Retinal Detachment Rhegmatogenous
Conditions
Keywords
silicone oil, emulsification, retinal detachment surgery
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.
Interventions
DEVICESurgery using low viscosity silicone oil
Pars plans vitrectomy using low viscosity silicone oil
DEVICESurgery using high viscosity silicone oil
Pars plans vitrectomy using high viscosity silicone oil
Sponsors
Khon Kaen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emulsification rate | 12 months | Proportion of patients developing silicone oil emulsification in each arm/group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Thailand
Outcome results
None listed