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

NCT04546386 | Completed

• 1 other identifier: 1003/19
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Adenoma

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Endoscopic endonasal pituitary surgery PROCEDURE

Surgical treatment consisted of an endoscopic endonasal approach using a rigid 0-degree endoscope, 18 cm in length and 4 mm in diameter

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The partecipants were older than 45 years and they underwent long term follow up after endoscopic endonasal pituitary surgery to remove pituitary adenoma. They did not present other neurological and ophthalmological diseases

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples "Federico II"

Naples, 80100, Italy

Location

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Gilda Cennamo

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 14, 2020
• Study Start: January 10, 2019
• Primary Completion: March 10, 2020
• Study Completion: March 25, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-02

Locations

IT (1)