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Idiopathic epiretinal membrane (ERM) is an age-related degenerative retinal condition. One of the primary treatment approaches is vitrectomy combined with epiretinal membrane peeling. However, whether to concurrently perform internal limiting membrane (ILM) peeling remains clinically controversial. Therefore, this study aims to compare the efficacy and safety of performing versus omitting ILM peeling during idiopathic ERM surgery.
Idiopathic epiretinal membrane (ERM) is an age-related degenerative retinal condition. Its pathological hallmark is the formation of a fibrocellular membrane in the macular region, which can lead to retinal structural distortion and visual impairment. Epidemiological studies indicate that ERM is age-related, occurs more frequently unilaterally, and shows a positive correlation with advancing age, with incidence rates of 2% to 20% in individuals aged 50 to 70 years. The severity primarily depends on the location and thickness of the membrane and the presence of macular pseudoholes, manifesting as symptoms including visual field distortion (metamorphopsia), micropsia, and central vision loss. Studies suggest that ERM patients experiencing progressive visual decline, best-corrected visual acuity (BCVA) ≤ 0.6, or severe metamorphopsia require surgical intervention. There remains a lack of high-quality prospective RCTs evaluating the therapeutic outcomes of vitrectomy combined with ERM peeling with or without ILM peeling in idiopathic ERM patients. Therefore, this study aims to compare the efficacy and safety of performing versus omitting ILM peeling during idiopathic ERM surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internal limiting membrane (ILM) peeling group | Experimental | The patients will receive standard pars plana vitrectomy with ERM peeling combined with ILM peeling within an area of 3-4 disc diameters centered on the macula. |
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| No ILM peeling group | Active Comparator | The patients will receive standard pars plana vitrectomy with only ERM peeling |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epiretinal membrane peeling | Procedure | All patients will receive standard pars plana vitrectomy, followed by only epiretinal membrane peeling. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean deviation (MD) value | mean deviation (MD) value from postoperative Humphrey visual field testing. | 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | uncorrected and corrected distance visual acuity | 6 months postoperatively |
| Ganglion cell complex | Ganglion cell complex parameters on macular OCT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yueyang Zhong, MD. | Contact | +8618868125901 | yyzbzhong@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Center of the Second Affiliated Hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310058 | China |
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The patients will be masked to the treatment group in this study.
| Epiretinal membrane peeling combined with internal limiting membrane peeling | Procedure | All patients will receive standard pars plana vitrectomy, followed by epiretinal membrane peeling and internal limiting membrane peeling. |
|
| 6 months postoperatively |
| Recurrence rate | Recurrence rate of ERM | 12 months postoperatively |