Clinical trial NCT02988583: Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery
Official title: Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery: A Randomized Double-masked Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Detachment Rhegmatogenous
Keywords: silicone oil
emulsification
retinal detachment surgery
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Emulsification rate
timeFrame: 12 months
Secondary outcomes:
measure: Retina reattachment rate
timeFrame: 12 months
measure: visual improvement
timeFrame: 12 months
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital, Khon Kaen University
Study officials:
References:
citation: Schwartz SG, Flynn HW Jr, Wang X, Kuriyan AE, Abariga SA, Lee WH. Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy. Cochrane Database Syst Rev. 2020 May 13;5(5):CD006126. doi: 10.1002/14651858.CD006126.pub4.
citation: Ratanapakorn T, Thongmee W, Meethongkam K, Sinawat S, Sanguansak T, Bhoomibunchoo C, Laovirojjanakul W, Yospaiboon Y. Emulsification of Different Viscosity Silicone Oil in Complicated Retinal Detachment Surgery: A Randomized Double-Blinded Clinical Trial. Clin Ophthalmol. 2020 Feb 7;14:359-367. doi: 10.2147/OPTH.S242804. eCollection 2020.