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

Pituitary Adenoma Clinical Trial

Official title:

Retinal Vascular Changes After Endoscopic Endonasal Pituitary Surgery During One Year's Follow up, by Optical Coherence Tomography Angiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04546386
• Other study ID #: 1003/19
• Status: Completed
• Start date: January 10, 2019
• Est. completion date: March 25, 2020

Study information

• Verified date: February 2021
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 25, 2020
• Est. primary completion date: March 10, 2020
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

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 retinal vascular network in patients underwent endoscopic endonasal pituitary surgery, by optical coherence tomography angiography, during long-term follow up.	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.	one year