Epimacular GliosisNCT01083056
Observational Study - ILM Peeling
An observational study of Epimacular Gliosis and Macular Hole, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
This observational study investigates the effects of epimacular membrane peeling on the structure and function of the retina. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epimacular Gliosis, Macular Hole
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Jul 2014
- 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: Inpatients at the University Eye Hospital Tuebingen
Who may be able to join
- Clinical diagnosis of Epimacular Gliosis
- Must be scheduled for ILM-peeling independently of study
- Must be older then 18 years of age
Who cannot join
- Visual acuity > 0,4 logMAR (< 20/50 EDTRS)
- Other ophthalmological disorder affecting visual acuity and/or visual field and/or retinal structure
Trial locations and contacts
1 site in 1 country.
Germany1 site
Centre for Ophthalmology, University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Observational Study On Retinal Structure And Function Before And After Epimacular Membrane Peeling
This observational study investigates the effects of epimacular membrane peeling on the structure and function of the retina.
- Conditions
- Epimacular Gliosis, Macular Hole
- Keywords
- retina, gliosis, macula, membrane, ILM
- Medical subject headings
- Retinal Perforations, Gliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Epimacular Gliosis Without Macular Hole | Not described | |
| Epimacular Gliosis With Macular Hole | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
Measured: 6 months after ILM peeling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epimacular GliosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Dominik Fischer, University Hospital Tuebingen
- Investigators
- Florian Gekeler, MD, Principal investigator, Centre for Ophthalmology, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083056
- Sponsor's protocol ID
- ILM Peeling
- Status last verified
- Jul 2014
- First submitted
- 8 Mar 2010
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study On Retinal Structure And Function Before And After Epimacular Membrane Peeling
- ClinicalTrials.gov ID
- NCT01083056
- Acronym / sponsor ID
- ILM Peeling
- Conditions
- Epimacular Gliosis, Macular Hole
- Keywords
- retina, gliosis, macula, membrane, ILM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 Mar 2010 (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.
This observational study investigates the effects of epimacular membrane peeling on the structure and function of the retina.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epimacular Gliosis Without Macular Hole | – | – |
| Epimacular Gliosis With Macular Hole | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients at the University Eye Hospital Tuebingen
Key inclusion criteria (3 listed)
- Clinical diagnosis of Epimacular Gliosis
- Must be scheduled for ILM-peeling independently of study
- Must be older then 18 years of age
Key exclusion criteria (2 listed)
- Visual acuity > 0,4 logMAR (< 20/50 EDTRS)
- Other ophthalmological disorder affecting visual acuity and/or visual field and/or retinal structure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BCVA
Time frame: 6 months after ILM peeling
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 Jul 2014.
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.
Florian Gekeler, MD principal investigator
Centre for Ophthalmology, University Hospital Tuebingen
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 Epimacular Gliosis and Macular Hole, run by University Hospital Tuebingen 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 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 Jul 2014. 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?
BCVA (time frame: 6 months after ILM peeling). 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 Jul 2014.