Epiretinal MembraneNCT04802915
Intraoperative Analysis of the Central Retina in ERF
A study testing Intraoperative ERM and ILM staining with their assessment and removal in people with Epiretinal Membrane and Macular Pucker, run by The S.N. Fyodorov Eye Microsurgery State Institution at 1 site in Russia.
Trial summary
Changes in the retinal anatomy that occur in epiretinal fibrosis have not been sufficiently studied. It is possible that epiretinal fibrosis leads not only to traction dislocation of the macula, but also to ILM anatomical disorders. Read more about this study
- Who is it for?
- Ages 50 to 82 years
- Conditions the study is for
- Epiretinal Membrane, Macular Pucker
- What is being tested?
- Intraoperative ERM and ILM staining with their assessment and removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 15 Jan 2019to Dec 2022
- 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 50 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BCVA < 0,6;
Who cannot join
- secondary ERM, glaucoma, diabetic retinopathy, high myopia, BCVA>0,6
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
S.N. Fedorov Nmrc "Mntk "Eye Microsurgery"
Moscow, 127486
Pavel V Lyskin, PhD, +74994888926, plyskin@yahoo.com
Irina R Makarenko, MD, +79032101254, makarenkoirina505@gmail.com
About this study
Official title: Intraoperative Analysis of the Central Retina in Epiretinal Fibrosis
Changes in the retinal anatomy that occur in epiretinal fibrosis have not been sufficiently studied. It is possible that epiretinal fibrosis leads not only to traction dislocation of the macula, but also to ILM anatomical disorders.
Read the detailed description
Purpose: to study anatomical changes in the Central retina in epiretinal fibrosis.
Surgical treatment: standard vitrectomy 25-27G; ERM amd ILM stainig by Membrane Blue Dual; epiretinal membrane removal, ILM peeling if the divulsion of ILM was detected.
Expected results: improving the quality of epiretinal fibrosis surgery by obtaining a more detailed picture of the pathological process
- Conditions
- Epiretinal Membrane, Macular Pucker
- Being tested
- Intraoperative ERM and ILM staining with their assessment and removal
- Keywords
- epiretinal membrane, internal limiting membrane, epiretinal fibrosis, macular pucker, central retina
- Medical subject headings
- Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative ERM and ILM staining with their assessment and removalProcedure or surgery
ERM and ILM staining is performed after vitrectomy. After that we evaluate the condition of macular zone and make a decision to remove the ERM and the need to remove the ILM
| Study group | Role | What they receive |
|---|---|---|
| epiretinal membrane group | Other | Patient with epiretinal fibrosis confirmed by OCT with BCVA< 0,6 and complaints of metamorphopsies Receives: Procedure: Intraoperative ERM and ILM staining with their assessment and removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
ILM integrity
Visual intraoperative assessment of the ILM integrity
Measured: intraoperative
Length and localization of the ILM dialysis
Length (in degrees) and localization of the ILM dyalisis
Measured: intraoperative
ILM displacement
ILM displacement direction during the formation of detachment and divulsion.
Measured: intraoperative
Occurence of ILM dyalisis
Determination of the ratio of patients with ILM dialysis to the total number of patients with ERF
Measured: intraoperative
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 start15 Jan 2019
- Primary completionJan 2022 (estimated)
- Study completionDec 2022 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The S.N. Fyodorov Eye Microsurgery State Institution
- Sponsor type
- Other government
- Collaborators
- Makarenko Irina Romanovna, Zgoba Mariana Igorevna
- Responsible party
- Principal investigator, Lyskin Pavel Vladimirovich, MD, PhD, The S.N. Fyodorov Eye Microsurgery State Institution
- Investigators
- Pavel V Lyskin, PhD, Principal investigator, The S.N. Fyodorov Eye Microsurgery State Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802915
- Sponsor's protocol ID
- 124575
- Status last verified
- Mar 2021
- First submitted
- 6 Dec 2020
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- 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 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Analysis of the Central Retina in Epiretinal Fibrosis
- ClinicalTrials.gov ID
- NCT04802915
- Acronym / sponsor ID
- 124575
- Conditions
- Epiretinal Membrane, Macular Pucker
- Keywords
- epiretinal membrane, internal limiting membrane, epiretinal fibrosis, macular pucker, central retina
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The S.N. Fyodorov Eye Microsurgery State InstitutionOther government
- Collaborators
- Makarenko Irina Romanovna, Zgoba Mariana Igorevna
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- 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.
Changes in the retinal anatomy that occur in epiretinal fibrosis have not been sufficiently studied. It is possible that epiretinal fibrosis leads not only to traction dislocation of the macula, but also to ILM anatomical disorders.
Detailed description
Purpose: to study anatomical changes in the Central retina in epiretinal fibrosis.
Surgical treatment: standard vitrectomy 25-27G; ERM amd ILM stainig by Membrane Blue Dual; epiretinal membrane removal, ILM peeling if the divulsion of ILM was detected.
Expected results: improving the quality of epiretinal fibrosis surgery by obtaining a more detailed picture of the pathological process
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| epiretinal membrane group | Other | Procedure: Intraoperative ERM and ILM staining with their assessment and removalPatient with epiretinal fibrosis confirmed by OCT with BCVA< 0,6 and complaints of metamorphopsies |
Who may qualify
- Ages
- 50 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BCVA < 0,6;
Key exclusion criteria (1 listed)
- secondary ERM, glaucoma, diabetic retinopathy, high myopia, BCVA>0,6
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 |
|---|---|---|
| Intraoperative ERM and ILM staining with their assessment and removalERM and ILM staining is performed after vitrectomy. After that we evaluate the condition of macular zone and make a decision to remove the ERM and the need to remove the ILM | Procedure or surgery | epiretinal membrane group |
Primary outcome
ILM integrity
Time frame: intraoperative
Visual intraoperative assessment of the ILM integrity
Length and localization of the ILM dialysis
Time frame: intraoperative
Length (in degrees) and localization of the ILM dyalisis
ILM displacement
Time frame: intraoperative
ILM displacement direction during the formation of detachment and divulsion.
Occurence of ILM dyalisis
Time frame: intraoperative
Determination of the ratio of patients with ILM dialysis to the total number of patients with ERF
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- 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.
Pavel V Lyskin, PhD principal investigator
The S.N. Fyodorov Eye Microsurgery State Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative ERM and ILM staining with their assessment and removal in people with Epiretinal Membrane and Macular Pucker, run by The S.N. Fyodorov Eye Microsurgery State Institution at 1 site in Russia.
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 1 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: status not confirmed, as of the sponsor's last update on 17 Mar 2021. 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 Russia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pavel V Lyskin, PhD (+74994888926, plyskin@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ILM integrity (time frame: intraoperative). The study lists 4 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 17 Mar 2021.