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NCT01253759 Clinical Trial

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

Choroidal Melanoma Clinical Trial

Official title:
10 Years Report of Combined Simultaneous Transpupillary Thermotherapy and ICG-based Photodynamic Therapy for Choroidal Melanoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01253759
Other study ID # NERA-2
Secondary ID
Status Completed
Phase Phase 4
First received March 25, 2009
Last updated May 1, 2013
Start date January 2009
Est. completion date March 2009

Study information
Verified date May 2013
Source New England Retina Associates
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date March 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 95 Years
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Procedure:
• TTT + ICG-based PDT

Locations
Country Name City State
United States New England Retina Associates Hamden Connecticut

Sponsors (1)
Lead Sponsor Collaborator
New England Retina Associates

Country where clinical trial is conducted

United States, 

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