CClinicalTrials.gg
CompletedNCT04546386Updated Feb 3, 2021

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

An observational study in Pituitary Adenoma, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-02-03.

Sponsored by Federico II University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
14
Ages
45 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

03

In context

Adenoma

657 studies on the registry are indexed under Adenoma; 98 are open to participants now.

This study's enrollment of 14 is below the median of 300 across 226 observational studies indexed under Adenoma.

Browse Adenoma studies →

Lead sponsor

Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
All
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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
14 participants (actual)
Patient registry
No

Interventions

  • ProcedureEndoscopic 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

06

What researchers measure

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.

    Time frame: one year

07

Study locations

1 site
  • University of Naples "Federico II"
    Naples, 80100, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04546386
Lead sponsor
Federico II University
Responsible party
Gilda Cennamo (Principal Investigator, Federico II University) — Principal investigator
First posted
Sep 14, 2020
Start date
Jan 10, 2019
Primary completion
Mar 10, 2020
Completion
Mar 25, 2020
Last update
Feb 3, 2021

Study contacts

Gilda Cennamo
principal investigator · Federico II University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion