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The goal of this interventional study is to assess the dynamics of structural and functional retinal changes in eyes with epiretinal membrane (ERM) after pars plana vitrectomy (PPV). Other study objectives include:
Researchers will compare a laser-treated group (additional subthreshold micropulse yellow laser (577 nm) at 1 month post-PPV) with a nonlaser group (no additional laser) to see whether early postoperative subtreshold micropulse laser therapy (SMLT) affects selected functional and morphometric retinal parameters after ERM peeling.
This prospective, randomized, controlled, single-center study includes 100 pseudophakic patients scheduled for surgical ERM removal.
Eligibility requires a visually significant ERM with metamorphopsia and/or reduced best-corrected visual acuity.
Participants are classified preoperatively by OCT-based Govetto staging and randomized 1:1 to either the laser-treated group or the non-laser (control) group. All patients undergo standard 25-gauge PPV with ERM peeling, followed by ILM peeling and SF₆ gas tamponade, performed by a single experienced vitreoretinal surgeon.
Follow-up visits occur preoperatively, and at 1 and 4 months postoperatively; SMLT is performed at 1 month in the laser arm. Baseline questionnaire captures metamorphopsia presence (yes/no) and duration (<6, 6-12, >12 months).
Assessments include:
Statistical analyses will be performed at a significance level of p<0.05, using appropriate parametric or nonparametric methods selected based on data distribution and measurement scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser-treated group | Active Comparator | Additional subthreshold micropulse laser therapy (SMLT) using a 577 nm solid-state yellow diode laser, applied to the macular area (thirty 5 × 5 spot sizes of 160 µm, zero-spot spacing, including the fovea; fixed power 250 mW; exposure 200 ms; micropulse mode, 5% duty cycle) performed 1 month after pars plana vitrectomy (PPV). |
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| Nonlaser group | Other | Pars plana vitrectomy (PPV) performed without subsequent subthreshold micropulse laser therapy (SMLT). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subtreshold micropulse laser therapy | Device | Laser-treated group will receive additional subthreshold micropulse laser therapy (SMLT) 1 month after pars plana vitrectomy (PPV), using a 577 nm solid-state yellow diode laser applied to the macular area (thirty 5 × 5 spot sizes of 160 µm, zero-spot spacing, including the fovea; fixed power 250 mW; exposure time 200 ms; micropulse mode, 5% duty cycle). Control group (nonlaser group) will not receive additional laser treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BCVA from 1 month post-PPV (pre-laser) to 4 months post-PPV. | Between-group difference (laser-treated group vs nonlaser group) in change in best corrected visual acuity (BCVA) from Month 1 to Month 4. BCVA measured using Snellen and ETDRS charts. | 1 month (pre-laser) and 4 months postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mfERG P1-wave retinal response density in rings R1-R6. | Multifocal electroretinography (mfERG) P1-wave retinal response density (nV/deg²) in rings R1-R6. Analyses will include between-group changes from Month 1 to Month 4 and overall within-subject changes from baseline to Month 1 and from baseline to Month 4 (across both arms). | Baseline (pre-op), 1 month, and 4 months post-op. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Machalińska, Prof., MD, PhD | First Department of Ophthalmology, Pomeranian Medical University in Szczecin, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Department of Ophthalmology, Pomeranian Medical University | Szczecin | Poland |
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| ID | Term |
|---|---|
| D019773 | Epiretinal Membrane |
| D008269 | Macular Edema |
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
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Parallel assignment with participants randomized 1:1 to either the laser-treated group or the control (nonlaser) group.
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| Pars plana vitrectomy | Procedure | Both groups will undergo pars plana vitrectomy (PPV) with epiretinal membrane (ERM) and internal limiting membrane (ILM) peeling prior to allocation to study arms. |
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| Change in mfERG P1-wave implicit time in rings R1-R6. | Multifocal electroretinography (mfERG) P1-wave implicit (peak) time (ms) in rings R1-R6. Analyses will include between-group changes from Month 1 to Month 4 and overall within-subject changes from baseline to Month 1 and from baseline to Month 4 (across both arms). | Baseline (pre-op), 1 month, and 4 months post-op. |
| Change in average threshold on microperymetry. | Average threshold (dB) on microperymetry. Analyses will include between-group changes from Month 1 to Month 4 and overall within-subject changes from baseline to Month 1 and from baseline to Month 4 (across both arms). | Baseline (pre-op), 1 month, and 4 months post-op. |
| Change in fixation stability P1 and P2 on microperymetry. | Fixation stability P1 and P2 (%) on microperymetry. Analyses will include between-group changes from Month 1 to Month 4 and overall within-subject changes from baseline to Month 1 and from baseline to Month 4 (across both arms). | Baseline (pre-op), 1 month, and 4 months post-op. |
| Change in fixation variability on microperymetry. | Fixation variability via 63% and 95% bivariate contour ellipse area (BCEA) on microperymetry (deg²). Analyses will include between-group changes from Month 1 to Month 4 and overall within-subject changes from baseline to Month 1 and from baseline to Month 4 (across both arms). | Baseline (pre-op), 1 month, and 4 months post-op. |
| Change in retinal thickness on EDI-OCT. | Retinal thickness in the nine Early Treatment Diabetic Retinopathy Study (ETDRS) subfields (μm) on enhanced depth imaging optical coherence tomography (EDI-OCT). Analyses will include between-group changes from Month 1 to Month 4 and overall within-subject changes from baseline to Month 1 and from baseline to Month 4 (across both arms). | Baseline (pre-op), 1 month, and 4 months post-op. |
| Change in total retinal volume on EDI-OCT. | Total retinal volume (mm³) on EDI-OCT. Analyses will include between-group changes from Month 1 to Month 4 and overall within-subject changes from baseline to Month 1 and from baseline to Month 4 (across both arms). | Baseline (pre-op), 1 month, and 4 months post-op. |
| Change in subfoveal choroidal thickness on EDI-OCT. | Subfoveal choroidal thickness (μm) on EDI-OCT. Analyses will include between-group changes from Month 1 to Month 4 and overall within-subject changes from baseline to Month 1 and from baseline to Month 4 (across both arms). | Baseline (pre-op), 1 month, and 4 months post-op. |
| Change in choroidal area on EDI-OCT. | Choroidal area (mm²) on EDI-OCT. Analyses will include between-group changes from Month 1 to Month 4 and overall within-subject changes from baseline to Month 1 and from baseline to Month 4 (across both arms). | Baseline (pre-op), 1 month, and 4 months post-op. |
| Change in FAZ area in the SVC and DVC on OCTA. | Foveal avascular zone (FAZ) area in the superficial vascular complex (SVC) (mm²) and deep vascular complex (DVC) (mm²) on OCT angiography (OCTA). Analyses will include between-group changes from Month 1 to Month 4 and overall within-subject changes from baseline to Month 1 and from baseline to Month 4 (across both arms). | Baseline (pre-op), 1 month, and 4 months post-op. |