Choroidal MelanomaNCT01460810
Safety and Efficacy of Silicone Oil Tamponade for Surgical Attenuation of Radiation Damage in Choroidal Melanoma
A study testing 1000CsK Silicon Oil Tamponade in people with Choroidal Melanoma, run by University of Colorado, Denver at 1 site in United States.
Trial 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 attenuating the deleterious effects of radiation dose delivered to healthy ocular tissue during Iodine-125 plaque… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choroidal Melanoma
- What is being tested?
- 1000CsK Silicon Oil Tamponade
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to 4 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Eye Center
Aurora, Colorado, 80045
About this study
Official title: A Prospective Pilot Study of Surgical Radiation Shielding With Vitrectomy & Silicone Oil Tamponade for the Protection of Radiation-induced Ocular Injury in the Treatment of Choroidal Melanoma With Radioactive Iodine-125 Plaque Brachytherapy
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 attenuating the deleterious effects of radiation dose delivered to healthy ocular tissue during Iodine-125 plaque brachytherapy treatment and assess if the treatment can reduce the incidence and severity of radiation-induced adverse effects like radiation retinopathy and permanent loss of vision.
Read the 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 enucleation for medium-sized choroidal melanoma (2.5-10.0 mm in thickness and ≤ 16 mm in diameter) showed that, for patients who met the eligibility criteria, there was no statistically significant difference in all-cause mortality between I-125 brachytherapy and enucleation 5, 10, and 12 years following treatment. The COMS trial supported the use of globe-conserving I-125 brachytherapy. Following brachytherapy, however, visual acuity in the treated eye generally declined at a rate of approximately 2 lines of visual acuity per year and nearly 45% of patients lost ambulatory vision (≤20/200) in the treated eye by 3 years.
Adverse effects of plaque brachytherapy include cataract, radiation-associated proliferative retinopathy, maculopathy and papillopathy. Radiation maculopathy, which may result in decreased central vision, cystoid macular edema (CME), macular ischemia, and chorioretinal atrophy, was reported in other series in 18% to 43% of treated eyes within 5 years after brachytherapy. Typical onset occurred 18-24 months following treatment. Primary risk factors for radiation papillopathy and maculopathy were total radiation dose to the affected structures, proximity of the tumor to the affected structures and systemic conditions such as diabetes mellitus. No treatment for radiation maculopathy or papillopathy has been proven to be effective in a randomized clinical trial.
Radiation injury to vital structures may be avoided or shielded with the use of materials such as lead that have a higher effective atomic number and density than tissue. However, solid metals are not amenable to use within the eye (Figure 1).
There have been previous efforts to try to use a vitreous substitute in order to protect intraocular structures from the deleterious effects of radiations. In an animal study, Finger et al, demonstrated that iodinated contrast agents (iophendylate, iohexol, and iopamidol) could block radiation intraocularly. But these substances were highly toxic and could not be retained in the eye due to high water solubility.
The technique of vitrectomy and oil tamponade during plaque brachytherapy has been performed previously in humans by Dr. Tara McCannel at UCLA. During a paper presentation at the 2010 meeting of the American Society of Retina Specialist in Vancouver, BC, the first series of 10 patients were presented, and no complications of the technique were reported. It is now a commonly applied technique at this center for treatment of choroidal melanoma (Oncology Times 2010; 32(14):36, UCLA, Clinical Update 2011; 20(1):1, 4)
In this prospective pilot study the investigators propose that patients will undergo standard plaque placement for treatment of their ocular melanoma in addition to pars plana vitrectomy and silicone oil infusion. When patients return for their scheduled plaque removal one week later, they will also undergo removal of the silicone oil from the eye. Placement of silicone oil should not alter the radiation dose delivered to the tumor, as there is no physical space between the tumor and the radioactive plaque for silicone oil to be present. The reduction in radiation to healthy ocular structures by using the oil technique may be sufficient to avoid the clinical complications caused by radiation-induced injury.
