ILM PeelingNCT04312620
Evaluation of OCT and Visual Field Changes After Vitrectomy and ILM Peeling
An observational study of ILM Peeling, run by Assiut University.
Trial summary
To evulate changes in VF and OCT after viterctomy associated with ILM peeling. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- ILM Peeling
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to 8 Apr 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients withIdiopathic ERM,Primary full thickness macular hole,Lamellar macular hole, andVitromacular traction
Who may be able to join
- 1-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
- <!-- -->
- dense cataract ,
- glaucoma, and
- previous retinal surgery.
Trial locations and contacts
No sites are listed yet.
magady mostafa, professor contact
About this study
To evulate changes in 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.
- Conditions
- ILM Peeling
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
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 posted18 Mar 2020
- Study startApr 2020 (estimated)
- Primary completion9 Feb 2021 (estimated)
- Study completion8 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ILM PeelingStudies 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
- NCT04312620
- Sponsor's protocol ID
- ILM peeling
- Status last verified
- Feb 2020
- First submitted
- 16 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Noma H, Funatsu H, Sakata K, Harino S, Mimura T, Hori S. Macular microcirculation in hypertensive patients with and without branch retinal vein occlusion. Acta Ophthalmol. 2009 Sep;87(6):638-42. doi: 10.1111/j.1755-3768.2008.01318.x. Epub 2008 Jul 8.
PubMed 18631327Higashide T, Ohkubo S, Hangai M, Ito Y, Shimada N, Ohno-Matsui K, Terasaki H, Sugiyama K, Chew P, Li KK, Yoshimura N. Influence of Clinical Factors and Magnification Correction on Normal Thickness Profiles of Macular Retinal Layers Using Optical Coherence Tomography. PLoS One. 2016 Jan 27;11(1):e0147782. doi: 10.1371/journal.pone.0147782. eCollection 2016.
PubMed 26814541
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of OCT and Visual Field Changes After Vitrectomy and ILM Peeling
- ClinicalTrials.gov ID
- NCT04312620
- Acronym / sponsor ID
- ILM peeling
- Conditions
- ILM Peeling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- 9 Feb 2021 (estimated)
- Study completion
- 8 Apr 2021 (estimated)
- First posted
- 18 Mar 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients withIdiopathic ERM,Primary full thickness macular hole,Lamellar macular hole, andVitromacular traction
Key inclusion criteria (4 listed)
- 1-Idiopathic ERM,
- Primary full thickness macular hole,
- Lamellar macular hole, and
- Vitromacular traction.
Key exclusion criteria (10 listed)
- 1-Patients with a secondary ERM,
- <!-- -->
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
ILM peeling
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Background: PubMed 18631327Noma H, Funatsu H, Sakata K, Harino S, Mimura T, Hori S. Macular microcirculation in hypertensive patients with and without branch retinal vein occlusion. Acta Ophthalmol. 2009 Sep;87(6):638-42. doi: 10.1111/j.1755-3768.2008.01318.x. Epub 2008 Jul 8.
- Results publication: PubMed 26814541Higashide T, Ohkubo S, Hangai M, Ito Y, Shimada N, Ohno-Matsui K, Terasaki H, Sugiyama K, Chew P, Li KK, Yoshimura N. Influence of Clinical Factors and Magnification Correction on Normal Thickness Profiles of Macular Retinal Layers Using Optical Coherence Tomography. PLoS One. 2016 Jan 27;11(1):e0147782. doi: 10.1371/journal.pone.0147782. eCollection 2016.
Related trials for ILM Peeling
Recruiting
Comparison Between Outcomes of Closure of Idiopathic Macular Hole Using Autologus Tenon Capsule Graft and Internal Limiting Membrane Flap Techniques (Pilot Study)
Macular Hole Surgery, ILM Peeling
Recruiting
Full-Thickness Macular Hole Surgery: A Comparison of Ten Techniques
Macular Holes
Recruiting
1ry Versus 2ry ILM Peeling in RD
Retinal Detachment Rhegmatogenous, ILM Peeling
Active, not recruiting
Fovea Sparing ILM Peeling in Diabetic Patients
Diabetes Mellitus
Active, not recruiting
Impact of ILM Peeling in RRD/ I-Peel
Retinal Detachment
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.
magady mostafa, professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of ILM Peeling, 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 18 Mar 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?
Contact almoatz bellah zohier mohamm,ed, master (01099490013, moatazmoh58@gmail.com), or a site near the patient. 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 NCT04312620, which also lists 2 linked publications.
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 18 Mar 2020.