Epiretinal MembraneNCT07165626
Evaluation of Retinal Parameters in Patients With Epiretinal Membrane After Vitrectomy
A study testing Subtreshold micropulse laser therapy and Pars plana vitrectomy in people with Epiretinal Membrane and Macular Oedema, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Epiretinal Membrane, Macular Oedema, Macular Diseases
- What is being tested?
- Subtreshold micropulse laser therapy and Pars plana vitrectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 9 May 2024to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Epiretinal membrane (ERM) - either associated with metamorphopsia or causing a marked reduction in best corrected visual acuity
- Pseudophakia
Who cannot join
- Coexisting ocular or retinal diseases other than ERM
- Evidence of ocular inflammation or any active intraocular inflammatory process
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
First Department of Ophthalmology, Pomeranian Medical University
Szczecin
About this study
Official title: Evaluation of Morphological and Functional Changes in Eyes With Epiretinal Membrane After Vitrectomy
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.
Read more
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.
- Being tested
- Subtreshold micropulse laser therapy, Pars plana vitrectomy
- Medical subject headings
- Epiretinal Membrane, Macular Edema, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subtreshold micropulse laser therapyDevice
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.
Pars plana vitrectomyProcedure or surgery
Both groups will undergo pars plana vitrectomy (PPV) with epiretinal membrane (ERM) and internal limiting membrane (ILM) peeling prior to allocation to study arms.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Subtreshold micropulse laser therapy; Procedure: Pars plana vitrectomy |
| Nonlaser group | Other | Pars plana vitrectomy (PPV) performed without subsequent subthreshold micropulse laser therapy (SMLT). Receives: Procedure: Pars plana vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month (pre-laser) and 4 months postoperatively.
Secondary outcomes (10)
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).
Measured: Baseline (pre-op), 1 month, and 4 months post-op.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline (pre-op), 1 month, and 4 months post-op.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start9 May 2024
- Primary completionSep 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epiretinal MembraneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment with participants randomized 1:1 to either the laser-treated group or the control (nonlaser) group.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Machalińska, Prof., MD, PhD, Principal investigator, First Department of Ophthalmology, Pomeranian Medical University in Szczecin, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165626
- Sponsor's protocol ID
- KB-006/25/2024
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Morphological and Functional Changes in Eyes With Epiretinal Membrane After Vitrectomy
- ClinicalTrials.gov ID
- NCT07165626
- Acronym / sponsor ID
- KB-006/25/2024
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 9 May 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment with participants randomized 1:1 to either the laser-treated group or the control (nonlaser) group.
| Arm | Type | Receives |
|---|---|---|
| Laser-treated group | Active comparator | Device: Subtreshold micropulse laser therapy, Procedure: Pars plana vitrectomyAdditional 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). |
| Nonlaser group | Other | Procedure: Pars plana vitrectomyPars plana vitrectomy (PPV) performed without subsequent subthreshold micropulse laser therapy (SMLT). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Epiretinal membrane (ERM) - either associated with metamorphopsia or causing a marked reduction in best corrected visual acuity
- Pseudophakia
Key exclusion criteria (2 listed)
- Coexisting ocular or retinal diseases other than ERM
- Evidence of ocular inflammation or any active intraocular inflammatory process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subtreshold micropulse laser therapyLaser-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. | Device | Laser-treated group |
| Pars plana vitrectomyBoth groups will undergo pars plana vitrectomy (PPV) with epiretinal membrane (ERM) and internal limiting membrane (ILM) peeling prior to allocation to study arms. | Procedure or surgery | Laser-treated group, Nonlaser group |
Primary outcome
Change in BCVA from 1 month post-PPV (pre-laser) to 4 months post-PPV.
Time frame: 1 month (pre-laser) and 4 months postoperatively.
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.
10 secondary outcomes
Change in mfERG P1-wave retinal response density in rings R1-R6.
Time frame: Baseline (pre-op), 1 month, and 4 months post-op.
Change in mfERG P1-wave implicit time in rings R1-R6.
Time frame: Baseline (pre-op), 1 month, and 4 months post-op.
Change in average threshold on microperymetry.
Time frame: Baseline (pre-op), 1 month, and 4 months post-op.
Change in fixation stability P1 and P2 on microperymetry.
Time frame: Baseline (pre-op), 1 month, and 4 months post-op.
Change in fixation variability on microperymetry.
Time frame: Baseline (pre-op), 1 month, and 4 months post-op.
Change in retinal thickness on EDI-OCT.
Time frame: Baseline (pre-op), 1 month, and 4 months post-op.
Change in total retinal volume on EDI-OCT.
Time frame: Baseline (pre-op), 1 month, and 4 months post-op.
Change in subfoveal choroidal thickness on EDI-OCT.
Time frame: Baseline (pre-op), 1 month, and 4 months post-op.
Change in choroidal area on EDI-OCT.
Time frame: Baseline (pre-op), 1 month, and 4 months post-op.
Change in FAZ area in the SVC and DVC on OCTA.
Time frame: Baseline (pre-op), 1 month, and 4 months post-op.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Machalińska, Prof., MD, PhD principal investigator
First Department of Ophthalmology, Pomeranian Medical University in Szczecin, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subtreshold micropulse laser therapy and Pars plana vitrectomy in people with Epiretinal Membrane and Macular Oedema, run by Pomeranian Medical University Szczecin at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BCVA from 1 month post-PPV (pre-laser) to 4 months post-PPV. (time frame: 1 month (pre-laser) and 4 months postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.