Diabetic Macular EdemaNCT03328715
iOCT for Patients With Diabetic Macular Edema
A study testing intraoperative OCT and stand-alone OCT in people with Diabetic Macular Edema, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
Patients will be examined before and after surgery with a stand-alone OCT and intraoperative microscope integrated OCT Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- intraoperative OCT and stand-alone OCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2016to 15 Jan 2024
- 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
- Cataract with the indication for surgery (visual symptoms) for both groups (study and control group)
- Diabetic macula edema - for the study group
- Age 21 and older
- written informed consent prior to surgery
Who cannot join
- Any relevant corneal disease
- In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Vienna, 1140
About this study
Official title: iOCT in Patients With Diabetic Macular Edema Scheduled for Phakoemulsification - a Pilot Study
Patients will be examined before and after surgery with a stand-alone OCT and intraoperative microscope integrated OCT
Read the detailed description
48 patients with and 48 patients without diabetic macular edema will be recruited for the study. Macular thickness measured with a stand-alone OCT and an intraoperative OCT will be assessed before and after phakoemulsification with intraocular lens Implantation.
- Conditions
- Diabetic Macular Edema
- Being tested
- intraoperative OCT, stand-alone OCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative OCTDevice
before and after surgery intraoperative OCT is performed
stand-alone OCTDevice
before and after surgery stand-alone OCT is performed
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | only patients with diabetic macular edema will be recruited in that arm, stand-alone OCT and intraoperative OCT will be performed before and after surgery Receives: Device: intraoperative OCT; Device: stand-alone OCT |
| controll group | Sham comparator | only patients without diabetic macular edema will be recruited in that arm, stand-alone OCT and intraoperative OCT will be performed before and after surgery Receives: Device: intraoperative OCT; Device: stand-alone OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
macular thickness
macular thickness is measured with the central subfield thickness function
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start1 Dec 2016
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 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, MD, Prof, Principal investigator, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328715
- Sponsor's protocol ID
- DMÖ-iOCT
- Status last verified
- Jun 2024
- First submitted
- 29 Oct 2017
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iOCT in Patients With Diabetic Macular Edema Scheduled for Phakoemulsification - a Pilot Study
- ClinicalTrials.gov ID
- NCT03328715
- Acronym / sponsor ID
- DMÖ-iOCT
- Conditions
- Diabetic Macular Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 1 Nov 2017 (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 will be examined before and after surgery with a stand-alone OCT and intraoperative microscope integrated OCT
Detailed description
48 patients with and 48 patients without diabetic macular edema will be recruited for the study. Macular thickness measured with a stand-alone OCT and an intraoperative OCT will be assessed before and after phakoemulsification with intraocular lens Implantation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Device: intraoperative OCT, Device: stand-alone OCTonly patients with diabetic macular edema will be recruited in that arm, stand-alone OCT and intraoperative OCT will be performed before and after surgery |
| controll group | Sham comparator | Device: intraoperative OCT, Device: stand-alone OCTonly patients without diabetic macular edema will be recruited in that arm, stand-alone OCT and intraoperative OCT will be performed before and after surgery |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cataract with the indication for surgery (visual symptoms) for both groups (study and control group)
- Diabetic macula edema - for the study group
- Age 21 and older
- written informed consent prior to surgery
Key exclusion criteria (2 listed)
- Any relevant corneal disease
- 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 |
|---|---|---|
| intraoperative OCTbefore and after surgery intraoperative OCT is performed | Device | controll group, study group |
| stand-alone OCTbefore and after surgery stand-alone OCT is performed | Device | controll group, study group |
Primary outcome
macular thickness
Time frame: 2 hours
macular thickness is measured with the central subfield thickness function
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 4 Jun 2024.
- Individual participant dataSharing planned: No
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A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)
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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 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 intraoperative OCT and stand-alone OCT in people with Diabetic Macular Edema, 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 4 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 4 Jun 2024. 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. Some participants in this study may receive a placebo. 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?
macular thickness (time frame: 2 hours). 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 4 Jun 2024.