Epiretinal Membrane SurgeryNCT02084212
Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery
A study testing Microperimetry in people with Epiretinal Membrane Surgery, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The aim of this research is to assess current care by studying macular function using microperimetry and by then comparing visual acuity results with OCT (Optical Coherence Tomography) data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epiretinal Membrane Surgery
- What is being tested?
- Microperimetry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2013to 24 Apr 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons who have provided consent,
- Patients about to undergo idiopathic epiretinal membrane surgery,
- Patients undergoing first-line macular surgery
Who cannot join
- Persons not covered by national health insurance
- Preexisting disease of macula/epiretinal membrane (ARMD, chorioretinal scarring)
- Preoperative amblyopic eye
- Insufficiently transparent media making it impossible to do the examinations
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this research is to assess current care by studying macular function using microperimetry and by then comparing visual acuity results with OCT (Optical Coherence Tomography) data.
The examinations performed are those usually done in the follow-up of epiretinal membrane surgery, apart from microperimetry which is an examination of the central visual field. Patients who undergo ERM surgery usually have a follow-up examination at 1 month, 3 months and 6 months after the surgery. The consultation includes an assessment of visual acuity, a fundus examination an SD-OCT of the retina. The present protocol will require no additional visits. The microperimetry will be done in addition to the usual follow-up examinations after ERM surgery.
- Conditions
- Epiretinal Membrane Surgery
- Being tested
- Microperimetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroperimetryOther
| Study group | Role | What they receive |
|---|---|---|
| Patients about to undergo epiretinal membrane surgery | Other | Not described Receives: Other: Microperimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of visual acuity in ETDRS (Early Treatment Diabetic Retinopathy Study) scale
Measured: Up to 6 months after the operation.
Anomalies observed in the outer layers of retina
Measured: Up to 6 months after the operation
Evaluation of retinal sensitivity by microperimetry
Measured: Up to 6 months after the operation
Secondary outcomes (1)
Abnormal surface autofluorescence
Measured: Up to 6 months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study start6 Mar 2013
- Primary completion24 Apr 2015
- Study completion24 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epiretinal Membrane SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Enrolment
- 6 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
- NCT02084212
- Sponsor's protocol ID
- ISAICO-MUSELIER AOI 2011
- Status last verified
- Sep 2019
- First submitted
- 5 Mar 2014
- Last updated
- 4 Sep 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Retinal Sensitivity by Microperimetry During Epiretinal Membrane Surgery
- ClinicalTrials.gov ID
- NCT02084212
- Acronym / sponsor ID
- ISAICO-MUSELIER AOI 2011
- Conditions
- Epiretinal Membrane Surgery
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 6 Mar 2013 (actual)
- Primary completion
- 24 Apr 2015 (actual)
- Study completion
- 24 Apr 2015 (actual)
- First posted
- 11 Mar 2014 (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.
The aim of this research is to assess current care by studying macular function using microperimetry and by then comparing visual acuity results with OCT (Optical Coherence Tomography) data.
The examinations performed are those usually done in the follow-up of epiretinal membrane surgery, apart from microperimetry which is an examination of the central visual field. Patients who undergo ERM surgery usually have a follow-up examination at 1 month, 3 months and 6 months after the surgery. The consultation includes an assessment of visual acuity, a fundus examination an SD-OCT of the retina. The present protocol will require no additional visits. The microperimetry will be done in addition to the usual follow-up examinations after ERM surgery.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients about to undergo epiretinal membrane surgery | Other | Other: Microperimetry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Persons who have provided consent,
- Patients about to undergo idiopathic epiretinal membrane surgery,
- Patients undergoing first-line macular surgery
Key exclusion criteria (4 listed)
- Persons not covered by national health insurance
- Preexisting disease of macula/epiretinal membrane (ARMD, chorioretinal scarring)
- Preoperative amblyopic eye
- Insufficiently transparent media making it impossible to do the examinations
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 |
|---|---|---|
| Microperimetry | Other | Patients about to undergo epiretinal membrane surgery |
Primary outcome
Change of visual acuity in ETDRS (Early Treatment Diabetic Retinopathy Study) scale
Time frame: Up to 6 months after the operation.
Anomalies observed in the outer layers of retina
Time frame: Up to 6 months after the operation
Evaluation of retinal sensitivity by microperimetry
Time frame: Up to 6 months after the operation
1 secondary outcome
Abnormal surface autofluorescence
Time frame: Up to 6 months after the operation
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microperimetry in people with Epiretinal Membrane Surgery, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 4 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: stopped early, as of the sponsor's last update on 4 Sep 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 France. 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 was stopped early. Results are not available in the source record.
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?
Change of visual acuity in ETDRS (Early Treatment Diabetic Retinopathy Study) scale (time frame: Up to 6 months after the operation.). The study lists 3 primary outcomes in all. 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 Sep 2019.