Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery

Khon Kaen University

Status: Completed

Conditions: Retinal Detachment Rhegmatogenous

Treatments: Device: Surgery using high viscosity silicone oil; Device: Surgery using low viscosity silicone oil

Study type: Interventional

Funder types: Other

Identifiers

NCT02988583

HE591018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

low viscosity silicone oil

Experimental group

Description:

Retinal detachment surgery using low viscosity silicone oil

Treatment:

Device: Surgery using low viscosity silicone oil

high viscosity silicone oil

Active Comparator group

Description:

Retinal detachment surgery using high viscosity silicone oil

Treatment:

Device: Surgery using high viscosity silicone oil