Epiretinal MembraneNCT02319655
Morphologic Changes After Membrane Peeling With Air Tamponade and Balanced Salt Solution
A study testing Air tamponade and Balanced salt solution filling in people with Epiretinal Membrane and Macular Pucker, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
Trial summary
During the last decade optical coherence tomography (OCT) extended the possibilities for in vivo macula diagnostic and was increasingly used for pre- and post-operative imaging of retinal diseases. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Epiretinal Membrane, Macular Pucker
- What is being tested?
- Air tamponade and Balanced salt solution filling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2014to Sep 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Epiretinal membrane and the indication for surgery (visual symptoms)
- Age 21 and older
- written informed consent prior to surgery
Who cannot join
- Patients who have already undergone vitrectomy
- In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes of the Subfoveal Hyporeflective Zone After Membrane Peeling With Air Tamponade and Balanced Salt Solution - a Pilot Study
During the last decade optical coherence tomography (OCT) extended the possibilities for in vivo macula diagnostic and was increasingly used for pre- and post-operative imaging of retinal diseases. Spectral-domain optical coherence tomography (SD-OCT) with its increased scanning speed and image-resolution provides more detailed information of microstructures in the macula. Epiretinal membrane (ERM) is a disorder involving the posterior pole of the eyeball. It can be idiopathic or caused secondarily in various ocular conditions, such as uveitis, trauma, retinal detachment or retinal vascular diseases. In patients who suffer from loss of vision and metamorphopsia, vitrectomy and membrane peeling is usually performed to remove the ERM.
Different study groups showed that intraoperative use of SD-OCT is possible. Two groups already achieved to work operation microscope integrated SD-OCT setup. Due to the high axial resolution of the SD-OCT some groups reported about an increased hyporeflective zone in the subfoveal region appearing directly after the membrane peeling procedure. It was hypothesized that this phenomenon could be an expression of surgical trauma, as this hyporeflective zone disappears in follow up OCT 10 days after surgery.
Read the detailed description
During the last decade optical coherence tomography (OCT) extended the possibilities for in vivo macula diagnostic and was increasingly used for pre- and post-operative imaging of retinal diseases. Spectral-domain optical coherence tomography (SD-OCT) with its increased scanning speed and image-resolution provides more detailed information of microstructures in the macula. Epiretinal membrane (ERM) is a disorder involving the posterior pole of the eyeball. It can be idiopathic or caused secondarily in various ocular conditions, such as uveitis, trauma, retinal detachment or retinal vascular diseases. In patients who suffer from loss of vision and metamorphopsia, vitrectomy and membrane peeling is usually performed to remove the ERM.
Different study groups showed that intraoperative use of SD-OCT is possible. Two groups already achieved to work operation microscope integrated SD-OCT setup. Due to the high axial resolution of the SD-OCT some groups reported about an increased hyporeflective zone in the subfoveal region appearing directly after the membrane peeling procedure. It was hypothesized that this phenomenon could be an expression of surgical trauma, as this hyporeflective zone disappears in follow up OCT 10 days after surgery .
The aim of the study is to use a microscope integrated SD-OCT in order to measure the surgically induced hyporeflective zone in the subfoveal region during membrane peeling and to evaluate whether the hyporeflective zone, that is believed to be an expression of tissue trauma, disappears faster with air tamponade compared to eyes with balanced saline solution (BSS).
Both, intraocular air tamponade and BSS are commonly used after vitrectomy with membrane peeling and pose the standard of care for this operation and no information concerning the superiority of one method is available. The non-contact microscope integrated SD-OCT, does not require any relevant additional time during the operation procedure (max. 2 minutes per operation for the OCT scans). During the OCT measurement time the light of the microscope will be reduced to a minimum to avoid additional light exposure. The OCT scans will be performed only at different time points (as mentioned below) to keep the OCT light exposure low and far below the acceptable exposure time as mentioned in the OCT safety guidelines.
SD-OCT is a safe and commonly used diagnostic tool in ophthalmology and its application does not bear any additional risk for the patients included in the study. Furthermore, all devices used in this study are CE-marked (Communauté Européenne).
