Macular DiseasesNCT02683694
Characteristics and Limitations of Intraoperative OCT Supported Membrane Peeling in Macular Diseases
A study testing iOCT in people with Macular Diseases, run by Vienna Institute for Research in Ocular Surgery 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
- Macular Diseases
- What is being tested?
- iOCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2015to Aug 2017
- 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, lamellar hole of the macula, macular hole and vitreomacular traction syndrome
Who cannot join
- Other diseases of the eye, such as AMD, retinopathia pigmentosa
Trial locations and contacts
1 site in 1 country.
About this 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), lamellar macular hole, macular hole and vitreomacular traction syndrome are disorders involving the posterior pole of the eyeball with consecutive vision loss. In patients with loss of vision and metamorphopsia disturbing their lifestyle, vitrectomy and membrane peeling is usually performed to remove traction and the ERM.
Different study groups showed that intraoperative use of SD-OCT is possible and improves the quality of peeling surgery.
Read the detailed description
The aim of the study is to assess the benefits and limits of intraoperative OCT (i-OCT), for example whether I-OCT assisted membrane peeling is possible without use of dyes for enabling better localistion of the ERM during surgery and to compare that scheme with different "gold standard" dyes for peeling such as membrane blue dual and triamcinolone. Rationale for that study is to work out which setting enables best visualisation of ERM and ILM (ILM) in i-OCT. A limitation of that method seems to be visualisation of the inner limiting membrane, so that dying of the ILM will probably be still necessary in all cases where ILM-peeling is sheduled.
- Conditions
- Macular Diseases
- Being tested
- iOCT
- Keywords
- Epiretinal membrane, lamellar holes of the macula, macular holes, vitreomacular traction syndrome
- Medical subject headings
- Epiretinal Membrane, Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iOCTDevice
Also called intraoperative OCT (iOCT)
the number of subjects that can be peeled without dye are assessed
| Study group | Role | What they receive |
|---|---|---|
| study arm | Other | iOCT is performed Receives: Device: iOCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
peeling without staining
number of patients that could be peeled without use of a dye
Measured: intraoperative (10-15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startFeb 2015
- Primary completionMay 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DiseasesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 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, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683694
- Sponsor's protocol ID
- iOC
- Status last verified
- Mar 2018
- First submitted
- 12 Feb 2016
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Limitations of Intraoperative OCT Supported Membrane Peeling in Macular Diseases
- ClinicalTrials.gov ID
- NCT02683694
- Acronym / sponsor ID
- iOC
- Conditions
- Macular Diseases
- Keywords
- Epiretinal membrane, lamellar holes of the macula, macular holes, vitreomacular traction syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- May 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 17 Feb 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.
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), lamellar macular hole, macular hole and vitreomacular traction syndrome are disorders involving the posterior pole of the eyeball with consecutive vision loss. In patients with loss of vision and metamorphopsia disturbing their lifestyle, vitrectomy and membrane peeling is usually performed to remove traction and the ERM.
Different study groups showed that intraoperative use of SD-OCT is possible and improves the quality of peeling surgery.
Detailed description
The aim of the study is to assess the benefits and limits of intraoperative OCT (i-OCT), for example whether I-OCT assisted membrane peeling is possible without use of dyes for enabling better localistion of the ERM during surgery and to compare that scheme with different "gold standard" dyes for peeling such as membrane blue dual and triamcinolone. Rationale for that study is to work out which setting enables best visualisation of ERM and ILM (ILM) in i-OCT. A limitation of that method seems to be visualisation of the inner limiting membrane, so that dying of the ILM will probably be still necessary in all cases where ILM-peeling is sheduled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study arm | Other | Device: iOCTiOCT is performed |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Epiretinal Membrane, lamellar hole of the macula, macular hole and vitreomacular traction syndrome
Key exclusion criteria (1 listed)
- Other diseases of the eye, such as AMD, retinopathia pigmentosa
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 |
|---|---|---|
| iOCTAlso: intraoperative OCT (iOCT)the number of subjects that can be peeled without dye are assessed | Device | study arm |
Primary outcome
peeling without staining
Time frame: intraoperative (10-15 minutes)
number of patients that could be peeled without use of a dye
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 9 Mar 2018.
- 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, Prof principal investigator
Vienna Institute for Research in Ocular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iOCT in people with Macular Diseases, 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 1 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 9 Mar 2018. 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?
peeling without staining (time frame: intraoperative (10-15 minutes)). 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 9 Mar 2018.