Retinal Detachment RhegmatogenousNCT02988583
Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery
A study testing Surgery using low viscosity silicone oil and Surgery using high viscosity silicone oil in people with Retinal Detachment Rhegmatogenous, run by Khon Kaen University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment Rhegmatogenous
- What is being tested?
- Surgery using low viscosity silicone oil and Surgery using high viscosity silicone oil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2016to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnosis of complicated retinal detachment who underwent pars plana vitrectomy with intravitreal silicone oil tamponade
- Age ≥ 18 years
- Sign informed consent form
Who cannot join
- Inflammatory eye diseases i.e. uveitis
- Corneal scar
- History of scleral buckling procedure
- History of using surfactant drugs
- Glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery: A Randomized Double-masked Clinical Trial
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.
Read the 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.
- Conditions
- Retinal Detachment Rhegmatogenous
- Being tested
- Surgery using low viscosity silicone oil, Surgery using high viscosity silicone oil
- Keywords
- silicone oil, emulsification, retinal detachment surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery using low viscosity silicone oilDevice
Pars plans vitrectomy using low viscosity silicone oil
Surgery using high viscosity silicone oilDevice
Pars plans vitrectomy using high viscosity silicone oil
| Study group | Role | What they receive |
|---|---|---|
| low viscosity silicone oil | Experimental | Retinal detachment surgery using low viscosity silicone oil Receives: Device: Surgery using low viscosity silicone oil |
| high viscosity silicone oil | Active comparator | Retinal detachment surgery using high viscosity silicone oil Receives: Device: Surgery using high viscosity silicone oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emulsification rate
Proportion of patients developing silicone oil emulsification in each arm/group.
Measured: 12 months
Secondary outcomes (2)
Retina reattachment rate
Proportion of patients having retinal reattachment after surgery in each arm/group.
Measured: 12 months
visual improvement
Proportion of patients having visual improvement after surgery in each arm/group
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Retinal Detachment RhegmatogenousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yosanan Yospaiboon, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988583
- Sponsor's protocol ID
- HE591018
- Status last verified
- Aug 2019
- First submitted
- 2 Dec 2016
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 32408387Ratanapakorn 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.
PubMed 32103882
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emulsification of Different Viscosity Silicone Oil After Complicated Retinal Detachment Surgery: A Randomized Double-masked Clinical Trial
- ClinicalTrials.gov ID
- NCT02988583
- Acronym / sponsor ID
- HE591018
- Conditions
- Retinal Detachment Rhegmatogenous
- Keywords
- silicone oil, emulsification, retinal detachment surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low viscosity silicone oil | Experimental | Device: Surgery using low viscosity silicone oilRetinal detachment surgery using low viscosity silicone oil |
| high viscosity silicone oil | Active comparator | Device: Surgery using high viscosity silicone oilRetinal detachment surgery using high viscosity silicone oil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with diagnosis of complicated retinal detachment who underwent pars plana vitrectomy with intravitreal silicone oil tamponade
- Age ≥ 18 years
- Sign informed consent form
Key exclusion criteria (5 listed)
- Inflammatory eye diseases i.e. uveitis
- Corneal scar
- History of scleral buckling procedure
- History of using surfactant drugs
- Glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery using low viscosity silicone oilPars plans vitrectomy using low viscosity silicone oil | Device | low viscosity silicone oil |
| Surgery using high viscosity silicone oilPars plans vitrectomy using high viscosity silicone oil | Device | high viscosity silicone oil |
Primary outcome
Emulsification rate
Time frame: 12 months
Proportion of patients developing silicone oil emulsification in each arm/group.
2 secondary outcomes
Retina reattachment rate
Time frame: 12 months
visual improvement
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Derived from this study: PubMed 32408387Schwartz 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.
- Derived from this study: PubMed 32103882Ratanapakorn 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery using low viscosity silicone oil and Surgery using high viscosity silicone oil in people with Retinal Detachment Rhegmatogenous, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emulsification rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02988583, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.