- Conditions
- Choroidal Melanoma
- Being tested
- 1000CsK Silicon Oil Tamponade
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1000CsK Silicon Oil TamponadeOther
Details covered in arm description
| Study group | Role | What they receive |
|---|---|---|
| 1000CsK Silicon Oil Tamponade | Experimental | In 20 patients, a standard three-port vitrectomy will be performed. Following a standard air-fluid exchange, the eye will be filled with Silikon-1000 silicone oil in standard fashion. At a subsequent surgery, a standard two-port pars plana vitrectomy will be performed to remove the silicone oil and replace it with saline. The removed silicone oil will be tested onsite for traces of radiation. Receives: Other: 1000CsK Silicon Oil Tamponade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vision Loss
The loss of 5 or more letters from the base line on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart after 1 and 2 years of follow-up.
Measured: 1 year
Secondary outcomes (1)
Severe Visual Loss
The loss of 15 or more letters from base line on and ETDRS chart after three years of follow-up. Contrast sensitivity loss: the loss of 2 or more lines on a Pelli-Robson Chart after 1 and 2 years of follow-up.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2011 (estimated)
- Study startJul 2011
- Primary completion4 May 2021
- Study completion4 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Choroidal MelanomaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott C Oliver, MD, Principal investigator, University of Colorado, DenverRaul Velez-Montoya, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460810
- Sponsor's protocol ID
- 11-0366
- Status last verified
- Mar 2022
- First submitted
- 25 Oct 2011
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will be released in publications, but no information will be used that could disclose the subjects' identity.
Publications
Melia BM, Abramson DH, Albert DM, Boldt HC, Earle JD, Hanson WF, Montague P, Moy CS, Schachat AP, Simpson ER, Straatsma BR, Vine AK, Weingeist TA; Collaborative Ocular Melanoma Study Group. Collaborative ocular melanoma study (COMS) randomized trial of I-125 brachytherapy for medium choroidal melanoma. I. Visual acuity after 3 years COMS report no. 16. Ophthalmology. 2001 Feb;108(2):348-66. doi: 10.1016/s0161-6420(00)00526-1.
PubMed 11158813Quivey JM, Char DH, Phillips TL, Weaver KA, Castro JR, Kroll SM. High intensity 125-iodine (125I) plaque treatment of uveal melanoma. Int J Radiat Oncol Biol Phys. 1993 Jul 15;26(4):613-8. doi: 10.1016/0360-3016(93)90277-3.
PubMed 8330990Oliver SC, Young TA, Kobe LH, Leu MY, Lee SP, Chun MW, Straatsma BR. Assessment of central vision and macular structure in patients undergoing iodine-125 brachytherapy for ciliochoroidal melanoma. Am J Clin Oncol. 2008 Oct;31(5):488-92. doi: 10.1097/COC.0b013e31816d1c94.
PubMed 18838887Diener-West M, Earle JD, Fine SL, Hawkins BS, Moy CS, Reynolds SM, Schachat AP, Straatsma BR; Collaborative Ocular Melanoma Study Group. The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma, III: initial mortality findings. COMS Report No. 18. Arch Ophthalmol. 2001 Jul;119(7):969-82. doi: 10.1001/archopht.119.7.969.
PubMed 11448319Oittinen HA, O'Shaughnessy M, Cullinane AB, Keohane C. Malignant melanoma of the ciliary body presenting as extraocular metastasis in the temporalis muscle. J Clin Pathol. 2007 Jul;60(7):834-5. doi: 10.1136/jcp.2005.033613. Epub 2007 Jun 1. No abstract available.
PubMed 17545559Collaborative Ocular Melanoma Study Group.. Assessment of metastatic disease status at death in 435 patients with large choroidal melanoma in the Collaborative Ocular Melanoma Study (COMS): COMS report no. 15. Arch Ophthalmol. 2001 May;119(5):670-6. doi: 10.1001/archopht.119.5.670.
