Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
1985-09-30
Brief Summary
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To evaluate the ocular complications that result from the use of silicone oil and gas.
Detailed Description
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The Silicone Study was a randomized trial to investigate the relative merits of silicone oil or gas as tamponade modalities. All study patients underwent vitrectomy and were randomized intraoperatively either to silicone oil or to gas. Two groups of eyes were entered into the study: eyes that had not had a prior vitrectomy (Group 1) and those that had undergone previous vitrectomy outside the study (Group 2).
A critical element in the study was a standardized surgical procedure for PVR. This surgical procedure, intended to relieve retinal traction with vitrectomy techniques, was followed by assessment of the relief provided by an intraocular air tamponade. The eye was randomized to silicone oil or gas only after completion of the entire surgical procedure to eliminate investigator bias that might develop through knowledge of the treatment modality. Patients were examined 5 to 14 days following the randomization and again at 1, 3, 6, 12, 18, 24, and 36 months after that date. Repeated surgery was permitted for either treatment modality. The Fundus Photograph Reading Center staff processed and analyzed photographs taken at all the clinics, graded the preoperative severity of PVR on the basis of baseline visit photographs, and confirmed the macular status at followup visits.
End points of the study were visual acuity of 5/200 or greater and macular reattachment for 6 months following the final surgical procedure. The successful outcomes and complication rates of the two modalities were compared.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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Perfluoropropane
Sulfur Hexafluoride
Silicone Oil
Eligibility Criteria
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Inclusion Criteria
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
References
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Lean JS. Changing attitudes in United States to use of intravitreal silicone. Jpn J Ophthalmol. 1987;31(1):132-7.
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.
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.
Boone DC; Lai M; Azen S; Silicone Study Group; Clinical judgment and centralized data management., Controlled Clin Trials 1989;10:339
Irvine AR; Photographic documentation and grading of PVR, in Freeman HM, Tolentino FI (eds)., Proliferative Vitreoretinopathy, New York, Springer-Verlag 1989:105-109
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.
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.
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
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.
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.
Other Identifiers
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NEI-39
Identifier Type: -
Identifier Source: org_study_id