Epiretinal MembraneNCT02030262
Study of Impact of Air vs SF6 20% on Visual Acuity Improvement After Epiretinal Membrane Stripping
A study testing Epiretinal membrane peeling with fluid-air exchange and Epiretinal membrane peeling with fluid-SF6 exchange in people with Epiretinal Membrane, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
The purpose of this study is to determine if one of these gaz (air and sulfur hexafluoride) is better than the other in epiretinal membrane peeling surgery. Both are already used for this surgery and this study will tell us if one is better than the other. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epiretinal Membrane
- What is being tested?
- Epiretinal membrane peeling with fluid-air exchange and Epiretinal membrane peeling with fluid-SF6 exchange
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Feb 2016
- 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
- Clinical diagnosis of epiretinal membrane with corresponding optical coherence tomography
- ETDRS visual acuity worse or equal to 20/30
- Adult able to give consent
Who cannot join
- Diagnosis of age-related macular degeneration
- Opacity blocking the fundus visualisation
- Presence of active intraocular inflammation
- Presence of intraocular tumor
- Presence of retinal detachment
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
Québec, Quebec, G1S 4L8
About this study
Official title: Study of the Impact of Air Versus SF6 20% on Visual Acuity Improvement After Epiretinal Membrane Stripping
The purpose of this study is to determine if one of these gaz (air and sulfur hexafluoride) is better than the other in epiretinal membrane peeling surgery. Both are already used for this surgery and this study will tell us if one is better than the other.
- Conditions
- Epiretinal Membrane
- Being tested
- Epiretinal membrane peeling with fluid-air exchange, Epiretinal membrane peeling with fluid-SF6 exchange
- Medical subject headings
- Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epiretinal membrane peeling with fluid-air exchangeProcedure or surgery
The intervention starts with a pars plana vitrectomy and then a epiretinal membrane peeling is performed. During the fluid-gaz exchange, the gaz used will be air. The remaining of the intervention is the same between the two arms.
Epiretinal membrane peeling with fluid-SF6 exchangeProcedure or surgery
The intervention starts with a pars plana vitrectomy and then a epiretinal membrane peeling is performed. During the fluid-gaz exchange, the gaz used will be SF6 (sulfur hexafluoride). The remaining of the intervention is the same between the two arms.
| Study group | Role | What they receive |
|---|---|---|
| Air | Experimental | The participant will undergo epiretinal membrane peeling with fluid-air exchange. The remaining of the surgery is the same in all arms. Receives: Procedure: Epiretinal membrane peeling with fluid-air exchange |
| Sulfur hexafluoride (SF6) | Active comparator | The participant will undergo epiretinal membrane peeling with fluid-SF6 exchange. The remaining of the surgery will stay the same. Receives: Procedure: Epiretinal membrane peeling with fluid-SF6 exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epiretinal MembraneStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu Caissie, MD, FRCSC, Principal investigator, Centre de recherche du CHU de Québec; Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030262
- Sponsor's protocol ID
- C13-10-1231
- Status last verified
- Mar 2016
- First submitted
- 7 Jan 2014
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Air Versus SF6 20% on Visual Acuity Improvement After Epiretinal Membrane Stripping
- ClinicalTrials.gov ID
- NCT02030262
- Acronym / sponsor ID
- C13-10-1231
- Conditions
- Epiretinal Membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Jan 2014 (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.
The purpose of this study is to determine if one of these gaz (air and sulfur hexafluoride) is better than the other in epiretinal membrane peeling surgery. Both are already used for this surgery and this study will tell us if one is better than the other.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air | Experimental | Procedure: Epiretinal membrane peeling with fluid-air exchangeThe participant will undergo epiretinal membrane peeling with fluid-air exchange. The remaining of the surgery is the same in all arms. |
| Sulfur hexafluoride (SF6) | Active comparator | Procedure: Epiretinal membrane peeling with fluid-SF6 exchangeThe participant will undergo epiretinal membrane peeling with fluid-SF6 exchange. The remaining of the surgery will stay the same. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of epiretinal membrane with corresponding optical coherence tomography
- ETDRS visual acuity worse or equal to 20/30
- Adult able to give consent
Key exclusion criteria (5 listed)
- Diagnosis of age-related macular degeneration
- Opacity blocking the fundus visualisation
- Presence of active intraocular inflammation
- Presence of intraocular tumor
- Presence of retinal detachment
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 |
|---|---|---|
| Epiretinal membrane peeling with fluid-air exchangeThe intervention starts with a pars plana vitrectomy and then a epiretinal membrane peeling is performed. During the fluid-gaz exchange, the gaz used will be air. The remaining of the intervention is the same between the two arms. | Procedure or surgery | Air |
| Epiretinal membrane peeling with fluid-SF6 exchangeThe intervention starts with a pars plana vitrectomy and then a epiretinal membrane peeling is performed. During the fluid-gaz exchange, the gaz used will be SF6 (sulfur hexafluoride). The remaining of the intervention is the same between the two arms. | Procedure or surgery | Sulfur hexafluoride (SF6) |
Primary outcome
Visual acuity
Time frame: 6 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 8 Mar 2016.
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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.
Mathieu Caissie, MD, FRCSC principal investigator
Centre de recherche du CHU de Québec; Université Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epiretinal membrane peeling with fluid-air exchange and Epiretinal membrane peeling with fluid-SF6 exchange in people with Epiretinal Membrane, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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 8 Mar 2016. 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 Canada. 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?
Visual acuity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2016.