Epiretinal MembranesNCT02406430
Prognostic Factors in Epiretinal Membrane Surgery
An observational study of Epiretinal Membranes, run by Centre Hospitalier Universitaire Dijon.
Trial summary
Retrospective interventional case series study reporting preoperative clinical and anatomical factors associated with visual recovery 1 year after combined cataract and idiopathic epiretinal membrane surgery. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Epiretinal Membranes
- What is being tested?
- a combined cataract and ERM surgery
- Type of treatment
- Surgery or procedure
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Oct 2013
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients operated on for combined cataract and idiopathic epiretinal membrane
Who may be able to join
- symptomatic idiopathic epiretinal membrane operated on between April 2009 and September 2012 at the university hospital of Dijon, France.
- All patients signed informed consent for the surgical procedure.
Who cannot join
- Patients were excluded if they presented any cause of secondary epiretinal membrane (including diabetic retinopathy, vein occlusion, ocular inflammation, retinal detachment, or previously vitrectomized eye), high myopia (axial length ≥ 26 mm or spherical equivalent ≥ 6 diopters), severe media opacities with weak SD-OCT signal strengths, or any macular or optic nerve disease. Patients with a follow-up of less than 12 months were excluded and only one eye was included in those with bilateral epiretinal membranes.
About this study
Official title: Preoperative Prognostic Factors and Predictive Score in Patients Operated on for Combined Cataract and Idiopathic Epiretinal Membrane.
Retrospective interventional case series study reporting preoperative clinical and anatomical factors associated with visual recovery 1 year after combined cataract and idiopathic epiretinal membrane surgery. Age, duration of symptoms, and preoperative best corrected visual acuity appeared to be reliable prognostic factors. Combining these factors with analysis of the photoreceptors' inner and outer segments junction in spectral-domain optical coherence tomography provides a predictive score to estimate individual chances of good visual recovery
- Conditions
- Epiretinal Membranes
- Being tested
- a combined cataract and ERM surgery
- Medical subject headings
- Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a combined cataract and ERM surgeryProcedure or surgery
All patients underwent a combined cataract and ERM surgery owing to visual impairment or disabling metamorphopsia. A complete ophthalmological examination was performed before and at 1,6, and 12 months after the surgery, including best corrected visual acuity with Snellen charts converted into the logarithm of the minimum angle of resolution, slit-lamp biomicroscopy, indirect fundus, and macular optical coherence tomography
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
Best corrected visual acuity 1 year after the surgery, and preoperative factors associated with this visual outcome (age, duration of symptoms, initial best corrected visual acuity, and optical coherence tomography findings)
Measured: 1 year after the surgery
Secondary outcomes (1)
To set up a predictive score for a >= 20/20 best corrected visual acuity
To set up a predictive score for a >= 20/20 best corrected visual acuity, 1year after a combined cataract and epiretinal membrane surgery
Measured: 1 year after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startApr 2009
- Primary completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epiretinal MembranesStudies 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
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406430
- Sponsor's protocol ID
- CREUZOT 2013
- Status last verified
- Mar 2015
- First submitted
- 30 Mar 2015
- Last updated
- 2 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Prognostic Factors and Predictive Score in Patients Operated on for Combined Cataract and Idiopathic Epiretinal Membrane.
- ClinicalTrials.gov ID
- NCT02406430
- Acronym / sponsor ID
- CREUZOT 2013
- Conditions
- Epiretinal Membranes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Oct 2013 (actual)
- First posted
- 2 Apr 2015 (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.
Retrospective interventional case series study reporting preoperative clinical and anatomical factors associated with visual recovery 1 year after combined cataract and idiopathic epiretinal membrane surgery. Age, duration of symptoms, and preoperative best corrected visual acuity appeared to be reliable prognostic factors. Combining these factors with analysis of the photoreceptors' inner and outer segments junction in spectral-domain optical coherence tomography provides a predictive score to estimate individual chances of good visual recovery
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated on for combined cataract and idiopathic epiretinal membrane
Key inclusion criteria (2 listed)
- symptomatic idiopathic epiretinal membrane operated on between April 2009 and September 2012 at the university hospital of Dijon, France.
- All patients signed informed consent for the surgical procedure.
Key exclusion criteria (1 listed)
- Patients were excluded if they presented any cause of secondary epiretinal membrane (including diabetic retinopathy, vein occlusion, ocular inflammation, retinal detachment, or previously vitrectomized eye), high myopia (axial length ≥ 26 mm or spherical equivalent ≥ 6 diopters), severe media opacities with weak SD-OCT signal strengths, or any macular or optic nerve disease. Patients with a follow-up of less than 12 months were excluded and only one eye was included in those with bilateral epiretinal membranes.
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 |
|---|---|---|
| a combined cataract and ERM surgeryAll patients underwent a combined cataract and ERM surgery owing to visual impairment or disabling metamorphopsia. A complete ophthalmological examination was performed before and at 1,6, and 12 months after the surgery, including best corrected visual acuity with Snellen charts converted into the logarithm of the minimum angle of resolution, slit-lamp biomicroscopy, indirect fundus, and macular optical coherence tomography | Procedure or surgery | – |
Primary outcome
Best corrected visual acuity
Time frame: 1 year after the surgery
Best corrected visual acuity 1 year after the surgery, and preoperative factors associated with this visual outcome (age, duration of symptoms, initial best corrected visual acuity, and optical coherence tomography findings)
1 secondary outcome
To set up a predictive score for a >= 20/20 best corrected visual acuity
Time frame: 1 year after the surgery
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 2 Apr 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Epiretinal Membranes, run by Centre Hospitalier Universitaire Dijon.
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 2 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 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Best corrected visual acuity (time frame: 1 year after the surgery). 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 2 Apr 2015.