Predictive OCTA Biomarkers After Endoscopic Endonasal Pituitary Surgery

NCT04840771 | Completed

• 1 other identifier: 04/21
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the structural parameters, by spectral domain optical coherence tomography (OCT), retinal vessel density, using OCT angiography, and visual acuity 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 (2)

• Comparison between retinal structures before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery

  8 patients with pituitary adenoma compressing optic chiasm. Changes in thickness of ganglion cell complex (microns) and in thickness of retinal nerve fiber layer (microns) before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery

  48 hours and 1 year follow up

• Comparison between retinal microvasculature before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery

  8 patients with pituitary adenoma compressing optic chiasm. Changes in retinal vessel density (percent) in macular and papillary regions before and 48 hours and 1 year after Endoscopic Endonasal Pituitary Surgery

  48 hours and 1 year follow up

Secondary Outcomes (2)

• Correlation between retinal structures and visual acuity after Endoscopic Endonasal Pituitary Surgery

  1 year follow up

• Correlation between retinal microvasculature and visual acuity after Endoscopic Endonasal Pituitary Surgery

  1 year follow up

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: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participans were older than 4 years with pituitary adenoma. They did not present other ophthalmological and neurological diseases.

You may qualify if:

• age older than 40 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 40 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: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: April 12, 2021
• Study Start: June 1, 2020
• Primary Completion: July 30, 2020
• Study Completion: July 31, 2020
• Last Updated: May 6, 2021

Record last verified: 2021-05

Locations

IT (1)