Status:
COMPLETED
Safety and Efficacy of Silicone Oil Tamponade for Surgical Attenuation of Radiation Damage in Choroidal Melanoma
Lead Sponsor:
University of Colorado, Denver
Conditions:
Choroidal Melanoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A prospective, experimental, case series of 20 patients, with choroidal melanoma, in which pars plana vitrectomy and Silicone oil as vitreous substitute will be used as intraocular shielding for atten...
Detailed Description
Melanoma arising from the choroid and ciliary body is the most common primary intraocular cancer. The Collaborative Ocular Melanoma Study (COMS) randomized clinical trial of I-125 brachytherapy versus...
Eligibility Criteria
Inclusion
- All treatment-naïve patients with clinical diagnosis of primary choroidal melanoma, amenable to treatment with plaque brachytherapy, aged 18 or older regardless gender, race/ethnicity or existing medical condition unless they are specifically mentioned as exclusion criteria.
- Patients with best corrected visual acuity of 20/400 or better in the study eye.
- Patients in whom the calculated dose of radiation to the optic nerve or macula is \> 25 Gray (Gy).
- Tumor inclusion criteria:
- Unilateral choroidal melanoma, medium size as defined by COMS classification:
- At least 2.5 mm in height, but no more than 10 mm in height (no more than 8.0 mm whenever the tumor was near the optic disc), and
- No more than 16.0 mm In diameter, regardless the shape by ultrasound.
Exclusion
- History of previous treatment for the choroidal melanoma.
- Pregnancy.
- Patients with any impairment which prevent attending follow-up appointments.
- The presence of concomitant significant life-treating medical conditions that significantly reduces the life expectancy to less than three years.
- The presence of other vision-treating ophthalmic condition, not directly related with choroidal melanoma which is likely to going to require intraocular surgery in the next three years.
- Clinical or radiological evidence of the presence of metastatic disease.
- The presence of significant media opacity (e.g. cataract) that precludes the investigator's ability to grade the tumor, performs retina surgery, or performs follow-up assessments.
- Patients that do not accept the informed consent
- Tumor exclusion criteria:
- Inability to successfully grade, stage and delineate the tumor by ultrasound.
- Tumor location that will prevent the correct placement of the plaque or have significant risk of optic nerve damage during plaque placement.
- Tumors that involved the anterior chamber angle, the iris or have detectable extrascleral extension.
- Tumor margin location \< 1000 µm from the fovea.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01460810
Start Date
July 1 2011
End Date
May 4 2021
Last Update
March 7 2022
Active Locations (1)
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1
University of Colorado Eye Center
Aurora, Colorado, United States, 80045