HSO Study |
Study name |
The Heavy Silicone Oil versus Standard Silicone Oil Study (HSO) |
Methods |
Randomized controlled trial to determine safety and efficacy of vitrectomy with two types of endotamponades |
Participants |
Multicenter study enrolling patients with inferior and posterior PVR grade C-A6, P12 according to Machemer or inferior detachment with giant retinal tear in the inferior hemisphere |
Interventions |
Two-arm parallel group design:
Heavy silicone oil (endotamponade with heavy silicone oil)
Standard silicone oil (endotamponade with silicone oil of viscosity: 1000 or 5000 cSt)
|
Outcomes |
Main endpoints: Complete retinal attachment at 12 months and change of visual acuity at 12 months postoperatively |
Secondary endpoints: Complete retinal attachment before endotamponade removal, quality of life analysis, and the evaluation of the number of retina affecting re-operation within 1 year of follow-up |
Other endpoints: Emulsification of the compound, cataract formation, number of eyes with constantly raised intraocular pressure from baseline, and the number of eyes with glaucoma |
Starting date |
January 2004 |
Contact information |
Antonia M Joussen, Department of Ophthalmology, University of Düsseldorf, Moorenstrasse 5, Düsseldorf, Germany; |
Notes |
The present article describes the methods and design. The investigators have not published results. |