Idiopathic Epiretinal Membranes
Conditions
Keywords
Idiopathic epiretinal membrane, internal limiting membrane, visual field, randomized controlled trial
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREEpiretinal membrane peeling
All patients will receive standard pars plana vitrectomy, followed by only epiretinal membrane peeling.
PROCEDUREEpiretinal membrane peeling combined with internal limiting membrane peeling
All patients will receive standard pars plana vitrectomy, followed by epiretinal membrane peeling and internal limiting membrane peeling.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The patients will be masked to the treatment group in this study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged \>18 years presenting to our hospital within the study period. * Patients diagnosed with idiopathic epiretinal membrane (ERM) based on examination. * Patients with best-corrected visual acuity (BCVA) ≤ 0.6 or the presence of metamorphopsia.
Exclusion criteria
* Patients with secondary ERM identified during preoperative evaluation (e.g., secondary to retinal vein occlusion). * Patients with concomitant ocular diseases affecting the macula, such as macular degeneration, macular schisis, or macular atrophy. * Patients with a history of ocular trauma or previous ocular surgery (except for cataract surgery). * Patients with severe systemic diseases contraindicated for surgery. * Patients with poor compliance or concomitant psychiatric disorders. * Patients who participated in other clinical trials during the follow-up period or who were lost to follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean deviation (MD) value | 6 months postoperatively | mean deviation (MD) value from postoperative Humphrey visual field testing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | 6 months postoperatively | uncorrected and corrected distance visual acuity |
| Ganglion cell complex | 6 months postoperatively | Ganglion cell complex parameters on macular OCT |
| Recurrence rate | 12 months postoperatively | Recurrence rate of ERM |
Countries
China
Contacts
Primary ContactYueyang Zhong, MD.
Outcome results
None listed