Epiretinal MembraneMVS-ERMNCT07019896
Minimal Vitrectomy Surgery for Epiretinal Membrane
A study testing Minimal Vitrectomy Surgery and Conventional Vitrectomy in people with Epiretinal Membrane and Macular Edema (ME), run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This multicenter randomized controlled trial evaluates Minimal Vitrectomy Surgery (MVS) versus conventional vitrectomy for idiopathic epiretinal membrane (ERM). The primary endpoints include visual acuity improvement and cataract progression after 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epiretinal Membrane, Macular Edema (ME), Nuclear Cataract
- What is being tested?
- Minimal Vitrectomy Surgery and Conventional Vitrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years.
- Diagnosis of idiopathic epiretinal membrane (ERM) confirmed by clinical examination and OCT imaging.
- Clear ocular media allowing adequate fundus imaging.
- Phakic eye.
- Ability and willingness to provide written informed consent.
Who cannot join
- Prior cataract surgery or advanced cataract requiring combined surgery. Co-existing retinal diseases (e.g., diabetic retinopathy, retinal detachment, retinal vein occlusion).
- Systemic conditions preventing safe surgery or follow-up.
- History of prior ocular or periocular corticosteroid use, including intraocular injection, periocular injection, or long-term topical corticosteroid eye drops.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
19121036553, yezhong019@163.com
About this study
Official title: Minimal Vitrectomy Surgery (MVS) Versus Conventional Vitrectomy for the Treatment of Idiopathic Epiretinal Membrane: A Multicenter Randomized Controlled Trial
This multicenter randomized controlled trial evaluates Minimal Vitrectomy Surgery (MVS) versus conventional vitrectomy for idiopathic epiretinal membrane (ERM). The primary endpoints include visual acuity improvement and cataract progression after 12 months. MVS aims to minimize vitreous removal while ensuring complete membrane removal through adaptive limited vitrectomy.
Read the detailed description
Idiopathic epiretinal membrane (ERM) is characterized by fibrocellular proliferation on the retinal surface, leading to macular edema, metamorphopsia, and visual impairment. Traditional treatment involves pars plana vitrectomy (PPV) with posterior vitreous detachment (PVD) induction and core vitrectomy, which may increase the risk of postoperative cataract.
Minimal Vitrectomy Surgery (MVS) is a modified surgical approach designed to minimize vitreous removal and preserve the hyaloid. The epiretinal membrane is directly peeled through the intact vitreous. If pre-existing vitreous floaters or membrane fragments remain after peeling and cannot be removed safely with micro-forceps, limited localized vitrectomy is selectively performed to eliminate these floaters and avoid postoperative visual disturbances.
This trial aims to evaluate the efficacy and safety of MVS compared to conventional vitrectomy, focusing on visual improvement, macular thickness, cataract progression, ERM recurrence, and intraoperative complications.
- Conditions
- Epiretinal Membrane, Macular Edema (ME), Nuclear Cataract
- Being tested
- Minimal Vitrectomy Surgery, Conventional Vitrectomy
- Keywords
- Idiopathic Epiretinal Membrane (ERM), Minimal Vitrectomy Surgery (MVS), Nonvitrectomizing Vitreous Surgery (NVS), pars plana Vitrectomy (PPV)
- Medical subject headings
- Epiretinal Membrane, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal Vitrectomy SurgeryProcedure or surgery
The epiretinal membrane is peeled directly through the intact vitreous. Limited localized vitrectomy is selectively performed if pre-existing floaters or membrane fragments remain after peeling.
Conventional VitrectomyProcedure or surgery
Standard pars plana vitrectomy is performed with posterior vitreous detachment induction and core vitreous removal prior to epiretinal membrane peeling.
| Study group | Role | What they receive |
|---|---|---|
| Minimal Vitrectomy Surgery (MVS) | Experimental | The epiretinal membrane is peeled directly through the intact vitreous. Limited vitrectomy is selectively performed if pre-existing floaters or membrane fragments remain after peeling and cannot be removed safely with forceps. Receives: Procedure: Minimal Vitrectomy Surgery |
| Conventional Vitrectomy (PPV) | Active comparator | Standard pars plana vitrectomy is performed. Posterior vitreous detachment induction and core vitreous removal are conducted before membrane peeling. Receives: Procedure: Conventional Vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cataract progression assessed by LOCS III and DLI
Cataract progression evaluated by Lens Opacities Classification System III (LOCS III) grading and Dysfunctional Lens Index (DLI) changes.
Measured: Baseline, 12 months
Secondary outcomes (3)
BCVA change from baseline to 12 months
Change in best-corrected visual acuity (logMAR) from baseline to 12 months postoperatively.
Measured: Baseline, 1 week, 1 month, 3 months, 6 months, 12 months
Change in central retinal thickness (CRT) by OCT
Change in macular central retinal thickness as assessed by OCT.
Measured: Baseline, 1 week, 1 month, 3 months, 6 months, 12 months
Epiretinal membrane recurrence rate
Recurrence of epiretinal membrane at 12-month follow-up.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Dec 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (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.