Patients included in this study will not have a direct benefit from participation. However, it is very likely that the evaluation of the hyporeflective zone is the main indicator for the postoperative visual quality of a patient and this study will help to clarify, if air, or BSS have a protective effect for the fovea. In consequence, this study should help to use an intra-operative treatment that leads to a faster visual rehabilitation after membrane peeling.
- Conditions
- Epiretinal Membrane, Macular Pucker
- Being tested
- Air tamponade, Balanced salt solution filling
- Keywords
- Epiretinal membrane, Macular pucker, Membrane peeling, pars plana vitrectomy, Air, balanced salt solution, Intraoperative OCT, Hyporeflectivity, Retina
- 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 tamponadeProcedure or surgery
Air tamponade
Balanced salt solution fillingProcedure or surgery
BSS filling
| Study group | Role | What they receive |
|---|---|---|
| Air tamponade | Active comparator | Air is injected after vitrectomy/membrane peeling Receives: Procedure: Air tamponade |
| Balanced salt solution filling | Active comparator | Balances salt solution is injected after vitrectomy/membrane peeling Receives: Procedure: Balanced salt solution filling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eyes with presence of a hyporeflective zone on the 7th postoperative day on OCT scan
An expert in the field of reading retinal OCT scans will assess whether or not a hyporeflective zone on the 7th postoperative day is visible on the OCT scan
Measured: 7 days postoperatively
Secondary outcomes (3)
Change in retinal thickness 3 months after surgery assessed with OCT
Central retinal thickness assessed with OCT (µm)
Measured: 3 months
Attachment of the posterior hyaloid membrane before starting surgery assessed with intraoperative OCT
An expert in the field of reading retinal OCT scans will assess intraoperative OCT scans and determine whether or not the posterior hyaloid membrane is attached to the retina before initiation of the surgery.
Measured: intraoperatively
Best corrected visual acuity
ETDRS (Early treatment of diabetic retinopathy study) reading charts will be used to assess best corrected visual acuity
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2016
- Study completionSep 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
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, MD,Prof,MBA, Principal investigator, VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna, Vienna, Austria 1140
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319655
- Sponsor's protocol ID
- MP
- Other IDs
- EK-14-013-0214
- Status last verified
- Oct 2017
- First submitted
- 2 Jun 2014
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of the Subfoveal Hyporeflective Zone After Membrane Peeling With Air Tamponade and Balanced Salt Solution - a Pilot Study
- ClinicalTrials.gov ID
- NCT02319655
- Acronym / sponsor ID
- MP
- Conditions
- Epiretinal Membrane, Macular Pucker
- Keywords
- Epiretinal membrane, Macular pucker, Membrane peeling, pars plana vitrectomy, Air, balanced salt solution, Intraoperative OCT, Hyporeflectivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBAUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 18 Dec 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.
During the last decade optical coherence tomography (OCT) extended the possibilities for in vivo macula diagnostic and was increasingly used for pre- and post-operative imaging of retinal diseases. Spectral-domain optical coherence tomography (SD-OCT) with its increased scanning speed and image-resolution provides more detailed information of microstructures in the macula. Epiretinal membrane (ERM) is a disorder involving the posterior pole of the eyeball. It can be idiopathic or caused secondarily in various ocular conditions, such as uveitis, trauma, retinal detachment or retinal vascular diseases. In patients who suffer from loss of vision and metamorphopsia, vitrectomy and membrane peeling is usually performed to remove the ERM.
Different study groups showed that intraoperative use of SD-OCT is possible. Two groups already achieved to work operation microscope integrated SD-OCT setup. Due to the high axial resolution of the SD-OCT some groups reported about an increased hyporeflective zone in the subfoveal region appearing directly after the membrane peeling procedure. It was hypothesized that this phenomenon could be an expression of surgical trauma, as this hyporeflective zone disappears in follow up OCT 10 days after surgery.