PubMed 11346394Shields JA, Augsburger JJ, Brady LW, Day JL. Cobalt plaque therapy of posterior uveal melanomas. Ophthalmology. 1982 Oct;89(10):1201-7. doi: 10.1016/s0161-6420(82)34658-8.
PubMed 7155529Augsburger JJ, Gamel JW, Sardi VF, Greenberg RA, Shields JA, Brady LW. Enucleation vs cobalt plaque radiotherapy for malignant melanomas of the choroid and ciliary body. Arch Ophthalmol. 1986 May;104(5):655-61. doi: 10.1001/archopht.1986.01050170045019.
PubMed 3518677Adams KS, Abramson DH, Ellsworth RM, Haik BG, Bedford M, Packer S, Seddon J, Albert D, Polivogianis L. Cobalt plaque versus enucleation for uveal melanoma: comparison of survival rates. Br J Ophthalmol. 1988 Jul;72(7):494-7. doi: 10.1136/bjo.72.7.494.
PubMed 3415941Oliver SC, Leu MY, DeMarco JJ, Chow PE, Lee SP, McCannel TA. Attenuation of iodine 125 radiation with vitreous substitutes in the treatment of uveal melanoma. Arch Ophthalmol. 2010 Jul;128(7):888-93. doi: 10.1001/archophthalmol.2010.117.
PubMed 20625051Finger PT, Ho TK, Fastenberg DM, Hyman RA, Stroh EM, Packer S, Perry HD. Intraocular radiation blocking. Invest Ophthalmol Vis Sci. 1990 Sep;31(9):1724-30.
PubMed 2211021Soheilian M, Mazareei M, Mohammadpour M, Rahmani B. Comparison of silicon oil removal with various viscosities after complex retinal detachment surgery. BMC Ophthalmol. 2006 May 31;6:21. doi: 10.1186/1471-2415-6-21.
PubMed 16737520Halberstadt M, Domig D, Kodjikian L, Koerner F, Garweg JG. PVR recurrence and the timing of silicon oil removal. Klin Monbl Augenheilkd. 2006 May;223(5):361-6. doi: 10.1055/s-2006-926594.
PubMed 16705505Cheung N, Mitchell P, Wong TY. Diabetic retinopathy. Lancet. 2010 Jul 10;376(9735):124-36. doi: 10.1016/S0140-6736(09)62124-3. Epub 2010 Jun 26.
PubMed 20580421Rizzo S, Belting C, Genovesi-Ebert F, di Bartolo E. Incidence of retinal detachment after small-incision, sutureless pars plana vitrectomy compared with conventional 20-gauge vitrectomy in macular hole and epiretinal membrane surgery. Retina. 2010 Jul-Aug;30(7):1065-71. doi: 10.1097/IAE.0b013e3181cd48b0.
PubMed 20616684
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study of Surgical Radiation Shielding With Vitrectomy & Silicone Oil Tamponade for the Protection of Radiation-induced Ocular Injury in the Treatment of Choroidal Melanoma With Radioactive Iodine-125 Plaque Brachytherapy
- ClinicalTrials.gov ID
- NCT01460810
- Acronym / sponsor ID
- 11-0366
- Conditions
- Choroidal Melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 27 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 attenuating the deleterious effects of radiation dose delivered to healthy ocular tissue during Iodine-125 plaque brachytherapy treatment and assess if the treatment can reduce the incidence and severity of radiation-induced adverse effects like radiation retinopathy and permanent loss of vision.
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 enucleation for medium-sized choroidal melanoma (2.5-10.0 mm in thickness and ≤ 16 mm in diameter) showed that, for patients who met the eligibility criteria, there was no statistically significant difference in all-cause mortality between I-125 brachytherapy and enucleation 5, 10, and 12 years following treatment. The COMS trial supported the use of globe-conserving I-125 brachytherapy. Following brachytherapy, however, visual acuity in the treated eye generally declined at a rate of approximately 2 lines of visual acuity per year and nearly 45% of patients lost ambulatory vision (≤20/200) in the treated eye by 3 years.
