Macular Edema, CystoidNCT04472039
Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling
An observational study of Macular Edema, Cystoid, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
Aim of the study is to assess the rate of postoperative intraretinal cystoid changes after pars plana vitrectomy with membrane peeling and peribulbar application of triamcinolone acetonide and to examine possible risk factors for postoperative intraretinal cystoid changes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema, Cystoid
- What is being tested?
- optical coherence tomography (OCT)
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 30 Jun 2020to 28 Sep 2020
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients having undergone pars plana vitrectomy with membrane peeling and periocular application of triamcinolone acetonide at the end of surgery between June 2019 and January 2020 at the department of Ophthalmology of the Hanusch Hospital in Vienna, Austria, were selected for the study
Who may be able to join
- presence of an ERM
- indication for membrane peeling defined as significant loss of vision and/or metamorphopsia due to the ERM
- application of periocular triamcinolone acetonide at the end of surgery
- at least one follow-up examination present in the patient's history
Who cannot join
- macular edema caused by conditions other than ERM (such as choroidal neovascularization, diabetic macular edema, etc.)
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
Aim of the study is to assess the rate of postoperative intraretinal cystoid changes after pars plana vitrectomy with membrane peeling and peribulbar application of triamcinolone acetonide and to examine possible risk factors for postoperative intraretinal cystoid changes.
Read the detailed description
Epiretinal membranes (ERM) are disorders leading to vision loss and metamorphopsia. Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of ERM. Nevertheless, there are about 10% of patients having intraretinal cystoid changes after surgery with potential for disturbance of visual acuity. The aim of the study is to assess the rate of postoperative intraretinal cystoid changes after pars plana vitrectomy with membrane peeling and peribulbar application of triamcinolone acetonide and to examine possible risk factors for postoperative intraretinal cystoid changes.
- Conditions
- Macular Edema, Cystoid
- Being tested
- optical coherence tomography (OCT)
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical coherence tomography (OCT)Device
OCT visualizes the retinal layers by backreflection of light
| Study group | Role | What they receive |
|---|---|---|
| Studygroup | Retrospective analysis of OCT, IOP and distance corrected visual acuity from the patients history. Receives: Device: optical coherence tomography (OCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraretinal cystoid changes
presence of intraretinal cystoid changes in OCT is assessed during the time period of 3 months after surgery
Measured: 3 months
Secondary outcomes (2)
intraocular pressure (IOP)
intraocular pressure is examined during the time period of 3 months after surgery
Measured: 3 months
distance corrected visual acuity
distance corrected visual acuity is measured at baseline and 3 months after surgery
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 posted15 Jul 2020
- Study start30 Jun 2020
- Primary completion28 Sep 2020
- Study completion28 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Edema, CystoidStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40 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
- NCT04472039
- Sponsor's protocol ID
- RAC
- Status last verified
- Sep 2020
- First submitted
- 11 Jul 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- 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
- Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling
- ClinicalTrials.gov ID
- NCT04472039
- Acronym / sponsor ID
- RAC
- Conditions
- Macular Edema, Cystoid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 28 Sep 2020 (actual)
- First posted
- 15 Jul 2020 (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.
Aim of the study is to assess the rate of postoperative intraretinal cystoid changes after pars plana vitrectomy with membrane peeling and peribulbar application of triamcinolone acetonide and to examine possible risk factors for postoperative intraretinal cystoid changes.
Detailed description
Epiretinal membranes (ERM) are disorders leading to vision loss and metamorphopsia. Vitrectomy with membrane peeling has developed to be the gold-standard in treatment of ERM. Nevertheless, there are about 10% of patients having intraretinal cystoid changes after surgery with potential for disturbance of visual acuity. The aim of the study is to assess the rate of postoperative intraretinal cystoid changes after pars plana vitrectomy with membrane peeling and peribulbar application of triamcinolone acetonide and to examine possible risk factors for postoperative intraretinal cystoid changes.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Studygroup | – | Device: optical coherence tomography (OCT)Retrospective analysis of OCT, IOP and distance corrected visual acuity from the patients history. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients having undergone pars plana vitrectomy with membrane peeling and periocular application of triamcinolone acetonide at the end of surgery between June 2019 and January 2020 at the department of Ophthalmology of the Hanusch Hospital in Vienna, Austria, were selected for the study
Key inclusion criteria (4 listed)
- presence of an ERM
- indication for membrane peeling defined as significant loss of vision and/or metamorphopsia due to the ERM
- application of periocular triamcinolone acetonide at the end of surgery
- at least one follow-up examination present in the patient's history
Key exclusion criteria (1 listed)
- macular edema caused by conditions other than ERM (such as choroidal neovascularization, diabetic macular edema, etc.)
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 |
|---|---|---|
| optical coherence tomography (OCT)OCT visualizes the retinal layers by backreflection of light | Device | Studygroup |
Primary outcome
Intraretinal cystoid changes
Time frame: 3 months
presence of intraretinal cystoid changes in OCT is assessed during the time period of 3 months after surgery
2 secondary outcomes
intraocular pressure (IOP)
Time frame: 3 months
distance corrected visual acuity
Time frame: 3 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 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
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?
An observational study of Macular Edema, Cystoid, 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 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 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?
Intraretinal cystoid changes (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; AzTrials last refreshed its copy on 27 Oct 2026.