Epiretinal MembraneNCT03927430
Surgical Outcome of Macular Membrane Peeling Associated With Significant Macular Drusen
An observational study of Epiretinal Membrane and Macular Holes, run by Klinikum Chemnitz gGmbH at 1 site in Germany.
Trial summary
Surgical outcome of patients with macular drusen and co-existing abnormalities of the vitreoretinal interface, who routinely undergo pars plana vitrectomy with membrane peeling, is evaluated. Best corrected visual acuity as well as optical coherence tomography data are compared at baseline and last follow up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epiretinal Membrane, Macular Holes, Age Related Macular Degeneration
- What is being tested?
- pars plana vitrectomy with membrane peeling
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2019to 1 Mar 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: mostly elderly people, mean age 66 years, both males and females
Who may be able to join
- participants diagnosed with ERM or FTMH and co-existing macular drusen;
- undergone pars plana vitrectomy with ILM and epiretinale membrane peeling;
- SD-OCT at the initial visit and at last follow up visit with image quality score >30;
- no evidence of CNV on initial fluorescein angiography (FA).
Who cannot join
- history of other macular disease, severe non-proliferative or proliferative diabetic retinopathy, other retinal vascular diseases, glaucoma, myopic retinopathy, or other diseases interfering with OCT images in any one of the eyes;
- active CNV or history of CNV
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum Chemnitz, Ophthalmology Department
Chemnitz, Saxony, 09116
About this study
Official title: To Peel or Not to Peel: Surgical Outcome of Macular Membrane Peeling Associated With Significant Macular Drusen
Surgical outcome of patients with macular drusen and co-existing abnormalities of the vitreoretinal interface, who routinely undergo pars plana vitrectomy with membrane peeling, is evaluated. Best corrected visual acuity as well as optical coherence tomography data are compared at baseline and last follow up. The rate of development of choroidal neovascularization postoperatively is noted.
- Being tested
- pars plana vitrectomy with membrane peeling
- Medical subject headings
- Epiretinal Membrane, Retinal Perforations, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pars plana vitrectomy with membrane peelingProcedure or surgery
23-gauge pars plana vitrectomy with peeling of the epiretinal and internal limiting membrane as well as air- or gastamponade
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with CNV
number of patients with CNV (choroidal neovascularization) development
Measured: last visit, in common 6 months postoperatively
Secondary outcomes (2)
BCVA
best corrected visual acuity
Measured: last visit, in common 6 months postoperatively
incidence of central retinal atrophy
development of central retinal atrophy on OCT
Measured: last visit, in common 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start1 Jan 2019
- Primary completion1 Mar 2019
- Study completion1 Mar 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Chemnitz gGmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrin Engelmann, Klinikum Chemnitz gGmbH
- Investigators
- Katrin Engelmann, PhD, Study chair, Klinikum Chemnitz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927430
- Sponsor's protocol ID
- SKC01/2019
- Status last verified
- Apr 2019
- First submitted
- 15 Apr 2019
- Last updated
- 1 May 2019
- 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 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Peel or Not to Peel: Surgical Outcome of Macular Membrane Peeling Associated With Significant Macular Drusen
- ClinicalTrials.gov ID
- NCT03927430
- Acronym / sponsor ID
- SKC01/2019
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Klinikum Chemnitz gGmbHUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 25 Apr 2019 (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.
Surgical outcome of patients with macular drusen and co-existing abnormalities of the vitreoretinal interface, who routinely undergo pars plana vitrectomy with membrane peeling, is evaluated. Best corrected visual acuity as well as optical coherence tomography data are compared at baseline and last follow up. The rate of development of choroidal neovascularization postoperatively is noted.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- mostly elderly people, mean age 66 years, both males and females
Key inclusion criteria (4 listed)
- participants diagnosed with ERM or FTMH and co-existing macular drusen;
- undergone pars plana vitrectomy with ILM and epiretinale membrane peeling;
- SD-OCT at the initial visit and at last follow up visit with image quality score >30;
- no evidence of CNV on initial fluorescein angiography (FA).
Key exclusion criteria (2 listed)
- history of other macular disease, severe non-proliferative or proliferative diabetic retinopathy, other retinal vascular diseases, glaucoma, myopic retinopathy, or other diseases interfering with OCT images in any one of the eyes;
- active CNV or history of CNV
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 |
|---|---|---|
| pars plana vitrectomy with membrane peeling23-gauge pars plana vitrectomy with peeling of the epiretinal and internal limiting membrane as well as air- or gastamponade | Procedure or surgery | – |
Primary outcome
number of patients with CNV
Time frame: last visit, in common 6 months postoperatively
number of patients with CNV (choroidal neovascularization) development
2 secondary outcomes
BCVA
Time frame: last visit, in common 6 months postoperatively
incidence of central retinal atrophy
Time frame: last visit, in common 6 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 1 May 2019.
- Individual participant dataSharing planned: No
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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.
Katrin Engelmann, PhD study chair
Klinikum Chemnitz
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 Epiretinal Membrane and Macular Holes, run by Klinikum Chemnitz gGmbH at 1 site in Germany.
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 1 May 2019. 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 Germany. 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?
number of patients with CNV (time frame: last visit, in common 6 months 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 1 May 2019.