Adverse effects of plaque brachytherapy include cataract, radiation-associated proliferative retinopathy, maculopathy and papillopathy. Radiation maculopathy, which may result in decreased central vision, cystoid macular edema (CME), macular ischemia, and chorioretinal atrophy, was reported in other series in 18% to 43% of treated eyes within 5 years after brachytherapy. Typical onset occurred 18-24 months following treatment. Primary risk factors for radiation papillopathy and maculopathy were total radiation dose to the affected structures, proximity of the tumor to the affected structures and systemic conditions such as diabetes mellitus. No treatment for radiation maculopathy or papillopathy has been proven to be effective in a randomized clinical trial.
Radiation injury to vital structures may be avoided or shielded with the use of materials such as lead that have a higher effective atomic number and density than tissue. However, solid metals are not amenable to use within the eye (Figure 1).
There have been previous efforts to try to use a vitreous substitute in order to protect intraocular structures from the deleterious effects of radiations. In an animal study, Finger et al, demonstrated that iodinated contrast agents (iophendylate, iohexol, and iopamidol) could block radiation intraocularly. But these substances were highly toxic and could not be retained in the eye due to high water solubility.
The technique of vitrectomy and oil tamponade during plaque brachytherapy has been performed previously in humans by Dr. Tara McCannel at UCLA. During a paper presentation at the 2010 meeting of the American Society of Retina Specialist in Vancouver, BC, the first series of 10 patients were presented, and no complications of the technique were reported. It is now a commonly applied technique at this center for treatment of choroidal melanoma (Oncology Times 2010; 32(14):36, UCLA, Clinical Update 2011; 20(1):1, 4)
In this prospective pilot study the investigators propose that patients will undergo standard plaque placement for treatment of their ocular melanoma in addition to pars plana vitrectomy and silicone oil infusion. When patients return for their scheduled plaque removal one week later, they will also undergo removal of the silicone oil from the eye. Placement of silicone oil should not alter the radiation dose delivered to the tumor, as there is no physical space between the tumor and the radioactive plaque for silicone oil to be present. The reduction in radiation to healthy ocular structures by using the oil technique may be sufficient to avoid the clinical complications caused by radiation-induced injury.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1000CsK Silicon Oil Tamponade | Experimental | Other: 1000CsK Silicon Oil TamponadeIn 20 patients, a standard three-port vitrectomy will be performed. Following a standard air-fluid exchange, the eye will be filled with Silikon-1000 silicone oil in standard fashion. At a subsequent surgery, a standard two-port pars plana vitrectomy will be performed to remove the silicone oil and replace it with saline. The removed silicone oil will be tested onsite for traces of radiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
- Unilateral choroidal melanoma, medium size as defined by COMS classification:
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1000CsK Silicon Oil TamponadeDetails covered in arm description | Other | 1000CsK Silicon Oil Tamponade |
Primary outcome
Vision Loss
Time frame: 1 year
The loss of 5 or more letters from the base line on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart after 1 and 2 years of follow-up.
1 secondary outcome
Severe Visual Loss
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Background: PubMed 11158813Melia BM, Abramson DH, Albert DM, Boldt HC, Earle JD, Hanson WF, Montague P, Moy CS, Schachat AP, Simpson ER, Straatsma BR, Vine AK, Weingeist TA; Collaborative Ocular Melanoma Study Group. Collaborative ocular melanoma study (COMS) randomized trial of I-125 brachytherapy for medium choroidal melanoma. I. Visual acuity after 3 years COMS report no. 16. Ophthalmology. 2001 Feb;108(2):348-66. doi: 10.1016/s0161-6420(00)00526-1.
- Background: PubMed 8330990Quivey JM, Char DH, Phillips TL, Weaver KA, Castro JR, Kroll SM. High intensity 125-iodine (125I) plaque treatment of uveal melanoma. Int J Radiat Oncol Biol Phys. 1993 Jul 15;26(4):613-8. doi: 10.1016/0360-3016(93)90277-3.
