Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04546386
Recruitment Status : Completed
First Posted : September 14, 2020
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Gilda Cennamo, Federico II University

Tracking Information
First Submitted Date September 8, 2020
First Posted Date September 14, 2020
Last Update Posted Date February 3, 2021
Actual Study Start Date January 10, 2019
Actual Primary Completion Date March 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2021)
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. [ Time Frame: one year ]
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.
Original Primary Outcome Measures
 (submitted: September 8, 2020)
Study of vessel density of the retinal vascular network in patients underwent endoscopic endonasal pitituary surgery, by optical coherence tomography angiography, during long-term follow up. [ Time Frame: one year ]
To evaluate the changes in vessel density of the retinal vascular network 48 hours and 1 year after endoscopic endonasal pitituary surgery for the removal of an intra-suprasellar pitituary 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.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-term Follow up for Retinal Vascular Changes After Endoscopic Endonasal Pituitary Surgery.
Official Title Retinal Vascular Changes After Endoscopic Endonasal Pituitary Surgery During One Year's Follow up, by Optical Coherence Tomography Angiography
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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

Condition Pituitary Adenoma
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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 8, 2020)
14
Original Actual Enrollment Same as current
Actual Study Completion Date March 25, 2020
Actual Primary Completion Date March 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04546386
Other Study ID Numbers 1003/19
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Gilda Cennamo, Federico II University
Study Sponsor Federico II University
Collaborators Not Provided
Investigators
Principal Investigator: Gilda Cennamo Federico II University
PRS Account Federico II University
Verification Date February 2021