Epiretinal Membrane, Macular Edema (ME), Nuclear Cataract
Conditions
Keywords
Idiopathic Epiretinal Membrane (ERM), Minimal Vitrectomy Surgery (MVS), Nonvitrectomizing Vitreous Surgery (NVS), pars plana Vitrectomy (PPV)
Brief 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. 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.
Interventions
PROCEDUREMinimal Vitrectomy 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.
PROCEDUREConventional Vitrectomy
Standard pars plana vitrectomy is performed with posterior vitreous detachment induction and core vitreous removal prior to epiretinal membrane peeling.
Sponsors
Peking Union Medical College
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years. 2. Diagnosis of idiopathic epiretinal membrane (ERM) confirmed by clinical examination and OCT imaging. 3. Clear ocular media allowing adequate fundus imaging. 4. Phakic eye. 5. Ability and willingness to provide written informed consent.
Exclusion criteria
1. Prior cataract surgery or advanced cataract requiring combined surgery. Co-existing retinal diseases (e.g., diabetic retinopathy, retinal detachment, retinal vein occlusion). 2. Systemic conditions preventing safe surgery or follow-up. 3. History of prior ocular or periocular corticosteroid use, including intraocular injection, periocular injection, or long-term topical corticosteroid eye drops.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cataract progression assessed by LOCS III and DLI | Baseline, 12 months | Cataract progression evaluated by Lens Opacities Classification System III (LOCS III) grading and Dysfunctional Lens Index (DLI) changes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BCVA change from baseline to 12 months | Baseline, 1 week, 1 month, 3 months, 6 months, 12 months | Change in best-corrected visual acuity (logMAR) from baseline to 12 months postoperatively. |
| Change in central retinal thickness (CRT) by OCT | Baseline, 1 week, 1 month, 3 months, 6 months, 12 months | Change in macular central retinal thickness as assessed by OCT. |
| Epiretinal membrane recurrence rate | 12 months | Recurrence of epiretinal membrane at 12-month follow-up. |
Countries
China
Contacts
Primary ContactWeihong Yu, MD
Backup ContactXufeng Zhao
Outcome results
None listed