Epiretinal MembraneERMP&ILMNCT04802265
EpiRetinal Membrane Peeling and Internal Limiting Membrane
An observational study of Epiretinal Membrane and Macular Pucker, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
To study and compare visual acuity in patients undergoing removal of the epiretinal membrane with and without the removal of the internal limiting membrane at baseline versus 6 month. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Epiretinal Membrane, Macular Pucker, Internal Limiting Membrane
- What is being tested?
- Epiretinal membrane surgery
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 21 May 2021to 1 Aug 2021
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult diagnosed for epiretinal surgery
Who may be able to join
- adult up to 18 years old,
- diagnosed and treated surgically
Who cannot join
- proliferative diabetic retinopathy,
- ocular trauma,
- central veinous occlusion,
- intra-ocular tumor, total retinal detachment,
- central visual field loss in glaucomatous patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Compare Anatomical and Functionnal Outcomes in Patients Undergoing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Peeling
To study and compare visual acuity in patients undergoing removal of the epiretinal membrane with and without the removal of the internal limiting membrane at baseline versus 6 month.
Read the detailed description
This prospective cohort study includes 2 arms : with and without internal limiting membrane (ILM) peeling.
Each patient undergo the same procedure : first of all pars plana vitrectomy, then internal limiting membrane peeling is performed and facilitated by the use of dye, which aids in better visualization of the ILM.
If the ILM is removed in same time : the patient is ranked in the "ILM peeling" group If the ILM is not removed : the patient is ranked in the "non ILM peeling" group.
If the ILM is partially removed, the patient is not enrolled.
The outcomes are recorded for 6 months : at baseline, day 15, 1, 3 and 6 months.
- Being tested
- Epiretinal membrane surgery
- Keywords
- Epiretinal membrane, Epiretinal membrane peeling, Macular pucker, Internal limiting membrane (ILM) peeling, Pars plana vitrectomy
- Medical subject headings
- Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epiretinal membrane surgeryProcedure or surgery
The surgery consists of a 23 or 25-gauge pars plana vitrectomy (PPV). The surgery was performed peri-bulbar anesthesia and could be combined with phacoemulsification.
An intraocular dye is used to well visualized and facilitate ERM peeling. The ILM is not actively peeled. A search for iatrogenic breaks is performed towards the end of the procedure. Areas suspicious for breaks are treated with cryotherapy or peripheral endolaser.
| Study group | Role | What they receive |
|---|---|---|
| ILM peeling | ILM is peeled during epiretinal membrane surgery Receives: Procedure: Epiretinal membrane surgery | |
| without ILM peeling | ILM is not peeled during epiretinal membrane surgery Receives: Procedure: Epiretinal membrane surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity (BCVA) (metric : LogMAR)
BCVA is measured at each medical appointment. Monoyer Scale is used and results are converted in LogMAR scale.
Measured: prior to surgery
Best corrected visual acuity (BCVA) (metric : LogMAR)
BCVA is measured at each medical appointment. Monoyer Scale is used and results are converted in LogMAR scale.
Measured: Day 180
Secondary outcomes (5)
BCVA at day 15, 1, 3 month.
BCVA is measured at each medical appointment. Monoyer Scale is used and. Resulats are converted in LogMAR scale.
Measured: Day 15, Day 30, Day 90
near visual acuity measured at baseline, day 15, 1, 3 and 6 month
near visual acuity is measured at each medical appointment using Parinaud Scale
Measured: Day 180
central retinal thickness (CRT)
CRT is measured on optical coherence tomography (OCT) at baseline, day 15, 1 , 3 and 6 months
Measured: Day 180
peeling initiation retinal thickness
to evaluate the damage due to the membrane gripping during the peeling initiation, retinal thickness is performed at this location by OCT.
