Epiretinal MembraneNCT03457584
Effect of Air-tamponade on Intraretinal Cystoid Changes After Membrane Peeling
A study testing air arm and BSS arm in people with Epiretinal Membrane, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
Patients with intraretinal cystoid changes before scheduled membrane peeling for epiretinal membranes are included. Patients are randomized for balanced salt solution (BSS) or air-tamponade. 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?
- air arm and BSS arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2017to 1 Dec 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
- epiretinal membranes and intraretinal cystoid changes
Who cannot join
- macular edema due to other reason than epiretinal membrane
- hereditary ocular disease
- pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site
VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital
Vienna, 1140
About this study
Official title: Effect of Air-tamponade on Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling
Patients with intraretinal cystoid changes before scheduled membrane peeling for epiretinal membranes are included. Patients are randomized for balanced salt solution (BSS) or air-tamponade.
Read the detailed description
Patients with intraretinal cystoid changes before scheduled membrane peeling for epiretinal membranes are included. 23G-pars plana vitrectomy with membrane peeling is performed in all patients. Before surgery patients are randomized for BSS or air-tamponade. Optical coherence tomography (OCT) is performed 5 days after and 3 months after surgery, visual acuity is measured 3 months after surgery.
- Conditions
- Epiretinal Membrane
- Being tested
- air arm, BSS arm
- Medical subject headings
- Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
air armProcedure or surgery
epiretinal membranes are excised during membrane peeling and air-tamponade is left in the eye
BSS armProcedure or surgery
epiretinal membranes are excised during membrane Peeling and BSS is left in the eye
| Study group | Role | What they receive |
|---|---|---|
| BSS arm | Active comparator | BSS is given at the end of surgery Receives: Procedure: BSS arm |
| air arm | Experimental | air-tamponade is given at the end of surgery Receives: Procedure: air arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
resorption of intraretinal cystoid changes after surgery
occurrence of intraretinal cystoid changes will be diagnosed by OCT
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start1 Nov 2017
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
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
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, Prof, Principal investigator, VIROS at Hanuschkrankenhaus Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457584
- Sponsor's protocol ID
- cysMP
- Status last verified
- Sep 2020
- First submitted
- 1 Mar 2018
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Air-tamponade on Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling
- ClinicalTrials.gov ID
- NCT03457584
- Acronym / sponsor ID
- cysMP
- Conditions
- Epiretinal Membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 7 Mar 2018 (actual)
- 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.
Patients with intraretinal cystoid changes before scheduled membrane peeling for epiretinal membranes are included. Patients are randomized for balanced salt solution (BSS) or air-tamponade.
Detailed description
Patients with intraretinal cystoid changes before scheduled membrane peeling for epiretinal membranes are included. 23G-pars plana vitrectomy with membrane peeling is performed in all patients. Before surgery patients are randomized for BSS or air-tamponade. Optical coherence tomography (OCT) is performed 5 days after and 3 months after surgery, visual acuity is measured 3 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BSS arm | Active comparator | Procedure: BSS armBSS is given at the end of surgery |
| air arm | Experimental | Procedure: air armair-tamponade is given at the end of surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- epiretinal membranes and intraretinal cystoid changes
Key exclusion criteria (3 listed)
- macular edema due to other reason than epiretinal membrane
- hereditary ocular disease
- pregnancy
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 |
|---|---|---|
| air armepiretinal membranes are excised during membrane peeling and air-tamponade is left in the eye | Procedure or surgery | air arm |
| BSS armepiretinal membranes are excised during membrane Peeling and BSS is left in the eye | Procedure or surgery | BSS arm |
Primary outcome
resorption of intraretinal cystoid changes after surgery
Time frame: 3 months
occurrence of intraretinal cystoid changes will be diagnosed by OCT
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 29 Sep 2020.
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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.
Oliver Findl, Prof principal investigator
VIROS at Hanuschkrankenhaus Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing air arm and BSS arm in people with Epiretinal Membrane, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
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 1 inclusion and 3 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 29 Sep 2020. 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 Austria. 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?
resorption of intraretinal cystoid changes after surgery (time frame: 3 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 29 Sep 2020.