Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery

Retinal Detachment Rhegmatogenous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02988583
• Other study ID #: HE591018
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: August 2019

Study information

• Verified date: August 2019
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment
• Retinal Detachment Rhegmatogenous

Intervention

Device:
• Surgery using low viscosity silicone oil
Pars plans vitrectomy using low viscosity silicone oil
• Surgery using high viscosity silicone oil
Pars plans vitrectomy using high viscosity silicone oil

Locations

Country	Name	City	State
Thailand	Srinagarind Hospital, Khon Kaen University	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emulsification rate	Proportion of patients developing silicone oil emulsification in each arm/group.	12 months
Secondary	Retina reattachment rate	Proportion of patients having retinal reattachment after surgery in each arm/group.	12 months
Secondary	visual improvement	Proportion of patients having visual improvement after surgery in each arm/group	12 months