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| ID | Type | Description | Link |
|---|---|---|---|
| K4698 | Other Identifier | Peking Union Medical College Hospital |
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| Name | Class |
|---|---|
| Peking Union Medical College | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Conventional Vitrectomy (PPV) | Active Comparator | Standard pars plana vitrectomy is performed. Posterior vitreous detachment induction and core vitreous removal are conducted before membrane peeling. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimal Vitrectomy Surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| BCVA change from baseline to 12 months | Change in best-corrected visual acuity (logMAR) from baseline to 12 months postoperatively. | Baseline, 1 week, 1 month, 3 months, 6 months, 12 months |
| Change in central retinal thickness (CRT) by OCT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weihong Yu, MD | Contact | +8613671214306 | yuweihongpumch@163.com | |
| Xufeng Zhao | Contact | +8619121036553 | yezhong019@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Weihong Yu, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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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| ID | Term |
|---|---|
| D019773 | Epiretinal Membrane |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
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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.
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Participants are masked to the intervention arm assignment. Surgical staff, investigators, and outcomes assessors are not masked due to the nature of the surgical procedures.
| Conventional Vitrectomy | Procedure | Standard pars plana vitrectomy is performed with posterior vitreous detachment induction and core vitreous removal prior to epiretinal membrane peeling. |
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Change in macular central retinal thickness as assessed by OCT.
| Baseline, 1 week, 1 month, 3 months, 6 months, 12 months |
| Epiretinal membrane recurrence rate | Recurrence of epiretinal membrane at 12-month follow-up. | 12 months |