Safety and Efficacy of Silicone Oil Tamponade for Surgical Attenuation of Radiation Damage in Choroidal Melanoma

NCT01460810 | Completed

• 1 other identifier: 11-0366
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Choroidal Melanoma

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• Severe Visual Loss

  3 years

Study Arms (1)

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.

Other: 1000CsK Silicon Oil Tamponade

Interventions

1000CsK Silicon Oil Tamponade OTHER

Details covered in arm description

1000CsK Silicon Oil Tamponade

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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:
• 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.
• 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
• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Eye Center

Aurora, Colorado, 80045, United States

Location

Related Publications (18)

• 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.

  PMID: 11158813 BACKGROUND

• Quivey 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.

  PMID: 8330990 BACKGROUND

• Oliver 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.

  PMID: 18838887 BACKGROUND

• Diener-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.

  PMID: 11448319 BACKGROUND

• Oittinen 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.

  PMID: 17545559 BACKGROUND

• Collaborative 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.

  PMID: 11346394 BACKGROUND

• Shields 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.

  PMID: 7155529 BACKGROUND

• Augsburger 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.

  PMID: 3518677 BACKGROUND

• Adams 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.

  PMID: 3415941 BACKGROUND

• Oliver 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.

  PMID: 20625051 BACKGROUND

• Finger 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.

  PMID: 2211021 BACKGROUND

• Soheilian 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.

  PMID: 16737520 BACKGROUND

• Halberstadt 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.

  PMID: 16705505 BACKGROUND

• Cheung 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.

  PMID: 20580421 BACKGROUND

• Rizzo 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.

  PMID: 20616684 BACKGROUND

• Jones S, Edwards RT. Diabetic retinopathy screening: a systematic review of the economic evidence. Diabet Med. 2010 Mar;27(3):249-56. doi: 10.1111/j.1464-5491.2009.02870.x.

  PMID: 20536486 BACKGROUND

• Polak BC, Crijns H, Casparie AF, Niessen LW. Cost-effectiveness of glycemic control and ophthalmological care in diabetic retinopathy. Health Policy. 2003 Apr;64(1):89-97. doi: 10.1016/s0168-8510(02)00143-4.

  PMID: 12644331 BACKGROUND

• Palmer AJ, Weiss C, Sendi PP, Neeser K, Brandt A, Singh G, Wenzel H, Spinas GA. The cost-effectiveness of different management strategies for type I diabetes: a Swiss perspective. Diabetologia. 2000 Jan;43(1):13-26. doi: 10.1007/s001250050003.

  PMID: 10672449 BACKGROUND

MeSH Terms

Conditions

Uveal Melanoma

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Study Officials

• Scott C Oliver, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Raul Velez-Montoya, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2011
• First Posted: October 27, 2011
• Study Start: July 1, 2011
• Primary Completion: May 4, 2021
• Study Completion: May 4, 2021
• Last Updated: March 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)