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

Sponsors

Lead Sponsor: Khon Kaen University

Source 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.

Overall Status Completed
Start Date October 2016
Completion Date August 2019
Primary Completion Date August 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Emulsification rate 12 months
Secondary Outcome
Measure Time Frame
Retina reattachment rate 12 months
visual improvement 12 months
Enrollment 100
Condition
Intervention

Intervention Type: Device

Intervention Name: Surgery using low viscosity silicone oil

Description: Pars plans vitrectomy using low viscosity silicone oil

Arm Group Label: low viscosity silicone oil

Intervention Type: Device

Intervention Name: Surgery using high viscosity silicone oil

Description: Pars plans vitrectomy using high viscosity silicone oil

Arm Group Label: high viscosity silicone oil

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility: Srinagarind Hospital, Khon Kaen University
Location Countries

Thailand

Verification Date

August 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Khon Kaen University

Investigator Full Name: Yosanan Yospaiboon

Investigator Title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: low viscosity silicone oil

Type: Experimental

Description: Retinal detachment surgery using low viscosity silicone oil

Label: high viscosity silicone oil

Type: Active Comparator

Description: Retinal detachment surgery using high viscosity silicone oil

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov