Viewing Study NCT01253759


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Study NCT ID: NCT01253759
Status: COMPLETED
Last Update Posted: 2013-05-03
First Post: 2009-03-25
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Long Term Results of Combined Transpupillary Thermotherapy (TTT) Indocyanine Green (ICG) Based Photodynamic Therapy (PDT) in Choroidal Melanoma
Sponsor: New England Retina Associates
Organization:

Study Overview

Official Title: 10 Years Report of Combined Simultaneous Transpupillary Thermotherapy and ICG-based Photodynamic Therapy for Choroidal Melanoma
Status: COMPLETED
Status Verified Date: 2013-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is a report of 10 years results of combined Transpupillary thermotherapy (TTT) treatment with Indocyanine green (ICG) in controlling small and medium-sized choroidal melanomas.
Detailed Description: The study was done in a Clinical practice setting. Forty six eyes of 46 patients with small or medium-sized choroidal melanomas were treated with i-TTT using infrared light delivered from a diode laser. All patients were evaluated to rule out systemic metastasis and underwent a complete ophthalmological evaluation including: Slit lamp biomicroscopy, dilated fundus examination, Fluorescein angiography, Optical coherence tomography and A/B ultrasonography. Main outcome measures were: Changes in visual acuity, complications associated with the treatment and local control of the tumor.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: