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The Silicone Study

Primary Purpose

Proliferative Vitreoretinopathy, Retinal Detachment

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Perfluoropropane
Sulfur Hexafluoride
Silicone Oil
Sponsored by
National Eye Institute (NEI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proliferative Vitreoretinopathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 23, 1999
    Last Updated
    June 23, 2005
    Sponsor
    National Eye Institute (NEI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000140
    Brief Title
    The Silicone Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 1999
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1985 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Eye Institute (NEI)

    4. Oversight

    5. Study Description

    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.
    Detailed Description
    The treatment of retinal detachment complicated by PVR remains controversial. Although some cases are managed successfully by pars plana vitrectomy and with temporary tamponade provided by intraocular gas, others eventually redetach with this technique. Preliminary reports indicate that prolonged tamponade with liquid silicone results in improved anatomical success, but the eventual visual outcome may be prejudiced by silicone-related complications, particularly glaucoma and keratopathy. The addition of hydraulic reattachment by simultaneous fluid/gas exchange to vitrectomy surgery has proved to be an important development. Although complications are few with these procedures, subsequent redetachment is frequent. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Proliferative Vitreoretinopathy, Retinal Detachment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Perfluoropropane
    Intervention Type
    Drug
    Intervention Name(s)
    Sulfur Hexafluoride
    Intervention Type
    Drug
    Intervention Name(s)
    Silicone Oil

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    3626172
    Citation
    Lean JS. Changing attitudes in United States to use of intravitreal silicone. Jpn J Ophthalmol. 1987;31(1):132-7.
    Results Reference
    background
    PubMed Identifier
    3345147
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    2652029
    Citation
    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.
    Results Reference
    background
    Citation
    Boone DC; Lai M; Azen S; Silicone Study Group; Clinical judgment and centralized data management., Controlled Clin Trials 1989;10:339
    Results Reference
    background
    Citation
    Irvine AR; Photographic documentation and grading of PVR, in Freeman HM, Tolentino FI (eds)., Proliferative Vitreoretinopathy, New York, Springer-Verlag 1989:105-109
    Results Reference
    background
    PubMed Identifier
    2662099
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    1963127
    Citation
    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.
    Results Reference
    background
    Citation
    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
    Results Reference
    background
    PubMed Identifier
    1651213
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32408387
    Citation
    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.
    Results Reference
    derived

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    The Silicone Study

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