Measured: Day 180
10° visual field
a 10° Visual Field is performed at baseline, 1 month and 6 month
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start21 May 2021
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Why it stopped: departure of the intern in charge of the study
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Sillaire, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802265
- Sponsor's protocol ID
- RBHP 2021 SILLAIRE
- Other IDs
- 2021-A00071-40
- Acronym
- ERMP&ILM
- Status last verified
- Oct 2023
- First submitted
- 10 Mar 2021
- Last updated
- 23 Oct 2023
- 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 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare Anatomical and Functionnal Outcomes in Patients Undergoing Epiretinal Membrane Surgery With and Without Internal Limiting Membrane Peeling
- ClinicalTrials.gov ID
- NCT04802265
- Acronym / sponsor ID
- ERMP&ILM / RBHP 2021 SILLAIRE
- Keywords
- Epiretinal membrane, Epiretinal membrane peeling, Macular pucker, Internal limiting membrane (ILM) peeling, Pars plana vitrectomy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: departure of the intern in charge of the study
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 17 Mar 2021 (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.
To study and compare visual acuity in patients undergoing removal of the epiretinal membrane with and without the removal of the internal limiting membrane at baseline versus 6 month.
Detailed description
This prospective cohort study includes 2 arms : with and without internal limiting membrane (ILM) peeling.
Each patient undergo the same procedure : first of all pars plana vitrectomy, then internal limiting membrane peeling is performed and facilitated by the use of dye, which aids in better visualization of the ILM.
If the ILM is removed in same time : the patient is ranked in the "ILM peeling" group If the ILM is not removed : the patient is ranked in the "non ILM peeling" group.
If the ILM is partially removed, the patient is not enrolled.
The outcomes are recorded for 6 months : at baseline, day 15, 1, 3 and 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ILM peeling | – | Procedure: Epiretinal membrane surgeryILM is peeled during epiretinal membrane surgery |
| without ILM peeling | – | Procedure: Epiretinal membrane surgeryILM is not peeled during epiretinal membrane surgery |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult diagnosed for epiretinal surgery
Key inclusion criteria (2 listed)
- adult up to 18 years old,
- diagnosed and treated surgically
Key exclusion criteria (5 listed)
- proliferative diabetic retinopathy,
- ocular trauma,
- central veinous occlusion,
- intra-ocular tumor, total retinal detachment,
- central visual field loss in glaucomatous patients
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 |
|---|---|---|
| Epiretinal membrane surgeryThe surgery consists of a 23 or 25-gauge pars plana vitrectomy (PPV). The surgery was performed peri-bulbar anesthesia and could be combined with phacoemulsification. An intraocular dye is used to well visualized and facilitate ERM peeling. The ILM is not actively peeled. A search for iatrogenic breaks is performed towards the end of the procedure. Areas suspicious for breaks are treated with cryotherapy or peripheral endolaser. | Procedure or surgery | ILM peeling, without ILM peeling |
Primary outcome
Best corrected visual acuity (BCVA) (metric : LogMAR)
Time frame: prior to surgery
BCVA is measured at each medical appointment. Monoyer Scale is used and results are converted in LogMAR scale.
Best corrected visual acuity (BCVA) (metric : LogMAR)
Time frame: Day 180
BCVA is measured at each medical appointment. Monoyer Scale is used and results are converted in LogMAR scale.
5 secondary outcomes
BCVA at day 15, 1, 3 month.
Time frame: Day 15, Day 30, Day 90
near visual acuity measured at baseline, day 15, 1, 3 and 6 month
Time frame: Day 180
central retinal thickness (CRT)
Time frame: Day 180
peeling initiation retinal thickness
Time frame: Day 180
10° visual field
Time frame: Day 180
Results and safety
The study was stopped early (reason given: departure of the intern in charge of the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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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.
Isabelle Sillaire principal investigator
University Hospital, Clermont-Ferrand
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 Pucker, run by University Hospital, Clermont-Ferrand 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 2 inclusion and 5 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 23 Oct 2023. 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 (reason given: departure of the intern in charge of the study). 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?
Best corrected visual acuity (BCVA) (metric : LogMAR) (time frame: prior to surgery). The study lists 2 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 23 Oct 2023.