The Silicone Study

NCT00000140 | Completed Phase 3

• 1 other identifier: NEI-39
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare, through a randomized, multicenter surgical trial, the postoperative tamponade effectiveness of intraocular silicone oil with that of an intraocular long-acting gas (initially sulfur hexafluoride \[SF 6 \], later perfluoropropane \[C 3 F 8 \]) for the management of retinal detachment complicated by proliferative vitreoretinopathy (PVR), using vitrectomy and associated techniques. To evaluate the ocular complications that result from the use of silicone oil and gas.

Conditions

Proliferative Vitreoretinopathy; Retinal Detachment

Interventions

Perfluoropropane DRUG

Sulfur Hexafluoride DRUG

Silicone Oil DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Eligibility criteria included but were not limited to PVR of Grade C-3 or greater according to the Retina Society Classification and visual acuity of light perception or better.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Related Publications (10)

• Lean JS. Changing attitudes in United States to use of intravitreal silicone. Jpn J Ophthalmol. 1987;31(1):132-7.

  PMID: 3626172 BACKGROUND

• Glaser BM. Silicone oil for proliferative vitreoretinopathy. Does it help or hinder? Arch Ophthalmol. 1988 Mar;106(3):323-4. doi: 10.1001/archopht.1988.01060130349017. No abstract available.

  PMID: 3345147 BACKGROUND

• Azen SP, Irvine AR, Davis MD, Stern W, Lonn L, Hilton G, Schwartz A, Boone D, Quillen-Thomas B, Lyons M, et al. The validity and reliability of photographic documentation of proliferative vitreoretinopathy. Ophthalmology. 1989 Mar;96(3):352-7. doi: 10.1016/s0161-6420(89)32895-8.

  PMID: 2652029 BACKGROUND

• Boone DC; Lai M; Azen S; Silicone Study Group; Clinical judgment and centralized data management., Controlled Clin Trials 1989;10:339

  BACKGROUND

• Irvine AR; Photographic documentation and grading of PVR, in Freeman HM, Tolentino FI (eds)., Proliferative Vitreoretinopathy, New York, Springer-Verlag 1989:105-109

  BACKGROUND

• Lean JS, Stern WH, Irvine AR, Azen SP. Classification of proliferative vitreoretinopathy used in the silicone study. The Silicone Study Group. Ophthalmology. 1989 Jun;96(6):765-71. doi: 10.1016/s0161-6420(89)32821-1.

  PMID: 2662099 BACKGROUND

• Barlow W, Azen S. The effect of therapeutic treatment crossovers on the power of clinical trials. The Silicone Study Group. Control Clin Trials. 1990 Oct;11(5):314-26. doi: 10.1016/0197-2456(90)90173-y.

  PMID: 1963127 BACKGROUND

• Stern WH; Lean JS; Silicone Study Group; Intraocular silicone oil versus gas in the management of proliferative vitreoretinopathy (PVR): A multicenter clinical study, in Freeman HM, Tolentino FI (eds)., Proliferative Vitreoretinopathy, New York, Springer-Verlag 1989

  BACKGROUND

• Azen SP, Boone DC, Barlow W, McCuen BW, Walonker AF, Anderson MM, Lean JS, Mowery RL, Ryan SJ, Stern W. Methods, statistical features, and baseline results of a standardized, multicentered ophthalmologic surgical trial: the Silicone Study. Control Clin Trials. 1991 Jun;12(3):438-55. doi: 10.1016/0197-2456(91)90022-e.

  PMID: 1651213 BACKGROUND

• Schwartz SG, Flynn HW Jr, Wang X, Kuriyan AE, Abariga SA, Lee WH. Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy. Cochrane Database Syst Rev. 2020 May 13;5(5):CD006126. doi: 10.1002/14651858.CD006126.pub4.

  PMID: 32408387 DERIVED

MeSH Terms

Conditions

Vitreoretinopathy, Proliferative; Retinal Detachment

Interventions

perflutren; Sulfur Hexafluoride; Silicone Oils

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Gases; Sulfur Compounds; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 23, 1999
• First Posted: September 24, 1999
• Study Start: September 1, 1985
• Last Updated: June 24, 2005

Record last verified: 1999-10