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NCT Number: NCT02988583

Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery

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.

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Key information

Conditions

Retinal Detachment Rhegmatogenous

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Srinagarind Hospital, Khon Kaen University

Khon Kaen, 40002, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery using low viscosity silicone oil

Device

Pars plans vitrectomy using low viscosity silicone oil

Surgery using high viscosity silicone oil

Device

Pars plans vitrectomy using high viscosity silicone oil

Primary outcomes

  1. Emulsification rate

    Time frame: 12 months

    Proportion of patients developing silicone oil emulsification in each arm/group.

Secondary outcomes

  1. Retina reattachment rate

    Time frame: 12 months

    Proportion of patients having retinal reattachment after surgery in each arm/group.

  2. visual improvement

    Time frame: 12 months

    Proportion of patients having visual improvement after surgery in each arm/group

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 9, 2016
Registry last updated
Aug 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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