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NCT03363126 Clinical Trial

Visual Outcome After Transsphenoidal Surgery for Pituitary Macroadenoma

Pituitary Tumor Clinical Trial

— RetroADEN  

Official title:
Visual Outcome After Transsphenoidal Surgery for Pituitary Macroadenoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03363126
Other study ID # CE_20160404_1_WEI
Secondary ID
Status Completed
Phase N/A
First received November 30, 2017
Last updated November 30, 2017
Start date September 1, 2015
Est. completion date June 20, 2016

Study information
Verified date November 2017
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 88
Est. completion date June 20, 2016
Est. primary completion date February 10, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Outcome
Type Measure Description Time frame Safety issue
Primary Post-operative gain in visual acuity Difference between pre-operative and post-operative visual acuity, expressed in LogMAR six months
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