Long-term Follow up for Retinal Vascular Changes After Endoscopic Endonasal Pituitary Surgery.

Completed

• Conditions: Pituitary Adenoma

• Registration Number: NCT04546386
• Lead Sponsor: Federico II University

Brief Summary

This study investigates the retinal vascular features, using optical coherence tomography angiography, in patients during one year's follow up after the endoscopic endonasal surgery to remove an intra-suprasellar pituitary adenoma compressing the optic nerve.

Detailed Description

The role of the optical coherence tomography angiography to detect the changes in retinal vascular networks in patients after 48 hours and 1 year from the endoscopic endonasal surgery to remove an intra-suprasellar pituitary adenoma compressing the optic nerve.

The optical coherence tomography angiography allows a detailed and quantitative analysis of the retinal vascular networks and to follow their changes over time.

Study Timeline

• Study Start: 2019-01-10
• Primary Completion: 2020-03-10
• Study Completion: 2020-03-25
• Study First Submitted: 2020-09-08
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-14
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

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

Inclusion Criteria

• age older than 45 years
• diagnosis of pituitary adenoma
• treatment-naive with endoscopic endonasal pituitary surgery
• absence of other neurological disease
• absence of vitreoretinal and vascular retinal diseases

Exclusion Criteria

• age younger than 45 years
• No diagnosis of pituitary adenoma
• previous treatment with endoscopic endonasal pituitary surgery
• presence of neurological disease
• presence of vitreretinal 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 retinal vascular network in patients underwent endoscopic endonasal pituitary surgery, by optical coherence tomography angiography, during long-term follow up.	one year	To evaluate the changes in vessel density of the retinal vascular network 48 hours and 1 year after endoscopic endonasal pituitary surgery for the removal of an intra-suprasellar pituitary adenoma compressing the optic nerve, using optical coherence tomography angiography. The parameter analyzed by optical coherence tomography angiography was the vessel density of the retinal vascular network.

Trial Locations

Locations (1)

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