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Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery

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ClinicalTrials.gov Identifier: NCT02988583
Recruitment Status : Completed
First Posted : December 9, 2016
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Yosanan Yospaiboon, 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.

Condition or disease Intervention/treatment Phase
Retinal Detachment Rhegmatogenous Device: Surgery using low viscosity silicone oil Device: Surgery using high viscosity silicone oil Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery: A Randomized Double-masked Clinical Trial
Actual Study Start Date : October 2016
Actual Primary Completion Date : August 2019
Actual Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: low viscosity silicone oil
Retinal detachment surgery using low viscosity silicone oil
Device: Surgery using low viscosity silicone oil
Pars plans vitrectomy using low viscosity silicone oil

Active Comparator: high viscosity silicone oil
Retinal detachment surgery using high viscosity silicone oil
Device: Surgery using high viscosity silicone oil
Pars plans vitrectomy using high viscosity silicone oil




Primary Outcome Measures :
  1. Emulsification rate [ Time Frame: 12 months ]
    Proportion of patients developing silicone oil emulsification in each arm/group.


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988583


Locations
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Thailand
Srinagarind Hospital, Khon Kaen University
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University

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Responsible Party: Yosanan Yospaiboon, Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT02988583    
Other Study ID Numbers: HE591018
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yosanan Yospaiboon, Khon Kaen University:
silicone oil
emulsification
retinal detachment surgery
Additional relevant MeSH terms:
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Retinal Detachment
Dissociative Disorders
Mental Disorders
Retinal Diseases
Eye Diseases