomography angiography (OCTA). The parameter analyzed by OCTA was the vessel density of the optic disc (percent)

Trial Locations

Locations (1)

University of Naples "Federico II"; 🇮🇹 Naples, Italy