Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Visual Outcome After Transsphenoidal Surgery for Pituitary Macroadenoma (RetroADEN)

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: NCT03363126
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:
Endoscopic endonasal transsphenoidal surgery is a procedure for the treatment of pituitary macroadenomas that cause visual impairment through optic chiasm compression. The aim of this retrospective study is to describe visual outcome after this procedure.

Condition or disease Intervention/treatment
Pituitary Tumor Optic Chiasm Disorder Procedure: Endonasal transsphenoidal pituitary tumor removal

Layout table for study information
Study Type : Observational
Actual Enrollment : 88 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Visual Outcome After Transsphenoidal Surgery for Pituitary Macroadenoma
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : February 10, 2016
Actual Study Completion Date : June 20, 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Endonasal transsphenoidal pituitary tumor removal
    Removal of pituitary tumor by transsphenoidal endonasal surgery


Primary Outcome Measures :
  1. Post-operative gain in visual acuity [ Time Frame: six months ]
    Difference between pre-operative and post-operative visual acuity, expressed in LogMAR



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated in the Rothschild Foundation (Paris) between 2009 and 2013 by transsphenoidal endonasal surgery for pituitary tumor causing optic chiasm compression and visual disorders
Criteria

Inclusion Criteria:

  • Pituitary tumor causing optic chiasm compression (documented on MRI or CT-scan)
  • Visual impairment caused by chiasm compression
  • Treatment by transsphenoidal endonasal surgery
  • Treatment in the Rothschild Foundation (Paris) between 2009 and 2013

Exclusion Criteria:

  • Ophtalmologic condition other than optic chiasm compression
Layout table for additonal information
Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03363126    
Other Study ID Numbers: CE_20160404_1_WEI
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pituitary Neoplasms
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms