NCT02988583

Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery

Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery: A Randomized Double-masked Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Khon Kaen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Silicone oil has been used as a surgical tool in complicated retinal detachment surgery. There are some complications occurring in pars plana vitrectomy with silicone oil tamponade. Silicone oil emulsification is one of the complication that may result in severe sequels that are difficult to treat. It is believed that low viscosity silicone oil has more risk to develop emulsification than high viscosity silicone oil. Up to now, however, there is no conclusive guideline that which types of silicone oil is suitable for these complicated retinal detachment surgeries and what is the appropriate time to remove the oil. This prospective study aims to study the silicone oil emulsification comparing between low viscosity and high viscosity silicone oil after complicated retinal detachment surgery.

Detailed description

Silicone oil has been used as a surgical tool in retinal detachment surgery since 1962. The National Eye Institute Silicone Study demonstrated the superiority of silicone oil compared with sulfur hexafluoride, and its comparability with perfluoropropane, for the treatment of complicated retinal detachment associated with advanced proliferative vitreoretinopathy. There are some complications occurring in pars plana vitrectomy with silicone oil tamponade. These complications may occur during surgery and after the surgery. Silicone oil emulsification is one of the complication that may result in severe sequels including band-shaped keratopathy, complicated glaucoma and retinopathy that are difficult to treat. The commonly used silicone oil includes low viscosity and high viscosity type. It is believed that low viscosity silicone oil has more risk to develop emulsification than high viscosity silicone oil. Up to now, however, there is no conclusive guideline that which types of silicone oil is suitable for these complicated retinal detachment surgeries and what is the appropriate time to remove the oil. Retrospective medical review of these patients using 1000-vs 5000-centistoke silicone oil demonstrated that anatomic and visual acuity outcomes, as well as complication rates including emulsification, were similar in both groups. To the best of authors' knowledge, there has been no prospective study on this subject. This study aims to study the silicone oil emulsification comparing between low viscosity and high viscosity silicone oil after complicated retinal detachment surgery.

Conditions

• Retinal Detachment Rhegmatogenous

Interventions

Type	Name	Description
DEVICE	Surgery using low viscosity silicone oil	Pars plans vitrectomy using low viscosity silicone oil
DEVICE	Surgery using high viscosity silicone oil	Pars plans vitrectomy using high viscosity silicone oil

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2016-12-09
• Last updated: 2019-08-14

Locations

1 site across 1 country: Thailand