Long Term Results of Combined Transpupillary Thermotherapy (TTT) Indocyanine Green (ICG) Based Photodynamic Therapy (PDT) in Choroidal Melanoma
| Tracking Information | |||||
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| First Received Date ICMJE | March 25, 2009 | ||||
| Last Updated Date | May 1, 2013 | ||||
| Start Date ICMJE | January 2009 | ||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01253759 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Long Term Results of Combined Transpupillary Thermotherapy (TTT) Indocyanine Green (ICG) Based Photodynamic Therapy (PDT) in Choroidal Melanoma | ||||
| Official Title ICMJE | 10 Years Report of Combined Simultaneous Transpupillary Thermotherapy and ICG-based Photodynamic Therapy for Choroidal Melanoma | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Subjects selected from retina specialist general patient population. |
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| Condition ICMJE | Choroidal Melanoma | ||||
| Intervention ICMJE | Procedure: TTT + ICG-based PDT | ||||
| Study Group/Cohort (s) | 1
Combined treatment of Transpupillary Thermotherapy and ICG-based photodynamic therapy (PDT)
Intervention: Procedure: TTT + ICG-based PDT |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 46 | ||||
| Completion Date | March 2009 | ||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 95 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01253759 | ||||
| Other Study ID Numbers ICMJE | NERA-2 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Peter E. Liggett, New England Retina Associates | ||||
| Study Sponsor ICMJE | New England Retina Associates | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | New England Retina Associates | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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