- Background: PubMed 18838887Oliver SC, Young TA, Kobe LH, Leu MY, Lee SP, Chun MW, Straatsma BR. Assessment of central vision and macular structure in patients undergoing iodine-125 brachytherapy for ciliochoroidal melanoma. Am J Clin Oncol. 2008 Oct;31(5):488-92. doi: 10.1097/COC.0b013e31816d1c94.
- Background: PubMed 11448319Diener-West M, Earle JD, Fine SL, Hawkins BS, Moy CS, Reynolds SM, Schachat AP, Straatsma BR; Collaborative Ocular Melanoma Study Group. The COMS randomized trial of iodine 125 brachytherapy for choroidal melanoma, III: initial mortality findings. COMS Report No. 18. Arch Ophthalmol. 2001 Jul;119(7):969-82. doi: 10.1001/archopht.119.7.969.
- Background: PubMed 17545559Oittinen HA, O'Shaughnessy M, Cullinane AB, Keohane C. Malignant melanoma of the ciliary body presenting as extraocular metastasis in the temporalis muscle. J Clin Pathol. 2007 Jul;60(7):834-5. doi: 10.1136/jcp.2005.033613. Epub 2007 Jun 1. No abstract available.
- Background: PubMed 11346394Collaborative Ocular Melanoma Study Group.. Assessment of metastatic disease status at death in 435 patients with large choroidal melanoma in the Collaborative Ocular Melanoma Study (COMS): COMS report no. 15. Arch Ophthalmol. 2001 May;119(5):670-6. doi: 10.1001/archopht.119.5.670.
- Background: PubMed 7155529Shields JA, Augsburger JJ, Brady LW, Day JL. Cobalt plaque therapy of posterior uveal melanomas. Ophthalmology. 1982 Oct;89(10):1201-7. doi: 10.1016/s0161-6420(82)34658-8.
- Background: PubMed 3518677Augsburger JJ, Gamel JW, Sardi VF, Greenberg RA, Shields JA, Brady LW. Enucleation vs cobalt plaque radiotherapy for malignant melanomas of the choroid and ciliary body. Arch Ophthalmol. 1986 May;104(5):655-61. doi: 10.1001/archopht.1986.01050170045019.
- Background: PubMed 3415941Adams KS, Abramson DH, Ellsworth RM, Haik BG, Bedford M, Packer S, Seddon J, Albert D, Polivogianis L. Cobalt plaque versus enucleation for uveal melanoma: comparison of survival rates. Br J Ophthalmol. 1988 Jul;72(7):494-7. doi: 10.1136/bjo.72.7.494.
- Background: PubMed 20625051Oliver SC, Leu MY, DeMarco JJ, Chow PE, Lee SP, McCannel TA. Attenuation of iodine 125 radiation with vitreous substitutes in the treatment of uveal melanoma. Arch Ophthalmol. 2010 Jul;128(7):888-93. doi: 10.1001/archophthalmol.2010.117.
- Background: PubMed 2211021Finger PT, Ho TK, Fastenberg DM, Hyman RA, Stroh EM, Packer S, Perry HD. Intraocular radiation blocking. Invest Ophthalmol Vis Sci. 1990 Sep;31(9):1724-30.
- Background: PubMed 16737520Soheilian M, Mazareei M, Mohammadpour M, Rahmani B. Comparison of silicon oil removal with various viscosities after complex retinal detachment surgery. BMC Ophthalmol. 2006 May 31;6:21. doi: 10.1186/1471-2415-6-21.
- Individual participant dataSharing planned: No. Data will be released in publications, but no information will be used that could disclose the subjects' identity.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott C Oliver, MD principal investigator
University of Colorado, Denver
Raul Velez-Montoya, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1000CsK Silicon Oil Tamponade in people with Choroidal Melanoma, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vision Loss (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01460810, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.