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

NCT ID: NCT01253759

Last Updated: 2013-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-03-31

Brief Summary

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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

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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.

Conditions

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Choroidal Melanoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

Combined treatment of Transpupillary Thermotherapy and ICG-based photodynamic therapy (PDT)

TTT + ICG-based PDT

Intervention Type PROCEDURE

Interventions

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TTT + ICG-based PDT

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New England Retina Associates

OTHER

Sponsor Role lead

Responsible Party

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Peter E. Liggett

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter E Liggett, MD

Role: STUDY_DIRECTOR

New England Retina Associates

Locations

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New England Retina Associates

Hamden, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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NERA-2

Identifier Type: -

Identifier Source: org_study_id

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