Detailed description
During the last decade optical coherence tomography (OCT) extended the possibilities for in vivo macula diagnostic and was increasingly used for pre- and post-operative imaging of retinal diseases. Spectral-domain optical coherence tomography (SD-OCT) with its increased scanning speed and image-resolution provides more detailed information of microstructures in the macula. Epiretinal membrane (ERM) is a disorder involving the posterior pole of the eyeball. It can be idiopathic or caused secondarily in various ocular conditions, such as uveitis, trauma, retinal detachment or retinal vascular diseases. In patients who suffer from loss of vision and metamorphopsia, vitrectomy and membrane peeling is usually performed to remove the ERM.
Different study groups showed that intraoperative use of SD-OCT is possible. Two groups already achieved to work operation microscope integrated SD-OCT setup. Due to the high axial resolution of the SD-OCT some groups reported about an increased hyporeflective zone in the subfoveal region appearing directly after the membrane peeling procedure. It was hypothesized that this phenomenon could be an expression of surgical trauma, as this hyporeflective zone disappears in follow up OCT 10 days after surgery .
The aim of the study is to use a microscope integrated SD-OCT in order to measure the surgically induced hyporeflective zone in the subfoveal region during membrane peeling and to evaluate whether the hyporeflective zone, that is believed to be an expression of tissue trauma, disappears faster with air tamponade compared to eyes with balanced saline solution (BSS).
Both, intraocular air tamponade and BSS are commonly used after vitrectomy with membrane peeling and pose the standard of care for this operation and no information concerning the superiority of one method is available. The non-contact microscope integrated SD-OCT, does not require any relevant additional time during the operation procedure (max. 2 minutes per operation for the OCT scans). During the OCT measurement time the light of the microscope will be reduced to a minimum to avoid additional light exposure. The OCT scans will be performed only at different time points (as mentioned below) to keep the OCT light exposure low and far below the acceptable exposure time as mentioned in the OCT safety guidelines.
SD-OCT is a safe and commonly used diagnostic tool in ophthalmology and its application does not bear any additional risk for the patients included in the study. Furthermore, all devices used in this study are CE-marked (Communauté Européenne).
Patients included in this study will not have a direct benefit from participation. However, it is very likely that the evaluation of the hyporeflective zone is the main indicator for the postoperative visual quality of a patient and this study will help to clarify, if air, or BSS have a protective effect for the fovea. In consequence, this study should help to use an intra-operative treatment that leads to a faster visual rehabilitation after membrane peeling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air tamponade | Active comparator | Procedure: Air tamponadeAir is injected after vitrectomy/membrane peeling |
| Balanced salt solution filling | Active comparator | Procedure: Balanced salt solution fillingBalances salt solution is injected after vitrectomy/membrane peeling |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Epiretinal membrane and the indication for surgery (visual symptoms)
- Age 21 and older
- written informed consent prior to surgery
Key exclusion criteria (2 listed)
- Patients who have already undergone vitrectomy
- In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
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 tamponadeAir tamponade | Procedure or surgery | Air tamponade |
| Balanced salt solution fillingBSS filling | Procedure or surgery | Balanced salt solution filling |
Primary outcome
Proportion of eyes with presence of a hyporeflective zone on the 7th postoperative day on OCT scan
Time frame: 7 days postoperatively
An expert in the field of reading retinal OCT scans will assess whether or not a hyporeflective zone on the 7th postoperative day is visible on the OCT scan
3 secondary outcomes
Change in retinal thickness 3 months after surgery assessed with OCT
Time frame: 3 months
Attachment of the posterior hyaloid membrane before starting surgery assessed with intraoperative OCT
Time frame: intraoperatively
Best corrected visual acuity
Time frame: 3 months postoperatively
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 31 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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, MD,Prof,MBA principal investigator
VIROS - Vienna Institute for Research in Ocular Surgers - Departement of Opthalmology - Hanusch Hospital Vienna, Vienna, Austria 1140
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 tamponade and Balanced salt solution filling in people with Epiretinal Membrane and Macular Pucker, run by Prim. Prof. Dr. Oliver Findl, MBA 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 3 inclusion and 2 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 31 Oct 2017. 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?
Proportion of eyes with presence of a hyporeflective zone on the 7th postoperative day on OCT scan (time frame: 7 days postoperatively). 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 31 Oct 2017.