Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery

Not Applicable

Completed

• Conditions: Retinal Detachment Rhegmatogenous
• Interventions: Device: Surgery using low viscosity silicone oil; Device: Surgery using high viscosity silicone oil

• Registration Number: NCT02988583
• Lead Sponsor: Khon Kaen University

Brief 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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2016-12-07
• Study First Posted: 2016-12-09
• Status Verified: 2019-08
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with diagnosis of complicated retinal detachment who underwent pars plana vitrectomy with intravitreal silicone oil tamponade
• Age ≥ 18 years
• Sign informed consent form

Exclusion Criteria

• Inflammatory eye diseases i.e. uveitis
• Corneal scar
• History of scleral buckling procedure
• History of using surfactant drugs
• Glaucoma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low viscosity silicone oil	Surgery using low viscosity silicone oil	Retinal detachment surgery using low viscosity silicone oil
high viscosity silicone oil	Surgery using high viscosity silicone oil	Retinal detachment surgery using high viscosity silicone oil

Primary Outcome Measures

Name	Time	Method
Emulsification rate	12 months	Proportion of patients developing silicone oil emulsification in each arm/group.

Secondary Outcome Measures

Name	Time	Method
Retina reattachment rate	12 months	Proportion of patients having retinal reattachment after surgery in each arm/group.
visual improvement	12 months	Proportion of patients having visual improvement after surgery in each arm/group

Trial Locations

Locations (1)

Srinagarind Hospital, Khon Kaen University; 🇹🇭 Khon Kaen, Thailand