- More trials run by Peking Union Medical College HospitalThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a multicenter, randomized, parallel-group controlled trial. Patients with idiopathic epiretinal membrane are randomly assigned to receive either Minimal Vitrectomy Surgery (MVS) or Conventional Pars Plana Vitrectomy (PPV). Randomization is stratified across 14 participating centers. Participants in the MVS group undergo membrane peeling without core vitrectomy or posterior vitreous detachment induction, with selective limited vitrectomy performed if necessary. The PPV group undergoes standard vitrectomy with core vitreous removal and posterior vitreous detachment prior to membrane peeling.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College
- Responsible party
- Principal investigator, Weihong Yu, Peking Union Medical College Hospital
- Investigators
- Weihong Yu, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019896
- Sponsor's protocol ID
- 2024-I2M-C&T-B-028
- Other IDs
- K4698
- Acronym
- MVS-ERM
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to patient privacy protection and the absence of participant consent for data sharing. The study data will be used exclusively for internal research purposes and regulatory submissions.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Vitrectomy Surgery (MVS) Versus Conventional Vitrectomy for the Treatment of Idiopathic Epiretinal Membrane: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07019896
- Acronym / sponsor ID
- MVS-ERM / 2024-I2M-C&T-B-028
- Conditions
- Epiretinal Membrane, Macular Edema (ME), Nuclear Cataract
- Keywords
- Idiopathic Epiretinal Membrane (ERM), Minimal Vitrectomy Surgery (MVS), Nonvitrectomizing Vitreous Surgery (NVS), pars plana Vitrectomy (PPV)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Peking Union Medical College
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 13 Jun 2025 (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.
This multicenter randomized controlled trial evaluates Minimal Vitrectomy Surgery (MVS) versus conventional vitrectomy for idiopathic epiretinal membrane (ERM). The primary endpoints include visual acuity improvement and cataract progression after 12 months. MVS aims to minimize vitreous removal while ensuring complete membrane removal through adaptive limited vitrectomy.
Detailed description
Idiopathic epiretinal membrane (ERM) is characterized by fibrocellular proliferation on the retinal surface, leading to macular edema, metamorphopsia, and visual impairment. Traditional treatment involves pars plana vitrectomy (PPV) with posterior vitreous detachment (PVD) induction and core vitrectomy, which may increase the risk of postoperative cataract.
Minimal Vitrectomy Surgery (MVS) is a modified surgical approach designed to minimize vitreous removal and preserve the hyaloid. The epiretinal membrane is directly peeled through the intact vitreous. If pre-existing vitreous floaters or membrane fragments remain after peeling and cannot be removed safely with micro-forceps, limited localized vitrectomy is selectively performed to eliminate these floaters and avoid postoperative visual disturbances.
This trial aims to evaluate the efficacy and safety of MVS compared to conventional vitrectomy, focusing on visual improvement, macular thickness, cataract progression, ERM recurrence, and intraoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a multicenter, randomized, parallel-group controlled trial. Patients with idiopathic epiretinal membrane are randomly assigned to receive either Minimal Vitrectomy Surgery (MVS) or Conventional Pars Plana Vitrectomy (PPV). Randomization is stratified across 14 participating centers. Participants in the MVS group undergo membrane peeling without core vitrectomy or posterior vitreous detachment induction, with selective limited vitrectomy performed if necessary. The PPV group undergoes standard vitrectomy with core vitreous removal and posterior vitreous detachment prior to membrane peeling.
| Arm | Type | Receives |
|---|---|---|
| Minimal Vitrectomy Surgery (MVS) | Experimental | Procedure: Minimal Vitrectomy SurgeryThe epiretinal membrane is peeled directly through the intact vitreous. Limited vitrectomy is selectively performed if pre-existing floaters or membrane fragments remain after peeling and cannot be removed safely with forceps. |
| Conventional Vitrectomy (PPV) | Active comparator | Procedure: Conventional VitrectomyStandard pars plana vitrectomy is performed. Posterior vitreous detachment induction and core vitreous removal are conducted before membrane peeling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Diagnosis of idiopathic epiretinal membrane (ERM) confirmed by clinical examination and OCT imaging.
- Clear ocular media allowing adequate fundus imaging.
- Phakic eye.
- Ability and willingness to provide written informed consent.
Key exclusion criteria (3 listed)
- Prior cataract surgery or advanced cataract requiring combined surgery. Co-existing retinal diseases (e.g., diabetic retinopathy, retinal detachment, retinal vein occlusion).
- Systemic conditions preventing safe surgery or follow-up.
- History of prior ocular or periocular corticosteroid use, including intraocular injection, periocular injection, or long-term topical corticosteroid eye drops.
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 |
|---|---|---|
| Minimal Vitrectomy SurgeryThe epiretinal membrane is peeled directly through the intact vitreous. Limited localized vitrectomy is selectively performed if pre-existing floaters or membrane fragments remain after peeling. | Procedure or surgery | Minimal Vitrectomy Surgery (MVS) |
| Conventional VitrectomyStandard pars plana vitrectomy is performed with posterior vitreous detachment induction and core vitreous removal prior to epiretinal membrane peeling. | Procedure or surgery | Conventional Vitrectomy (PPV) |
Primary outcome
Cataract progression assessed by LOCS III and DLI
Time frame: Baseline, 12 months
Cataract progression evaluated by Lens Opacities Classification System III (LOCS III) grading and Dysfunctional Lens Index (DLI) changes.
3 secondary outcomes
BCVA change from baseline to 12 months
Time frame: Baseline, 1 week, 1 month, 3 months, 6 months, 12 months
Change in central retinal thickness (CRT) by OCT
Time frame: Baseline, 1 week, 1 month, 3 months, 6 months, 12 months
Epiretinal membrane recurrence rate
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to patient privacy protection and the absence of participant consent for data sharing. The study data will be used exclusively for internal research purposes and regulatory submissions.
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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.
Weihong Yu, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal Vitrectomy Surgery and Conventional Vitrectomy in people with Epiretinal Membrane and Macular Edema (ME), run by Peking Union Medical College Hospital at 1 site in China.
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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 13 Jun 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weihong Yu, MD (+8613671214306, yuweihongpumch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cataract progression assessed by LOCS III and DLI (time frame: Baseline, 12 months). 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 13 Jun 2025.