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Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery

Primary Purpose

Retinal Detachment Rhegmatogenous

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Surgery using low viscosity silicone oil
Surgery using high viscosity silicone oil
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Detachment Rhegmatogenous focused on measuring silicone oil, emulsification, retinal detachment surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Srinagarind Hospital, Khon Kaen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

low viscosity silicone oil

high viscosity silicone oil

Arm Description

Retinal detachment surgery using low viscosity silicone oil

Retinal detachment surgery using high viscosity silicone oil

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Retina reattachment rate
Proportion of patients having retinal reattachment after surgery in each arm/group.
visual improvement
Proportion of patients having visual improvement after surgery in each arm/group

Full Information

First Posted
December 2, 2016
Last Updated
August 12, 2019
Sponsor
Khon Kaen University
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1. Study Identification

Unique Protocol Identification Number
NCT02988583
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment Rhegmatogenous
Keywords
silicone oil, emulsification, retinal detachment surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low viscosity silicone oil
Arm Type
Experimental
Arm Description
Retinal detachment surgery using low viscosity silicone oil
Arm Title
high viscosity silicone oil
Arm Type
Active Comparator
Arm Description
Retinal detachment surgery using high viscosity silicone oil
Intervention Type
Device
Intervention Name(s)
Surgery using low viscosity silicone oil
Intervention Description
Pars plans vitrectomy using low viscosity silicone oil
Intervention Type
Device
Intervention Name(s)
Surgery using high viscosity silicone oil
Intervention Description
Pars plans vitrectomy using high viscosity silicone oil
Primary Outcome Measure Information:
Title
Emulsification rate
Description
Proportion of patients developing silicone oil emulsification in each arm/group.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Retina reattachment rate
Description
Proportion of patients having retinal reattachment after surgery in each arm/group.
Time Frame
12 months
Title
visual improvement
Description
Proportion of patients having visual improvement after surgery in each arm/group
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Srinagarind Hospital, Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32408387
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.
Results Reference
derived
PubMed Identifier
32103882
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.
Results Reference
derived

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Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery

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