NCT02988583

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

2.8 years

First QC Date

December 2, 2016

Last Update Submit

August 12, 2019

Conditions

Retinal Detachment Rhegmatogenous

Keywords

silicone oilemulsificationretinal detachment surgery

Outcome Measures

Primary Outcomes (1)

  • Emulsification rate

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

    12 months

Secondary Outcomes (2)

  • Retina reattachment rate

    12 months

  • visual improvement

    12 months

Study Arms (2)

low viscosity silicone oil

EXPERIMENTAL

Retinal detachment surgery using low viscosity silicone oil

Device: Surgery using low viscosity silicone oil

high viscosity silicone oil

ACTIVE COMPARATOR

Retinal detachment surgery using high viscosity silicone oil

Device: Surgery using high viscosity silicone oil

Interventions

Surgery using low viscosity silicone oilDEVICE

Pars plans vitrectomy using low viscosity silicone oil

low viscosity silicone oil
Surgery using high viscosity silicone oilDEVICE

Pars plans vitrectomy using high viscosity silicone oil

high viscosity silicone oil

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with diagnosis of complicated retinal detachment who underwent pars plana vitrectomy with intravitreal silicone oil tamponade
  • Age ≥ 18 years
  • Sign informed consent form

You may not qualify if:

  • Inflammatory eye diseases i.e. uveitis
  • Corneal scar
  • History of scleral buckling procedure
  • History of using surfactant drugs
  • Glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Srinagarind Hospital, Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Related Publications (2)

  • 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.

    PMID: 32408387DERIVED

  • 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.

    PMID: 32103882DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 2, 2016

First Posted

December 9, 2016

Study Start

October 1, 2016

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

August 14, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)