Evaluation of Early Retinal Vascular Modifications After Endoscopic Endonasal Pituitary Surgery

NCT04425954 | Completed

• 1 other identifier: PT 2006/20
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Adenoma

Outcome Measures

Primary Outcomes (1)

• 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

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
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participans were older than 45 years with pituitary adenoma. They did not present other ophthalmological and neurological diseases.

You may qualify if:

• 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

You may not qualify if:

• 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

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: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: January 1, 2019
• Primary Completion: March 1, 2019
• Study Completion: March 31, 2019
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

IT (1)