Evaluation of Early Retinal Vascular Modifications After Endoscopic Endonasal Pituitary Surgery

Pituitary Adenoma Clinical Trial

Official title:

Early Retinal Vascular Modifications After Endoscopic Endonasal Pituitary Surgery: The Role of OCT- Angiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04425954
• Other study ID #: PT 2006/20
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: March 31, 2019

Study information

• Verified date: June 2020
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 31, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Italy	University of Naples "Federico II"	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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)	48 hours