Evaluation of Retinal Parameters in Patients With Epiretinal Membrane After Vitrectomy

NCT07165626 | Enrolling By Invitation

• 1 other identifier: KB-006/25/2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• Identification of preoperative prognostic factors associated with better postoperative outcomes.
• Evaluation of the utility of advanced, highly specialized retinal function testing as diagnostic-prognostic tools in patients after ERM surgery.
• Definition of updated qualification criteria and surgical indications for vitrectomy in patients with ERM. 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:
• best corrected visual acuity (BCVA) \[Snellen and ETDRS charts\]
• enhanced depth imaging optical coherence tomography (EDI-OCT) \[retinal thickness in the nine Early Treatment Diabetic Retinopathy Study (ETDRS) subfields (μm); total retinal volume (mm³); subfoveal choroidal thickness (μm); choroidal area (mm²)\]
• OCT angiography (OCTA) \[foveal avascular zone (FAZ) area in both the superficial (SVC) and deep vascular complexes (DVC) (mm²)\]
• multifocal electroretinography (mfERG) \[P1-wave retinal response density (nV/deg²) in rings R1-R6; P1-wave implicit (peak) time in rings R1-R6 (ms)\]
• microperimetry (average threshold (dB); fixation stability P1/P2; fixation variability via 63% and 95% bivariate contour ellipse area (BCEA)\]
• wide-field fundus imaging 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.

Conditions

Epiretinal Membrane; Macular Oedema; Macular Diseases; Retinal Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (10)

• Change in mfERG P1-wave retinal response density in rings R1-R6.

  Baseline (pre-op), 1 month, and 4 months post-op.

• Change in mfERG P1-wave implicit time in rings R1-R6.

  Baseline (pre-op), 1 month, and 4 months post-op.

• Change in average threshold on microperymetry.

  Baseline (pre-op), 1 month, and 4 months post-op.

• Change in fixation stability P1 and P2 on microperymetry.

  Baseline (pre-op), 1 month, and 4 months post-op.

• Change in fixation variability on microperymetry.

  Baseline (pre-op), 1 month, and 4 months post-op.

Study Arms (2)

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).

Device: Subtreshold micropulse laser therapy; Procedure: Pars plana vitrectomy

Nonlaser group

OTHER

Pars plana vitrectomy (PPV) performed without subsequent subthreshold micropulse laser therapy (SMLT).

Procedure: Pars plana vitrectomy

Interventions

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.

Laser-treated group

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.

Laser-treated group; Nonlaser group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Epiretinal membrane (ERM) - either associated with metamorphopsia or causing a marked reduction in best corrected visual acuity
• Pseudophakia

You may not qualify if:

• Coexisting ocular or retinal diseases other than ERM
• Evidence of ocular inflammation or any active intraocular inflammatory process

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Study Sites (1)

First Department of Ophthalmology, Pomeranian Medical University

Szczecin, Poland

Location

MeSH Terms

Conditions

Epiretinal Membrane; Macular Edema; Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases; Macular Degeneration; Retinal Degeneration

Study Officials

• Anna Machalińska, Prof., MD, PhD

  First Department of Ophthalmology, Pomeranian Medical University in Szczecin, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel assignment with participants randomized 1:1 to either the laser-treated group or the control (nonlaser) group.

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: September 10, 2025
• Study Start: May 9, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)