Dexamethasone Intravitreal Implant After Vitrectomy For Epiretinal Membrane
NCT ID: NCT01410201
Last Updated: 2016-07-27
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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TERMINATED
NA
6 participants
INTERVENTIONAL
2011-08-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PPV + MP + DEX
Patients will undergo pars plana vitrectomy, membrane peel, and concomitant Ozurdex implant (0.7 mg dose).
Dexamethasone Intravitreal Implant
Half of the study participants (15 out of 30) will receive one - Dexamethasone Intravitreal Implant 0.7 mg.
PPV + MP
Patients will undergo pars plana vitrectomy with membrane peel, without Ozurdex implant.
Dexamethasone Intravitreal Implant
Half of the study participants (15 out of 30) will receive one - Dexamethasone Intravitreal Implant 0.7 mg.
Interventions
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Dexamethasone Intravitreal Implant
Half of the study participants (15 out of 30) will receive one - Dexamethasone Intravitreal Implant 0.7 mg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Preoperative visual acuity of snellen equivalent 20/32 or worse
Exclusion Criteria
* uveitis
* macular hole
* previous vitreoretinal surgery
* any other retinal pathology that could affect anatomic or functional results
* Age Related Macular Degeneration
* Diabetic Retinopathy
* Diabetic Macular Edema
* Retinal Vein Occlusion
* Pre-existing Macular Disease
ALL
No
Sponsors
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Allergan
INDUSTRY
Barnes Retina Institute
OTHER
Responsible Party
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Rhonda Weeks
Gaurav K. Shah, MD
Principal Investigators
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Gaurav K Shah, MD
Role: PRINCIPAL_INVESTIGATOR
Retina Institute
Locations
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St. Lukes Hospital
Chesterfield, Missouri, United States
St. Louis Eye Surgery and Laser Center
St Louis, Missouri, United States
The Retina Institute
St Louis, Missouri, United States
Countries
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References
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Smiddy WE, Michels RG, Green WR. Morphology, pathology, and surgery of idiopathic vitreoretinal macular disorders. A review. Retina. 1990;10(4):288-96. doi: 10.1097/00006982-199010000-00012.
de Bustros S, Thompson JT, Michels RG, Rice TA, Glaser BM. Vitrectomy for idiopathic epiretinal membranes causing macular pucker. Br J Ophthalmol. 1988 Sep;72(9):692-5. doi: 10.1136/bjo.72.9.692.
Michels RG. Vitrectomy for macular pucker. Ophthalmology. 1984 Nov;91(11):1384-8. doi: 10.1016/s0161-6420(84)34136-7.
McDonald HR, Verre WP, Aaberg TM. Surgical management of idiopathic epiretinal membranes. Ophthalmology. 1986 Jul;93(7):978-83. doi: 10.1016/s0161-6420(86)33635-2.
Schadlu R, Tehrani S, Shah GK, Prasad AG. Long-term follow-up results of ilm peeling during vitrectomy surgery for premacular fibrosis. Retina. 2008 Jun;28(6):853-7. doi: 10.1097/IAE.0b013e3181631962.
Koerner F, Garweg J. Vitrectomy for macular pucker and vitreomacular traction syndrome. Doc Ophthalmol. 1999;97(3-4):449-58. doi: 10.1023/a:1002412323399.
Massin P, Allouch C, Haouchine B, Metge F, Paques M, Tangui L, Erginay A, Gaudric A. Optical coherence tomography of idiopathic macular epiretinal membranes before and after surgery. Am J Ophthalmol. 2000 Dec;130(6):732-9. doi: 10.1016/s0002-9394(00)00574-2.
Konstantinidis L, Berguiga M, Beknazar E, Wolfensberger TJ. Anatomic and functional outcome after 23-gauge vitrectomy, peeling, and intravitreal triamcinolone for idiopathic macular epiretinal membrane. Retina. 2009 Sep;29(8):1119-27. doi: 10.1097/IAE.0b013e3181ac23da.
Kosobucki BR, Freeman WR, Cheng L. Photographic estimation of the duration of high dose intravitreal triamcinolone in the vitrectomised eye. Br J Ophthalmol. 2006 Jun;90(6):705-8. doi: 10.1136/bjo.2005.088278. Epub 2006 Mar 10.
Other Identifiers
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OZURDEX ERM
Identifier Type: -
Identifier Source: org_study_id
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