Epiretinal MembraneNCT04281173
Evaluation of Multifocal ERG and Visual Field Changes After Vitrectomy and ILM Peeling
An observational study of Epiretinal Membrane, run by Assiut University.
Trial summary
To evulate changes in MfERG, VF and OCT after viterctomy associated with ILM peeling. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epiretinal Membrane
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with diopathic ERM,Primary full thickness macular hole, Lamellar macular hole, and Vitromacular traction
Who may be able to join
- Idiopathic ERM,
- Primary full thickness macular hole,
- Lamellar macular hole, and
- Vitromacular traction
Who cannot join
- 1-Patients with a secondary ERM,
- diabetic retinopathy,
- venous occlusion,
- retinal detachment,
- uveitis, and
- trauma. 2-Other ocular pathologies that could interfere with the functional results
Show all 10Show fewer
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- dense cataract ,
- glaucoma, and
- previous retinal surgery
About this study
To evulate changes in MfERG, VF and OCT after viterctomy associated with ILM peeling.
Read the detailed description
Macular epiretinal membrane (ERM) is a disorder of the vitreomacular interface characterized by fibrocellular proliferation on the anterior surface of the internal limiting membrane (ILM) of the macula. Pars plana vitrectomy with ERM removal and inner limiting membrane peeling is the standard surgical treatment for an ERM. ILM peeling is performed to eliminate the scaffold for myofibroblast proliferation and any microscopic ERM in order to prevent ERM recurrence. ILM peeling is indicated for other pathologies other than ERM such as, diabetic macular edema, and macular hole. ILM peeling is a traumatic procedure that may have many effects on the underlying inner retinal layers that may lead to changes in retinal function.
Retinal edema, eccentric scotoma, dissociation of the nerve fiber layer, iatrogenic punctuate chorioretinopathy, and subretinal, retinal, and vitreous hemorrhage are well described secondary to the surgical trauma of peeling in addition to stain toxicity. Investigation of these changes may assist in aiding the development of minimally traumatic techniques for ILM removal .
Evaluation of functional changes may include visual field and Multifocal electroretinography assessment. Visual field defect after vitrectomy a well known post operative complication usually in eyes that underwent fluid air exchange, the cause of visual field defect remain unclear.
Optical Coherence Tomography (OCT), imaging is done to evaluate inner retinal layers after ILM peeling,High myopic eyes might develop more severe, "scattered" inner retinal defects after ILM peeling.
Multifocal electroretinography (mfERG), has been used to assess visual function and the electrophysiologic responses of multiple retinal locations of the macular area
- Conditions
- Epiretinal Membrane
- Medical subject headings
- Epiretinal Membrane
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
after ILM peeling
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epiretinal MembraneStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Almoatz bellah zohier Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281173
- Sponsor's protocol ID
- ERG in ILM peeling
- Status last verified
- Feb 2020
- First submitted
- 20 Feb 2020
- Last updated
- 25 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mensch G. Dental licensing. Midwest Dent. 1968 Oct;44(10):13. No abstract available.
PubMed 5247634
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Multifocal ERG and Visual Field Changes After Vitrectomy and ILM Peeling
- ClinicalTrials.gov ID
- NCT04281173
- Acronym / sponsor ID
- ERG in ILM peeling
- Conditions
- Epiretinal Membrane
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 24 Feb 2020 (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 evulate changes in MfERG, VF and OCT after viterctomy associated with ILM peeling.
Detailed description
Macular epiretinal membrane (ERM) is a disorder of the vitreomacular interface characterized by fibrocellular proliferation on the anterior surface of the internal limiting membrane (ILM) of the macula. Pars plana vitrectomy with ERM removal and inner limiting membrane peeling is the standard surgical treatment for an ERM. ILM peeling is performed to eliminate the scaffold for myofibroblast proliferation and any microscopic ERM in order to prevent ERM recurrence. ILM peeling is indicated for other pathologies other than ERM such as, diabetic macular edema, and macular hole. ILM peeling is a traumatic procedure that may have many effects on the underlying inner retinal layers that may lead to changes in retinal function.
Retinal edema, eccentric scotoma, dissociation of the nerve fiber layer, iatrogenic punctuate chorioretinopathy, and subretinal, retinal, and vitreous hemorrhage are well described secondary to the surgical trauma of peeling in addition to stain toxicity. Investigation of these changes may assist in aiding the development of minimally traumatic techniques for ILM removal .
Evaluation of functional changes may include visual field and Multifocal electroretinography assessment. Visual field defect after vitrectomy a well known post operative complication usually in eyes that underwent fluid air exchange, the cause of visual field defect remain unclear.
Optical Coherence Tomography (OCT), imaging is done to evaluate inner retinal layers after ILM peeling,High myopic eyes might develop more severe, "scattered" inner retinal defects after ILM peeling.
Multifocal electroretinography (mfERG), has been used to assess visual function and the electrophysiologic responses of multiple retinal locations of the macular area
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with diopathic ERM,Primary full thickness macular hole, Lamellar macular hole, and Vitromacular traction
Key inclusion criteria (4 listed)
- Idiopathic ERM,
- Primary full thickness macular hole,
- Lamellar macular hole, and
- Vitromacular traction
Key exclusion criteria (10 listed)
- 1-Patients with a secondary ERM,
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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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Background: PubMed 5247634Mensch G. Dental licensing. Midwest Dent. 1968 Oct;44(10):13. No abstract available.
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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 Membrane, run by Assiut University.
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 4 inclusion and 10 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 25 Feb 2020. 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?
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?
BCVA (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04281173, which also lists 1 linked publication.
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 25 Feb 2020.