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Long Term Results of Combined Transpupillary Thermotherapy (TTT) Indocyanine Green (ICG) Based Photodynamic Therapy (PDT) in Choroidal Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter E. Liggett, New England Retina Associates
ClinicalTrials.gov Identifier:
NCT01253759
First received: March 25, 2009
Last updated: May 1, 2013
Last verified: May 2013

March 25, 2009
May 1, 2013
January 2009
January 2009   (final data collection date for primary outcome measure)
Not Provided
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Complete list of historical versions of study NCT01253759 on ClinicalTrials.gov Archive Site
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Long Term Results of Combined Transpupillary Thermotherapy (TTT) Indocyanine Green (ICG) Based Photodynamic Therapy (PDT) in Choroidal Melanoma
10 Years Report of Combined Simultaneous Transpupillary Thermotherapy and ICG-based Photodynamic Therapy for Choroidal Melanoma

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Non-Probability Sample

Subjects selected from retina specialist general patient population.

Choroidal Melanoma
Procedure: TTT + ICG-based PDT
1
Combined treatment of Transpupillary Thermotherapy and ICG-based photodynamic therapy (PDT)
Intervention: Procedure: TTT + ICG-based PDT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
March 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Small and medium-sized choroidal melanoma
  • Patients older than 18 years old.
  • Patients who can read and signed the informed consent.

Exclusion Criteria:

  • Patients with ocular inflammation.
  • Patients with another active ocular disease.
Both
18 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01253759
NERA-2
No
Peter E. Liggett, New England Retina Associates
New England Retina Associates
Not Provided
Study Director: Peter E Liggett, MD New England Retina Associates
New England Retina Associates
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP